Timeline of the Natural Products Industry

By James J. Gormley
Ever wonder how we got here? Well, NOW Foods asked me to draft a timeline of the natural products industry---which I am happy to share with the natural products/health-food industry and consumers, The Gormley Files readers and NOW Foods Health E-News subscribers. Please let me know what major milestones are missing (or edits are needed) and I will be happy to include in updated versions of this document.

1790s
Thomsonianism (a form of herbalism) is developed by Samuel Thomson, a New Hampshire farmer.

1812-1870s
Early OTC (over the counter) drug forerunners, patent medicines, are in their heyday in the U.S. with mercury-laced concoctions, such as Swaim’s Panacea.
 



1820s-1830s
Homeopathy is established in the U.S.

1820s
In the late 1820s, Eclecticism (similar to naturopathy) is started by New Yorker Wooster Beach.
                                               
1840s                                           
Father Sebastian Kneipp’s “water cure” and herbal remedies become popular in the U.S.

1859
Florence Nightingale writes: “Nature alone cures […] What nursing has to do is put the patient in the best condition for nature to act upon him.”

1870s
Mary Baker Eddy, the foundress of Christian Science, is greatly influenced by the “magnetic healing” (or Mesmerism) of Austrian physician Franz Mesmer.

Osteopathy (originally a system of musculoskeletal manipulation) is begun by Andrew Taylor Still; his osteopathic school is opened in 1892, today called A.T. Still University (ATSU).

1890s
The nutritional integrity of  the American food supply is  devastated as millers begin using “sophisticated refining machinery [that] remove the germ and many vitamins and minerals from wheat and other whole grains and produce glistening, nutritionally inadequate white flour,” according to Frank Murray in More Than One Slingshot (1984).

1895
Iowan Daniel David Palmer discovers and describes chiropractic manipulation, the year the first chiropractic school opened.

1896
After 1896, Benedict Lust, founds American naturopathy in the U.S., initially to popularize Fr. Kneipp’s hydropathy, which had faded after the Civil War. Lust blends manipulation procedures with hydropathic treatments, herbal remedies and other natural approaches.

1896-1938
The country’s first health-food stores emerge.

1900
Twenty percent of all doctors are alternative physicians: there are 10,000 homeopaths, 5,000 Eclectics, 5,000 other holistic physicians and 100,000 allopaths.

1910-1930
The American Medical Association (AMA) and a lobby of early “modern” pharmacies are embarrassed by the Flexner Report of 1910 (which made disease-focused, or allopathic, medicine look bad) and work together to mainly run natural medicine “out of town,” focusing especially on Eclectic, naturopathic and homeopathic medical schools. By 1930, aside from osteopathic and chiropractic schools, alternative medicine has been dealt a severe blow.

1936
By 1936, Chicago baker, Anthony Berhalter, organizes a group of retailers and suppliers to meet in Chicago to form the American Health Foods Association (AHFA).

1937
Chicago’s 1937 convention is held at the old Auditorium Hotel and consisted of 15 booths, and includes: Tam Products (today called American Health); Elam Mills; Battle Creek Scientific Foods; H.W. Walker Inc.; and Modern Diet Products.

1938
The first industry trade magazine, Health Foods Retailing, begins publication.

The AHFA is re-named the National Health Foods Association (NHFA), whose first officers included such industry leaders as Paul Bragg and Lelord Kordell. The newly re-named association’s first convention is held at Chicago’s Sherman Hotel and attracts more than 1,000 consumers and industry members.

The Federal Food Drug and Cosmetic Act is enacted, mainly in response to deaths from the drug, Elixir Sulfanilamide.

Better Nutrition magazine is first published by the same company that began Health Foods Retailing.

Congress passes the Food Drug and Cosmetic (FDC) Act, which is the first regulation to establish labeling requirements and daily minimum levels for several vitamins and minerals.

1943
The NHFA becomes the National Dietary Foods Association (NDFA).

1946
The NDFA holds its convention at Chicago’s Hotel Continental.

1951
The NDFA’s annual convention is held at Detroit’s Hotel Book-Cadillac and showcases nearly 100 exhibitors and over 300 attendees.

1953
At a pharmacists’ convention in Philadelphia, attendees vote to push for legislation making all vitamins, minerals and food supplements available only in drug stores, a move fought against vigorously by the health-food movement.

1955
The natural products industry forms the Public Relations, Education, Legal, Legislation and Lobbying program (PELL) to counter attacks against the health-food industry in the media and in legislation.

Adelle Davis, a nutritional pioneer who would author several influential books on nutrition, addresses the industry for the first time.

1957
It is reported that a Minnesota law requiring vitamins to be sold in pharmacies has been overturned; vitamins can now be sold in any food store in that state.
1958
Regional health food associations have grown by now, including: Northern California Nutritional Foods Retailers Association, the Southern California Nutritional Association and the Northwest Dietary Foods Association, which convene together to hold the West Coast Dietary Foods Fair in Portland, Oregon.

The Food Additives Amendment to the FDC is passed. It includes restrictive provisions, such as prohibiting the use of several minerals in supplement preparations.

1960

In December, government agents enter the warehouses of the Balanced Foods Company in New York City and seize many copies of Folk Medicine and Arthritis and Folk Medicine, two popular books by the late doctor, D.C. Jarvis. The agents also seize bottles of vinegar and honey, since they were referred to in Jarvis’ books. The FDA brought suit against Balanced Foods in Federal District Court in New York City on the grounds that the vinegar and honey products constituted “misbranded drugs”! Milton Bass won this case … for consumers and the industry.

Dr. Carlton Fredericks’ Eat, Live and Be Merry is published.

1961
During a 1961 FDA inspection of American Health (then American Dietaids), a hidden tape recorder carried by an inspector malfunctions, revealing its presence to company officials.

This practice continued, however, and would later be acknowledged in sworn testimony at a Senate subcommittee hearing on Administrative Practice and Procedure in 1965.

1962
At its annual convention, the NDFA warns its members of the threat posed by proposed FDA regulations that would severely harm the health-food industry. The law firm of Bass and Friend, headed by industry advocate Milton Bass, is hired to represent the NDFA and the industry.

Niacin Therapy in Psychiatry by Dr. Abram Hoffer is published.

Silent Spring by Rachel Carson, a book credited with singlehandedly launching the environmental movement, is published.

1963
The Codex Alimentarius Commission (CAC) is officially created in 1963 by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) to “develop food standards, guidelines and related texts such as codes of practice.” The main purposes of this commission are said to be: “protecting health of the consumers,” “ensuring fair trade practices in the food trade” and “promoting coordination of all food standards.”

1965
Dr. Carlton Fredericks’ Low-Carbohydrate Diet is published.

1966
On June 18th, the U.S. Food and Drug Administration (FDA) announces that it is going to ban nutrient potencies above 100% of the RDAs by classifying the over-100% products as drugs. The FDA also announces labeling restrictions that would have forbidden the inclusion of any useful information on dietary supplements.

The proposed regulations are called “The Vitamin Volstead Act” by the health-food industry since they would have served as a 1966 version of Prohibition, in this case in reference to dietary supplements.

A massive industry and consumer battle begins in August, including a postcard campaign and a full-page ad in The Washington Post. American consumers, led by Congressman David King of Utah and the NDFA, ultimately beat it but it would keep resurfacing in various forms for the next 10 years.

J.I. Rodale’s The Complete Book of Vitamins is published.

1969
The FDA publishes proposed regulations for labeling and content of dietary supplements, however public opposition forces further hearings that last until the early 1970s.

The NHFA merges with the American Dietary Retailers Association (NDRA) and is now called the National Nutritional Foods Association (NNFA), which is announced at the 1970 show.

1970
The Chemical Feast: Ralph Nader’s Study Group Report on the Food and Drug Administration by James Turner is published.

Seeds of Change, the Green Revolution and Development in the 1970s by Lester R. Brown is published.

1971
Ruth Adams’ Say No! The New Pioneers Guide to Action to Save Our Environment is published.

1972
Sen. William Proxmire, a long-time health advocate, delivers the keynote address at the NNFA’s convention in Washington, D.C.

Rodale’s Complete Book of Minerals for Health is published.

1973
FDA publishes final regulations classifying any supplements with potencies above 150 percent of the RDAs as drugs.

Senator William Proxmire (D-Wis.) introduces S. 2801, called “The Food Supplement Amendment of 1973,” also called the Proxmire Amendment or the Vitamin Bill (which on the House side was H.R. 643, or the Hosmer Bill). This legislation is designed to prevent the FDA from classifying vitamins and minerals as drugs and to require the agency to regulate vitamins and minerals as foods or food supplements.

In support of H.R. 643, many experts and advocates give testimony, including: Dr. Annette Dickinson, Dr. Carlton Fredericks, Max Huberman, David King, Jim Turner, Esq., and Dr. Roger Williams.

The Council for Responsible Nutrition (CRN) is founded.

Dr. William Crook’s Your Child and Allergy is published.

Dr. Atkins’ Diet Revolution is published.

1974
Mega-Vitamin Therapy by Abram Hoffer, Frank Murray and Ruth Adams is published.

1975
Supernutrition: Megavitamin Revolution by Dr. Richard Passwater is published.

S. 548 [co-sponsored by Senators William Proxmire and Richard Schweiker (R-Penn.)], The Food Supplement Amendment of 1975, and Congressman William Randall’s H.R. 11247, are introduced to combat H.R. 16317 (an anti-supplement version of the Hosmer Bill), a newer version of the previously defeated Vitamin Volstead Act that would re-classify vitamins with potencies higher than 150 percent of the RDAs as drugs.

1976
On April 22, Pres. Gerald Ford signs the Heart and Lung Act, to which the Proxmire-Schweiker Vitamin Bill had been attached.

The NNFA---along with numerous champions, including Milton Bass, Max Huberman, Frank Murray and many others---fights against the devastating vitamin restrictions and ultimately wins. At the time, Max Huberman and Milton Bass write: “This landmark legislation is the greatest victory for the health food industry and consumer rights ever achieved.”

1978
Orthomolecular Nutrition by Abram Hoffer and Morton Walker is published.

1979
Cancer and Vitamin C by Drs. Ewan Cameron and Linus Pauling is published.

1980
Crooks’ Tracking Down Hidden Food Allergy is published.

1981
Dr. Atkins’ Nutrition Breakthrough is published.

1982
Brown’s Building A Sustainable Society is published by the Worldwatch Institute.

1983
Crook’s The Yeast Connection is published.

1984
More Than One Slingshot: How the Health Food Industry Is Changing America by Frank Murray is published by the    National Nutritional Foods Association.

1985
Carlton Fredericks’ New Low Blood Sugar and You is published.

1987
Fats That Heal, Fats That Kill by Udo Erasmus is introduced.

1989
Hoffer’s Orthomolecular Medicine for Physicians is published.

1990
President George H.W. Bush signs into law the Nutrition Labeling and Education Act (NLEA), which is intended to improve nutritional information regarding health claims made for products. The FDA is given the responsibility of implementing the law but, because of broad wording, the agency takes advantage of the opportunity to over-regulate nutritional supplements.

The Real Vitamin and Mineral Book by Dr. Shari Lieberman is published.

Prescription for Nutritional Healing by Phyllis Balch and Dr. James Balch is published.


1991
Passwater’s The New Supernutrition is published.

Crook’s Help for the Hyperactive Child is published.

Brown’s Saving the Planet: How to Shape An Environmentally Stable Global Economy is published by the Worldwatch Institute.

1992
The Health Freedom Act (S. 2835) is introduced by Sen. Orrin Hatch (R-Utah), legislation to protect the rights of American consumers to choose safe and effective dietary supplements. The basic principle of the bill was that supplements are not food additives, they aren’t drugs and they need to be defined.

The FDA had been using the food additives provisions in the law to go after supplements it did not like. In fact, in the early 1990s the FDA went on an enforcement rampage.

On May 6th, in what is today remembered as the Tahoma Clinic Raid, the FDA stormed Dr. Jonathan Wright’s clinic with armed sheriffs who terrorized patients and seized vitamins, equipment and medical records. Fear of similar abuse of power spread like wildfire across the U.S.

Joe Bassett and the northwest region of the NNFA expanded an early incarnation of Citizens for Health (CFH) in order to mobilize consumers and health-food stores against these threats.

Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and others.

1993
Meanwhile, industry champions such as Loren Israelsen, Milton Bass, Scott Bass (son of Milton Bass), Hal Drexler (of Country Life), Jarrow Rogovin (of Jarrow Formulas) and many others, were devoting considerable resources to the battle for DSHEA up to (and past) the 11th hour.
A dramatic public-service ad (PSA) was developed by director, Charles Abehsera, and aired nationally in December. In the ad, federal agents equipped in full Special Forces gear, including night vision and weapons, converge on Mel Gibson, in this now-famous cameo, who says, in defense as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

1994
Although the Democrats had a majority in the House and Senate, indicators were that the party was in danger of losing a number of seats in the 1994 election and the Democratic leadership was not eager to look like bad guys to the millions of Americans who supported the Hatch-Harkin-Richardson Bill (DSHEA), or S. 784.

Over the course of several hours, Senators Hatch, Kennedy, Harkin, Waxman and Congressman Dingell were able to hammer out a compromise bill. Between August 13 and October, both the Senate and House versions of DSHEA passed. Passage of DSHEA creates a new framework for regulation of dietary supplements.

At the time, Sen. Orrin Hatch comments: “I want to cite the dedicated efforts of Citizens for Health, whose thousands of members have worked tirelessly and unselfishly to make this an informed and successful debate. There is no question in my mind that the work of this citizen army makes today’s victory possible.”

Tales of A Shaman’s Apprentice by Dr. Mark J. Plotkin is published.

1995
Crook's The Yeast Connection and the Woman is published.

1996
The White House Commission on Dietary Supplement Labels issues its report on future regulation of this product category.

Hoffer’s Laws of Natural Nutrition is published.

1997
The USDA proposes its first version of Organic standards late this year. The CCOF, the Organic Trade Association and Citizens for Health are able to stop the U.S. Department of Agriculture (USDA) from debasing the definition of “organic.” Over a period of several months (into early 1998), nearly 300,000 communications were directed to the USDA protesting the proposal. The Secretary of Agriculture says, at the time, that this was the largest number of comments the Department has ever received on any proposed regulation. The FDA publishes industry regulations for structure/function claims that appear on supplement packaging and marketing materials.

Congress includes in the Food and Drug Modernization Act a provision allowing dietary supplements to make health claims.

Food Pets Die For (an exposé of the pet foods industry) is published by Ann N. Martin.

A second edition of Prescription for Nutritional Healing by Dr. James Balch and Phyllis Balch is introduced. 
 
1998
FDA inspectors arrive at the offices of a Texas-based stevia company to "witness destruction" of "offending" cookbooks featuring stevia, and other literature. A video camera taping the aborted destruction, and the intercession of Julian Whitaker, M.D. and Jim Turner prevented the book burning.

1999
The landmark case, Pearson v. Shalala (see related decision in 2001), was won, which finally forced the FDA to allow qualified health claims.

In March 1999, consumer and industry advocates successfully testify on Capitol Hill to oppose the FDA’s proposal to redefine disease to include life stages and normal discomforts, such as pregnancy, aging, menopause and headache.

FDA regulations require that a Supplement Facts panel appear on dietary supplement labels.

The NNFA rolls out a Good Manufacturing Practices (GMPs) program.

The Green Pharmacy by Dr. James Duke is published.

2000
Dr. Duke’s Essential Herbs is published.

2002
Dr. Atkins’ New Diet Revolution is published.

2004
Healing Cancer: Complementary Vitamin and Drug Treatments by Drs. Abram Hoffer and Linus Pauling is published.

2005
Despite a worldwide consumer backlash, Codex’ Draft Guidelines for Vitamin and Mineral Food Supplements are ratified and the European Food Supplements Directive (EFSD) is put in place.

2006
Largely thanks to several thousand letters sent to legislators through a consumer-industry coalition supporting its passage, the “AER bill” (The Dietary Supplement and Nonprescription Drug Consumer Protection Act”) clears through the U.S. House of Representatives at 3:06 am on December 9th, 2006.

2007
The FDA’s issues guidance on complementary and alternative medicine that could open the door to re-classifying common herbs and fruit/vegetable juices as “drugs” depending on their intended use. This is successfully opposed by Citizens for Health and many other advocacy organizations.

2008
In June, a three-year roll-out of the Federal cGMPs (current GMPs) for dietary supplements begins.

On April 17th, the FDA receives a Citizen Petition from a pharmaceutical company demanding that all weight-loss support claims be re-classified as disease claims, which was strongly condemned by consumers and natural products industry organizations.
Emord’s The Rise of Tyranny: How Federal Agencies Abuse Power and Pose Risks to Your Life and Liberty is published.

2009
In March, S. 510, the Food Safety Bill, is introduced by Sen. Richard Durbin (D-Ill.). Many consumer advocates and industry experts point out that S. 510 (which would cost Americans $825 billion in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which passed under suspended rules, do not address the root causes of the U.S.'s food safety problems and would hurt small growers and retailers.

2010
S. 3002, the Dietary Supplement Safety Act of 2010, is introduced by Sen. John McCain (R-Ariz.). Drafted to mainly address problems relating to athletes’ use of products spiked with drugs and illegal substances, the bill would do nothing to protect athletes or sports and would hurt health-food retailers, legitimate supplement makers and the American public without solving any problems.

After a massive grassroots letter-writing campaign led by Citizens for Health, the Alliance for Natural Health, and the Natural Products Association, on March 4th, Sen. Hatch submits a letter to Sen. McCain thanking him for withdrawing his support for parts of S. 3002.
On March 9th, Senators McCain and Dorgan submit a letter to Senators Harkin, Enzi and Hatch pledging to work with them in incorporating common-ground provisions into S. 510 (the Food Safety bill).

Dietary supplement cGMPs are now in place.

Brown’s World on the Edge: How to Prevent Environmental and Economic Collapse is published.

Health Freedom Nation: Consumers Take Control

By James J. Gormley
[Courtesy of NOW Foods]

Consumers and the health-food industry may have stopped S. 3002 in its tracks, but S. 510 and other threats to health freedom remain. Nevertheless, a new slate of bills, along with a re-invigorated health-freedom movement, offer new hope for the future.

Since the health-food movement’s earliest origins in New Hampshire in the 1790s, there have been many champions of health freedom.

The one who immediately springs to mind, at least for me, is Frank Murray, who happened to be my first boss before I became editor of Better Nutrition magazine in 1995.

In 2006, Frank was the recipient of the Natural Product Association (NPA) President’s Award for “long-time contributions to the natural products industry.”

He was for many years editor of Health Foods Retailing, the health-food industry’s very first trade publication and the official magazine of the NPA for 50 years, from the late-1930s until the mid-1980s.

More Than One Slingshot
A bestselling health-book author, Frank has been one of the industry’s most articulate, enthusiastic and tireless crusaders, having stood arm-in-arm with Milton Bass, Max Huberman and NPA in successful opposition to the Vitamin Volstead Act from 1966 through 1976, when the Proxmire Vitamin Bill was signed into law.

His book, More Than One Slingshot, which was written for the association, tells the history of the health food industry from its origins in the late 1890s up through the early 1980s.

The book has this great, dated cover that I love, one which depicts David and Goliath, a popular representation of the battle between the health-food industry and the U.S. Food and Drug Administration (FDA).

Today, in early 2010, we face many of the same threats to health freedom even if the names of the bills and the players have changed.

Today’s Threats to Health Freedom
In March of 2009, Sen. Richard Durbin (D-IL) introduced S. 510, the Food Safety Modernization Act, a bill that would hand over extensive, unwarranted powers to an agency, the FDA, that has shown that it cannot objectively and properly fulfill its mission regarding dietary supplements since it constantly works to undermine the Dietary Supplement Health and Education Act of 1994 (DSHEA) through coordinated suppression of supplement companies and health information regarding products sold by legitimate manufacturers.

As this bill was reviled by consumers and farmers across the country, it appeared to fall by the wayside, that is until Sen. John McCain introduced S. 3002, the Dietary Supplement Safety Act of 2010.

Senate Bill 3002 was said to be about athletics ─ trying to protect athletes from spiked or doped supplements (although one would think the athletes would know what they were taking, especially if they themselves ordered these products from shifty chemists and fly-by-night pharmacists), but it included a whole host of anti-supplement provisions that almost made S. 510 pale by comparison.

A firestorm of consumer outrage ensued: many tens of thousands of letters were sent to the Senate thanks to powerful grassroots advocacy campaigns organized by Citizens for Health, the Alliance for Natural Health and the NPA. In early March, Sen. McCain decided to withdraw his support of the bill, with the caveat that certain provisions should be carried over to S. 510, most of which are already in S. 510 as it now stands.

Consumers, and the natural products industry, must be especially vigilant now and throughout 2010 ─ regarding S. 510 so that the bad provisions in this bill are dropped or drastically revised, and that nothing even worse from the dry-docked S. 3002 winds up being added to S. 510.

Tomorrow’s Health Freedom Opportunities
As to bills that offer a ray of hope, there are currently three main ones: H.R. 4913, H.R. 3394 and H.R. 3395.

On March 23rd, Rep. Jason Chaffetz (R-Utah) and Rep. Jared Polis (D-CO) introduced the Free Speech about Science Act (H.R. 4913); since then, Rep. Dan Burton (R-Indiana) has signed on as a co-sponsor. The bill allows producers of healthy foods and dietary supplements to cite legitimate scientific studies on the health benefits of their products.

Similar in title to H.R. 4913, the Freedom of Health Speech Act (H.R. 3394), which was introduced by Rep. Ron Paul on July 29, 2009 and co-sponsored by Rep. Dan Burton and Dana Rohrabacher (R-Calif.), is geared to prevent the FTC from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes, based on clear and convincing evidence, that the statement made is false and that its communication causes harm to the public.

The Health Freedom Act (H.R. 3395) is designed to remove FDA's power of prior restraint over all nutrient-disease relationship claims.

According to Constitutional lawyer Jonathan Emord, under the bill “FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false.”

Gormley Take-Away: The powerful advocacy campaigns against S. 3002 (which generated tens of thousands of letters), in addition to meetings and conference calls with Sen. McCain and his staff, effected a partial yet still very important victory. The momentum and informed action that allowed consumers and the natural products industry to achieve this win must be maintained so that objectionable provisions of S. 510 are removed or drastically revised. Other bills that offer opportunities for informed action should be kept on our radar screens, including H.R. 4913, H.R. 3394 and H.R. 3395.

Orrin Hatch Letter to John McCain About S. 3002

This letter was sent by Senator Orrin Hatch, senior member of the HELP committee, to Senator John McCain on March 4, 2010, in large part as a result of the massively successful letter-writing campaign initiated by Citizens for Health and several other groups.
Please click here.http://www.citizens.org/?p=1984

Anti-Supplement “Perfect” Storm Building in Washington

http://www.citizens.org/?p=1924
By James J. Gormley

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trust has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.”

Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores.

NPA Alerts Health-Food Stores to Dangers of S. 3002

According to the Natural Products Association (NPA) in an e-mail alert issued today, here is how S. 3002 would affect health-food stores:

• All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.
• For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.
• Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.

Act now!

 

Take Action on S. 3002 Now!

To take action on Senate Bill 3002, please click on the poster below and act now!

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.

Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine or pseudoephedrine hydrochloride and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids
Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, 'roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called "pyramiding." With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

Legislation and Enforcement
On March 16th 2004, Joseph Rannazzisi, then deputy director of the DEA's Office of Diversion Control, said in testimony before the House Subcommittee on Crime, Terrorism and Homeland Security:

"The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically or pharmacologically related to testosterone. Because DEA’s authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction. H.R. 3866 [The Anabolic Steroid Control Act of 2004 ] will correct this problem."

Well, the Anabolic Steroid Control Act passed in October 2004. 

On the bill's passage, one of its sponsors, Sen. Orrin Hatch (R-UT), remarked:

"Under this bill, clever chemists will no longer be able to dodge the law by disguising their chemicals to skirt the legal definition of a steroid. Our bill gives the Drug Enforcement Agency the power to schedule nearly any steroid precursor now or in the future--giving the law flexibility we don't have to play catch-up with every new andro look-alike that comes along."

On September 29, 2009, the DEA's Rannazzsi, now deputy assistant administrator, said this in testimony before the Subcommittee on Crime and Drugs:

"Although DEA does not have the authority to enforce DSHEA [the Dietary Supplement Health and Education Act of 1994], DEA does have statutory authority to investigate incidents involving the illegal manufacture and distribution of anabolic adrenergic steroids in the dietary supplement market. [...] DEA has the authority and responsibility to investigate companies that are marketing products as dietary supplements that are adulterated with controlled substances."

As well the DEA should; if yogurt were suddenly used as a delivery vehicle for sports steroids, would our guardians of public health call for a new law restricting access to yogurt or would increased enforcement and enforcement funding be directed to the DEA to get the job done? The latter, I would think.

If supplements are being adulterated by illegal labs, why then should supplements get a bad rap? Steroids and sports doping is all about unethical pharmacies and illegal labs.

Case in point, in January 2009, a 198-count DEA indictment was unsealed charging 12 pharmacists and pharmacy owners with participating in a conspiracy that dispensed and sold thousands of dosages of anabolic steroids, including powerful veterinary steroids approved for animal use only.

Another case in point: in October 2009 the DEA announced the completion of a 10-month undercover investigation into an illegal anabolic steroid manufacturing ring that led to three arrests. In the raid, agents seized over 500 vials and 1,850 capsules of anabolic steroid pills.

While the U.S. Food and Drug Administration (FDA) has been involved in sweeps relating to the illegal sale of unapproved or misbranded drugs, such as the recent Internet sweep in November 2009 called the "International Internet Week of Action," many observers, including this commentator, strongly believe that all investigation and enforcement of sports doping and illegal steroid distribution and use should immediately be more clearly placed under the aegis of the DEA, as sports doping is not a problem of food products (such as supplements) but a problem of drugs---a problem of dope, pure and simple.

The Dietary Supplement Excuse

[With the DSSA bill, S. 3002, now up for vigorous debate, it's worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

By James J. Gormley

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

In the midst of all of this, in February 2003, Baltimore Orioles’ pitcher, Steve Bechler, died due to “a constellation of risk factors,” according to Broward County medical examiner, Dr. Joshua Perper, including: “being significantly overweight and not well conditioned”; “not yet being acclimatized to the warm climate of Florida” and “having hypertension and abnormal liver function.”

These extremely important facts were not mentioned at the time by Rep. Henry Waxman (D-CA) when he used this case as leverage for his anti-supplement intifada now, were they? In fact, according to April 2003 comments by attorneys Marc Ullman and Seth Flaum that were submitted to the FDA regarding the agency’s proposed rule for dietary supplements containing ephedra alkaloids:

“This information was left out of many of the news reports that followed Mr. Bechler’s death and has never been acknowledged by any FDA official.”

Picking up the doping follies again in December 2004, grand jury testimony appeared in the San Francisco Chronicle in which the paper said Bonds “admitted to unknowingly using steroids during the 2003 season. In July 2005, Conte pled guilty to steroid distribution and money laundering. Reports emerged in January 2007, said USA Today, that Bonds tested positive for amphetamines during the 2006 season.

"Oh, Those Tainted Dietary Supplements" or The Dietary Supplement Excuse
Which brings us back to the present, where we apparently have entered a new age, the age of "The Tainted Dietary Supplement Excuse," an excuse that almost anyone now who is caught improperly using spiked products cooked up in some lab can apparently take advantage of.

Many of these product abusers would have us believe that they are hapless fools, doe-eyed innocent pawns of diabolical masterminds who nefariously sabotage the benign nutritional products that are foisted upon them. Hardly.

Maybe we should suggest that users of heroin could claim that they used an opium poppy extract unknowingly tainted with morphine?

Perhaps people busted for cocaine possession could claim that the Erythroxylon shrub extract they were taking was tainted with cocaine alkaloids?

Who cares about athletes exercising personal responsibility and playing by the rules when stadiums are packed to the rafters and team (or even national) glory is at stake? Isn’t it that much easier for coaches or commissioners to look the other way when championship rings or gold medals are being handed out?

It’s not about dietary supplements but about greed, money, politics and power. The pharmaceutical lobby is very powerful. The money at stake behind sports is staggering. Our need for sports heroes is also very compelling.

America needs a scapegoat. How convenient that dietary supplements continue to be easy targets. Why don’t we blame pharmaceuticals? At least, we know they harm and kill people in droves.

Oh right—sorry. Forgot about all the pharma ads in newspapers, magazines and TV and their stranglehold on Congress and the FDA.

We’ll have to come up with another idea.

Food Safety for 2010: the Good, the Bad … and the Ugly

By James J. Gormley  
courtesy of NOW Foods
In October, we alerted you to serious worries about Senate Bill (S.) 510. Now that we have just started the New Year, let’s take a look back at the whole food safety picture in 2009 and how things are shaping up for 2010.

Here’s a partial run-down on some of the biggest food safety news stories of 2009:

1. Starting in January 2009, a giant peanut manufacturing corporation began voluntary recalls of up to 3,918 products made with peanut butter and peanut paste that reportedly caused nine deaths and 714 confirmed cases of Salmonella in 46 states.
2. In June and July of 2009, a fast-food restaurant in Milan, Illinois had two workers infected with hepatitis A working at the eatery; in addition to workers and customers getting sick, 10,000 people were exposed by the time the situation was under control.
3. Beginning in July (going through December), two mammoth meat manufacturers (based in Denver, Colo. and Fresno, Calif.) recalled 1.314 million pounds of beef due to concerns that it was contaminated with three strains of antibiotic-resistant Salmonella.
4. On September 1st, the Washington Post alerted us to the case of a Nevadan woman severely injured by chocolate-chip cookie dough contaminated with E. coli 0157:H7.
5. On October 4th the New York Times’ Michael Moss reported that a children’s dance instructor from Minnesota was partially paralyzed from E. coli 0157:H7 in hamburgers she ate. The meat originated in massive slaughterhouses in Nebraska, Texas, Uruguay, and a South Dakota firm that treats fat trimmings with ammonia to kill bacteria.
6. In December 2009, a series of articles in USA Today uncovered that Jack in the Box, Burger King and Costco are “are far more rigorous”─up to 10 times more stringent─ in checking for dangerous bacteria than is the USDA in setting standards for beef served to our children via the National School Lunch Program.

And lest these cases create the impression that contamination only relates to beef or peanut butter, ConsumerReports.org posted “The 10 riskiest foods overseen by the FDA,”  which lists the top ten offending foods. In decreasing order of “riskiness,” the article listed (somewhat surprisingly) the following 10 foods and food products: leafy greens; eggs; tuna; oysters; potatoes; cheese; ice cream; tomatoes; sprouts; and berries.

What do 2009’s food-safety outbreaks mean to us?
What the outbreaks in 2009 (and, for that matter over the last 19 years) mean is this: Food production by gargantuan factories and slaughterhouses is questionable; one marked by potentially unsanitary practices and stopgap remedial treatments that don’t work well .

As to food safety bills on Capitol Hill, here’s where things stand as of this writing:

• H.R. 759, or the Food and Drug Administration Globalization Act of 2009, sponsored by Congressman John Dingell (Mich.); 10 co-sponsors; introduced January 28th, 2009; referred to House Committee on Energy and Commerce on January 29, 2009.
• H.R. 875, or the Food Safety Modernization Act of 2009, sponsored by Congresswoman Rosa DeLauro (Conn.); 40 co-sponsors; introduced February 4th, 2009; referred to House Subcommittee on Livestock, Dairy and Poultry on April 23rd, 2009.
• H.R. 1332, or the Safe Food Enforcement, Assessment, Standards, and Targeting (FEAST) Act of 2009, sponsored by Congressman Jim Costa (Calif.); 30 co-sponsors; introduced March 5, 2009; executive comment requested from the FDA and the USDA on April 23rd, 2009.
• H.R. 2749, or the Food Safety Enhancement Act of 2009, sponsored by Congressman John Dingell; 5 co-sponsors; passed under suspended rules on July 30, 2009.
• Senate Bill (S.) 510, or the FDA Food Safety Modernization Act, sponsored by Senator Richard Durbin (Ill.); 15 co-sponsors; placed on Senate Legislative Calendar under General Orders (No. 247).

There are a couple of issues in these bills that stand out like sore thumbs. As to H.R. 875, this bill calls for the creation of yet another agency with another “czar”, the Food Safety Administration; not a welcome addition to fans of limited or more efficient government.

As to H.R. 2749, which passed the House already, this column has previously noted problems associated with this bill, including registration fees for food facilities and powers to “restrict the movement of food” by effectively quarantining (i.e., shutting down) a town, city or region. These aggressive new police powers should be reserved for demonstrable risks to public safety, not given freely as a blanket trust and authority granted to unelected agency bureaucrats.

On the positive side, thanks to grassroots advocacy organization new language in S. 510 exempts safe dietary supplements and organics while softening language relating to the threat of harmonization with Codex Alimentarius; however, there are still some areas of concern.

What will be the legislative fate of these bills?
Since H.R. 759 is considered the flagship House food-safety bill by Congresswoman DeLauro (who is the sponsor of H.R. 875, above) and since Congressman Dingell is the sponsor of H.R. 759 and of the House Bill which was last introduced but which passed first, I foresee two scenarios.

One strong probability is that all of the other House food-safety bills will fall by the wayside, since H.R. 2749 already passed and since S. 510 is likely to pass in the full Senate this year or early next.

A second possibility is that portions of H.R. 875 and 1332 will either make it into negotiations on the Senate side for S. 510─not very likely since H.R. 2749 has already passed─ or will be incorporated into this year’s agriculture appropriations bill, more likely since Congresswoman DeLauro was the sponsor of the 2009 “agriculture bill” that passed in October 2009.

Gormley Take-Away: Senate Bill 510 will likely be the “last man standing” in terms of food-safety bills in the remainder of this current 111th legislative session of Congress─ and perhaps in the first half of next year’s 112th session─and we do need to be vigilant on this bill before it becomes law.   Nevertheless, regardless of whatever food-safety bills are introduced or debated in 2010, we must push for increasing support of local food production (including food co-ops and community supported agriculture [CSA]). We also need food manufacturers to take more responsibility for ensuring the safety of the foods they produce by the use and enforcement of existing audited GMP and HACCP systems, backed up by testing. This will continue to keep the public safe and prevent Congress from setting up overly broad enforcement mechanisms without fixing the underlying problems.

Haiti: United Nations Appeal Launched for Emergency Assistance

Thousands of Pregnant Women at High Risk in Haiti

UNITED NATIONS, New York, 15 January 2010 — Estimates that there could be as many as 37,000 pregnant women among the 3 million people affected by Haiti’s earthquake have led to an urgent appeal to meet their emergency maternal health needs.

The earthquake has devastated Haiti’s health system and many of the hospitals and clinics in Port–Au-Prince have been damaged. The remaining can barely handle the thousands in need of medical care. The current situation is putting the lives of thousands of women and their infants at risk from complications related to pregnancy and child birth.

To meet the urgent maternal health and other needs of women, UNFPA, the United Nations Population Fund, is seeking about $4.6 million as part of the coordinated United Nations Flash Appeal that will be launched today. The funding would supplement the supplies UNFPA is already providing in Haiti and address the specific needs of women, girls and other vulnerable populations for the next six months. The additional funds would enable UNFPA to help:

• Refurbish maternity wards to handle emergency obstetric care and other life-saving health services;
• Deploy skilled health professionals, such as midwives, obstetricians and nurses, to affected areas to provide maternal health and emergency obstetric care;
• Provide emergency safe delivery and reproductive health medicines and supplies to temporary clinics and health facilities being set up;
• Help safeguard the personal hygiene and dignity of women and girls by providing related sanitary supplies;
• Facilitate access of affected populations, especially young people, to psychosocial counselling and other services; and
• Carry out interventions to prevent gender based violence.

For further information, please contact:
In Santo Domingo: Trygve Olfarnes, Tel: +507 301 7362, Satellite:
+ 898 8169 3160 0057 1740, olfarnes@unfpa.org.
In New York: Jessica Malter, Tel: + 1 212 297 5190, malter@unpfa.org
Omar Gharzeddine, Tel: + 1 212 297 5028 gharzeddine@unfpa.org
 

Save the Internet

By James J. Gormley

On behalf of Citizens for Health, an IRS-recognized not-for-profit organization with approximately 100,000 individual consumer members across the United States, I ask you to join with me and with FreePress in stating your strongest possible support for Net Neutrality (FCC Docket No. 09-191).

Visit this link: http://fjallfoss.fcc.gov/ecfs/hotdocket/list to file comments directly with the FCC. Once you are there scroll down (it should be near the top) to docket number 09-191 In the Matter of Preserving the Open Internet Broadband industry Practices. Once you click on the 09-191 it will shoot you to a page that already has all the docket details etc. this is the short form that you can use to easily file your comments.

The current Google censorship situation in China is a perfect example of why a 100 percent free and open Internet serves Americans and advances democracy.

Whether it is governments, corporations, advertisers or lobbyists (contributors), none of these groups should have any influence over a 100 percent free and open Internet that encourages the free-est possibly communication of ideas, opinions, facts, information, opportunities, and health information as well, whether it is health information about (or critical of) pharmaceuticals, diet, food, exercise, alternative medicine, herbalism, traditional healing traditions --- it should all be equally available and equally accessible to Americans.

Allowing Internet Service Providers (ISPs) the improper ability to slow down, hinder or block certain information (for example information that does not help their advertising partners) would be an outrageous and unacceptable violation of our Constitutional rights and would be wrong, unethical, anti-American and anti-democracy.

Filings by ISPs dare to suggest that this is about dictating to industry or assigning borders to an evolving medium --- that could not be further from the truth.

In point of fact, industry is attempting to gain greater control over what is, for now, a free highway of information and ideas; consumers are merely trying to protect this medium from telephone, wireless and cable companies’ efforts to turn this into an issue of virtual “eminent domain.” If these corporations and their lobbies are successful, it would make a mockery of this freedom and would not only violate article 17 of the Universal Declaration of Human Rights but would, as noted, violate the U.S. Constitution.

For all of these reasons, and many more, I, on behalf of the 100,000 members of Citizens for Health, ask you to call on the FCC to do the right thing: to pass strong and broad Net Neutrality rules.

Doing this will represent one of the most important regulatory protections any Federal agency can pass this decade, and perhaps even this century --- it will represent a legacy advancing democracy and protecting consumers for us, our children and future generations. 

Senate Bill 510: The $825 Million Dollar Folly

By James J. Gormley

courtesy of NOW Foods

Are you a backyard grower of heirloom tomatoes you sell on your own property or at a local farmer’s market? If so, you will be in for a whopper of a surprise if Senator Durbin’s Senate Bill 510 (S.B. 510) passes: you may be receiving a visit from inspectors.

Products not grown according to designated standards will be considered adulterated and your business records will be subject to warrantless searches by inspectors from the U.S. Food and Drug Administration (FDA), all this without any evidence that you have violated any law.

Wonder why the National Guard or Federal agents have effectively imposed martial law by quarantining your town? Under S.B. 510’s House counterpart bill, H.R. 2749 (Section 133b, “Authority to Prohibit or Restrict the Movement of Food”), sponsored by Congressman Dingell, the Secretary of Health and Human Services will have the power to prohibit all movement of all food within a geographic area, whether the food is in your grandmother’s grocery bag in her Toyota Hybrid or on a flatbed. No court order will be needed, just a phone call to the appropriate state official and a public announcement will be sufficient.

Upset that raw milk or raw milk cheeses (like feta) are no longer available in the U.S.? This could well happen thanks to the “performance standards” powers that would be granted to the FDA by S.B. 510, especially since the agency has made it clear that it is vehemently opposed to the consumption of raw milk products.

Amazed that U.S. food safety regulations strangely match those of other countries? Well, Section 306 of S.B. 510 would require “Recommendations to harmonize requirements under the Codex Alimentarius.”

And what about food supplement manufacturers, suppliers, distributors and health food stores? Will they be ensnared in this bill’s draconian, 1984-esque net? Very possibly so.

This all may seem far-fetched, but theoretically, this new law would give the government all this authority.

S.B. 510 (which would cost Americans $825 million in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which did pass under suspended rules, do not address the root causes of the U.S.'s food safety problems, which were highlighted in both a recent campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

According to Citizens for Health (http://www.citizens.org/), if this proposed law is enacted it would:

• Undermine DSHEA and move the U.S. one step closer to harmonizing our standards under Codex with those of supplement-restrictive regimes like the European Union. (DSHEA, or the Dietary Supplement Health and Education Act, asserts that supplements are food and are safe for consumption unless proven otherwise – ensuring that millions of Americans are able to enjoy access to safe, effective and affordable dietary supplements).

• Give the FDA unprecedented control over farms and direct-to-consumer distributors. If passed, the bills would charge facilities an annual $500 registration fee, require additional record keeping, and expand FDA authority to quarantine geographic areas for alleged food safety problems – all without significantly improving food safety.

• Cost U.S. taxpayers billions of dollars ($825 million in 2010 alone) while providing fewer physical inspections and less food safety overall.

• Harm U.S. organic farmers by imposing overlapping regulations.

• Hurt food supplements and health-food stores by imposing standards that are already covered by the AER (Adverse Event Reporting) Law, cGMPs (current Good Manufacturing Practices) and food facility registration.

• Cripple local food co-ops, farm stands, independent ranchers and artisanal food producers by imposing unnecessary standards and unfair bureaucratic burdens.

Clearly, S. 510, while purporting to increase food safety would actually leave consumers more vulnerable to foodborne disease since the FDA would be required to use a risky, risk-based food safety system rather than doing old-fashioned, effective physical, on-site inspections in plants, factory farms and slaughterhouses, where the actual food safety concerns are.

Furthermore, the U.S. has abrogated its duty to inspect and enforce food safety standards, both here and abroad, by allowing processing plants to regulate themselves under a failed system; and it has embraced policies that have driven independent U.S. farmers and ranchers out of business and replaced them with corporate-owned, industrialized food production units that are known to cut food safety corners to maximize corporate profits.

So what do we need to do?

Click here for an opportunity to send a letter opposing S.B. 510 as it is currently written.

Gormley Take Away: As of this writing, our nation is over $11.8 trillion in debt. Let’s not add $825 million more (actually several trillion dollar over the next few years) for a bureaucratic monster to be foisted upon an already deeply flawed U.S. food-safety system. S.B. 510 is sadly, and ironically, not about food safety, although I wish it were. It’s about food madness, pure and simple, and it must be fixed … or stopped.

Swine Flu: What To Do?

By Dr. Frank Lipman, Integrative Physician

Summer is over and the question I am being asked most frequently in my practice is, “what do I do about Swine flu?” My patients are wondering whether or not they should get vaccinated and the simple answer I give most of the time is ..NO!

From what you may have read, you might think that the swine flu vaccine is the answer to swine flu. Unfortunately this is not true and until we know that the vaccine is safe, I cannot in good conscience recommend it to most of my patients.

From the outset, let me say, I am not anti all vaccinations, rather I am pro vaccine safety and freedom of choice.

This is why am I not recommending the swine flu vaccine:

1) At this stage, for the most part the swine flu seems benign.

Over a million people in the US have already come down with swine flu, many of them without even knowing that they had it. The vast majority of people who get the swine flu recover after a week or so of high fever, aches, and respiratory distress. It’s not pleasant, but except in rare circumstances, it is not fatal. Most people who’ve been infected by swine flu think so little of it, they believe they just had a really bad cold or a regular flu. So unless the swine flu evolves to a much more virulent form, there’s no need for mass vaccination

2) We don’t know if the vaccine will be effective.

Vaccines are only useful against the specific viral strain that was available at the time of their manufacture. But influenza viruses mutate quickly, and as the WHO has already said, the real concern with H1N1 swine flu is that it will combine with seasonal flu in the Fall, creating a new strain that will of course be immune to all available vaccines.

3) We don’t know if the vaccine is safe.

The FDA has authorized an expedited approval process for the swine flu vaccine but we don’t know yet if it is safe. Even GlaxoSmithKline, one of the vaccine manufacturers has said, “The total population studied in clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.”

In other words, the only thing that is safe, is to say that no one knows. Since it’s never been used before and they have not had time to conduct any sufficient human testing, by getting vaccinated you are being a human guinea pig.

4) Vaccine manufacturers have been insulated from liability by the government.

The Department of Health and Human Services Secretary Kathleen Sibelius has granted legal immunity not only to the makers of the 2 drugs being used to treat swine flu, Tamiflu and Relenza, but also to the swine flu vaccine makers, for damages due to their use against swine flu. By effectively manipulating the legal system, the Pharmaceutical Industry through their powerful lobbyists have acquired almost complete and total insulation from any liability for their vaccines and adjuvants, which are additives added to generate a stronger immune response. It is believed that it is these adjuvants which often cause the problems. The last time the government embarked on a major vaccine campaign against a new swine flu was in 1976. Thousands filed claims for side effects such as paralysis caused by the vaccine and a number of people died. I am sure that the researchers know more now than they did last time and no one can say for certain that bad things will happen again or that you will suffer dire consequences if you get vaccinated. But this time you have no legal recourse even though this vaccine involves new factors, which makes it therefore experimental and unpredictable.

By shielding the manufacturers from any responsibility for any harm caused, the pharmaceutical firms have no financial incentive to make the safest product. In fact, they have a negative incentive to test it for safety, because if they are aware of problems, then they could potentially be held liable for willful misconduct.

Instead I advise my patients to build up and strengthen their immune systems to prevent viral infections.

Here are my top 10 recommendations:

1) Optimize your vitamin D levels.

Adequate levels of Vitamin D are essential for our immune systems to function optimally. Unfortunately there are no significant dietary sources of Vitamin D, most of our intake comes from exposure to sunlight. If you live far from the equator, you simply don’t get enough sun through Fall and Winter to make all the vitamin D you need. So unless you supplement during this period, your innate immunity will be compromised. Vitamin D plays such a crucial role in so many aspects of your body’s functioning, that supplementing with it makes sense whether you decide to get the flu shot or not.

We know that influenza always gets worse during the winter months. Now there is good evidence to suggest that this is because as sunlight hours lessen during the winter, the people living in the northern hemisphere become vitamin D deficient and are susceptible to influenza infections of all kinds. Here’s a great article available at NIH pertaining to this topic.

There is also some evidence that supplementation with a sufficient amount of vitamin D can help to prevent the onset of a flu or cold.

The current recommendations from the Food and Nutrition Board of the U.S. Institute of Medicine: from 200 to 600 IU/day depending on one’s age, are way too low. These values were originally chosen because they were found to prevent osteomalacia (bone softening) and rickets. It is now recognized that vitamin D has many additional physiological functions, for which these levels are totally inadequate. A number of scientists are therefore calling for the Food and Nutrition Board in the U.S. and its counterparts abroad to reassess their current recommendations.

To optimize your vit D levels, you will need to:
* Take at least 2,000 IU of a Vitamin D3 supplement daily.
* Get your 25 hydroxy Vitamin D level checked by your doctor (if that is not an option, you can self test your level with ZRT labs)

Although the current normal range is between 20 and 50ng/ml, this is much too low for optimal health. You want your level to be between 50 and 70ng/ml. This is the most important step you can take to prevent the flu!! It may require a number of months taking 5,000 to 10,000 IU of Vit D3 daily (especially during winter) under a doctor’s supervision, to optimize your blood level. Monitor your 25 hydroxy vitamin D status every 3 months until you are in the optimal range, then cut back to a maintenance dose of at least 2,000 IU a day.

2) Get adequate sleep, this is an indispensable requirement for a strong immune system.

3) Get adequate exercise, this keeps you robust.

4) Take actions to lower your stress levels.

Do breathing exercises, meditate, practice yoga, spend time doing something that makes you happy. Feeling spent, overwhelmed, and/or mentally run down has a causal relationship to your physical health.

5) Wash your hands frequently but not excessively.

It decreases your likelihood of spreading a virus to your nose, mouth or other people. Be sure you don’t use antibacterial soap because of the risk of creating resistant bacteria. Rather use a simple chemical-free soap.

6) Avoid sugar and processed foods as they decrease your immune function dramatically.

7) Eat phytonutrient rich meals (lots of colorful salads and dark greens)

8 ) Eat lots of garlic, it works as a broad spectrum antibiotic.

9) Take a probiotic daily (look for one with 10-20 billion organisms). A strong immune system relies heavily on having a strong foundation in the gut.

10) Keep a supply of antiviral herbal supplements on hand.

As opposed to antiviral drugs, antiviral herbs do not cause resistant strains because they are multifaceted and contain literally thousands of different medicinal compounds. Thus they are able to attack viruses with a full spectrum of synergistic substances. Andrographis, olive leaf extract, grapefruit seed extract and elderberry extract, all have antiviral properties. Use one or a combination of some of them as a prophylactic measure, for ex.whenever you travel (airports) or enter a potentially compromised environment such as a large office, auditorium, stadium, theater etc.

And if you really want to go all out, here are 4 more tips:

11) Take 1-2 grams (1,000-2,000 mg) of fish oils daily, its beneficial for immune function.

12) Take 2 grams (2,000 mg) of Vitamin C daily, yes it does help.

13) Stock your home pharmacy with an immune building formula. Look for one that contains Cordyceps and Astragulus. Take it throughout the flu season.

14) Keep homeopathic Oscillococcinum on hand

Take it at the earliest sign of a cold or flu. Early intervention is essential. If you are exposed to someone with the flu directly, you can take one dose twice a day for two days. You can also take one vial once a week throughout the winter, and two or three times a week during flu season, as a preventative measure.

Frank Lipman MD, is the founder and director of the Eleven Eleven Wellness Center in NYC a center whose emphasis is on preventive health care and patient education. His personal blend of Western and Eastern Medicine combined with the many other complimentary modalities he has studied, has helped thousands of people recover their energy and zest for life. He is the author of the recent SPENT: End Exhaustion and Feel Great Again (2009) and Total Renewal: 7 Key Steps to Resilience, Vitality and Long-Term Health (2003).

Lawmaking and the GAO Report: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?

Making the “Cut”: What the Latest Recall Tells us … and Doesn’t

By James J. Gormley

So we’ve all read the headlines about the recent recall of a line of 14 dietary supplements due to 23 reports of serious adverse events linked to (but not proved to caused by) the weight-loss and bodybuilding products in question.

The product recall that was requested by the U.S. Food and Drug Administration has been applauded by the natural products industry, as it shows how effective are the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the AER Law.

If truth be told, the manufacturer should have known better, regardless of where the final toxicology reports or class action lawsuits wind up, since a number of the recalled products were made with a modern version of the dangerous old “ECA stack” formula (ephedra-caffeine-aspirin, or ECA), with each serving containing stimulant herbs, over 400 mg of caffeine plus willow bark extract (natural aspirin).

That being said, the FDA, long believed to be a foe of the dietary supplements industry, is taking advantage of the recall to repeat its oft-voiced complaint that its hands are largely tied because it must rely on voluntary reports and post-market monitoring. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective and an isolated incident is often difficult to follow,” said the FDA’s Linda Katz, M.D., M.P.H.

Katz and the mainstream media are missing the point.

Dietary supplements, because they are a class of food products, are considered largely safe. Food products, and products derived from foods and plants, are presumed to be benign and have very little, often no known, side effects.

The ingredients in supplements are mainly natural ingredients that have co-evolved with humans from time immemorial and especially since the creation of agriculture 10,000 years ago.
They form what ethnobotanist Dr. Jim Duke refers to as the “Green Pharmacy” of healing and healthful compounds. When not used properly or used by profoundly unhealthy, often heavily medicated consumers looking for a quick fix, they are linked to a few hundred adverse event reports each year.

Drugs are largely synthetic, powerful chemical compounds that are not found in the food supply and which are presumed to be dangerous and often have very serious, known side effects.
Drug chemicals are primarily artificial compounds synthesized to dramatically change, stop, block or boost a system or process in the body in order to improve symptoms. They cause over 100,000 deaths a year and close to 1 million serious adverse events.

“Dietary supplements are not regulated as drugs because they are not drugs,” adds Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University.

According to David Seckman of the Natural Products Association (NPA), “This prompt action shows that the current DSHEA [law] works and that the adverse event reporting (AER) law that we helped to pass is working to enable the agencies to detect signals of any threat to public health. Thus, the industry is more than appropriately regulated and necessary consumer protections are in place.”

“They are regulated in exactly the same manner as all food and beverage products, including review of labeling claims, [post-market] surveillance, adverse event reporting, and so forth” agreed Blumberg. “The research base regarding most essential nutrients is more extensive than that of most drugs.”

Gormley Take-Away: DSHEA and the AER Law work very well. The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce. While consumers should not be scared about this rare product recall, some manufacturers (and these few companies know who they are) should take a hard look at their products and their safety and testing data to make sure they are not repeating mistakes of the past relating to formulas and claims, because nobody benefits from inadequate vigilance, the companies included.

One flu over the cuckoo’s nest? Phony Swine Flu products are dangerous

By James J. Gormley

“These are the times that try men’s souls.”
---“The Crisis” by Thomas Paine, December 23, 1776

As of May 17, 2009, 39 countries had officially reported 8,480 cases of “swine flu” (influenza A (H1N1) infection. Most confirmed cases were identified in Mexico (2,895 cases, 66 deaths) and the U.S. (4,714 cases, 4 deaths). The following states were hardest hit: Illinois (638 cases), Wisconsin (613), Texas (506), California (504), Arizona (435), Washington (246) and New York (242).

Although times of crisis, such as national health emergencies and global pandemics, bring out the best in most Americans, there have unfortunately always been some marketeers and hucksters who take advantage of the panic resulting from these tragic, and trying, times.

The current swine flu epidemic is no exception. On April 27th, 2009, within days of the first confirmed flu cases in the U.S., I received a press release announcing a nano-silver swine flu kit that was already being packed for shipment in “pre-paid overnight FEDEX boxes.”

I also received a “Swine Flu Alert” about a liquid silver supplement that allegedly “destroys MRSA, SARS, malaria, anthrax […] hepatitis C, HIV […] and bird flu.”

A day later, I stumbled upon an article posted on a Bulgarian news agency site with the following lead: “Bulgaria expects a huge increase in orders for two anti-flu dietary supplements in light of the current swine flu epidemic.” One of these products had already been the subject of a new dietary ingredient (NDI) rejection by the U.S. Food and Drug Administration (FDA) in early 2000.

On April 28th, I alerted Gary Coody to these scams; Gary is the national health fraud coordinator in the FDA’s Office of Enforcement. I also reached out to officials from the U.S. Federal Trade Commission (FTC).

Meanwhile, others in the natural products industry, including leading organizations, were quick to respond to these opportunistic peddlers. Industry responders included the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) --- which issued a joint press release, on May 1st, that included the following call-to-action:

“Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing swine flu.”

According to Michael Chappell, FDA’s acting associate commissioner for regulatory affairs, “In conjunction with the [FTC], the FDA has developed an aggressive strategy to identify, investigate and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

“Scam artists follow the headlines, trying to make a fast buck with products that play off the news --- and prey on concerned people,” said Eileen Harrington, acting director of the FTC’s Bureau of Consumer Protection. “We’re online and telling e-marketers their sites must comply with the law.”

The FTC has developed a new consumer alert, “Rx for Products That Claim to Prevent H1N1? A Healthy Dose of Skepticism” (http://ftc.gov/bcp/edu/pubs/consumer/alerts/alt083.shtm). It warns the public to be skeptical of claims that products like pills, air filtration devices and cleaning agents can supposedly kill or eliminate the virus.

This is, of course, not the first time that Internet peddlers have tried to take advantage of consumers during scares and epidemics.

By March 2002, the FTC had sent warning letters to 121 web sites selling products to “protect against, detect or treat illnesses caused by biological or chemical agents, including anthrax.” The products, most of them bogus or ineffective, included herbal remedies, air filters, gas masks and “do-it-yourself kits to test mail for anthrax.”

In 2005, the FDA issued warning letters to nine companies marketing phony avian flu products. The use of these fake products “increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t,” said the acting FDA commissioner on December 13th, 2005.

Gormley Take-Away: We should steer clear of any dietary supplements which claim to prevent, treat or cure swine flu --- and, for that matter, any virus or outbreak of any kind. Legitimate supplements, including herbals, are great for promoting health and helping us cope with the common, everyday nasties that come our way. But let’s leave the gas masks in the fallout shelters, okay?

How DSHEA Was Really Won

By James J. Gormley

DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law which protects our access to dietary supplements and to truthful information about them; it also provides for the quality and safety of supplements.

What led to the passage of this law was a historic grassroots and political battle, a struggle that actually had its roots in the early days of the modern health-food industry.

In 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA). This legislation was intended to improve nutritional information regarding health claims made for products. The FDA was given the job of implementing the law, but because of its broad wording, the agency began to capitalize on the opportunity to over-regulate safe and beneficial nutritional products.

In 1992, the Health Freedom Act was introduced in the Senate by Sen. Orrin Hatch, along with a similar bill in the House of Representatives, to protect the rights of U.S. citizens to choose safe and effective dietary supplements.

“The basic principle of the Health Freedom Act […] was that supplements aren’t food additives, they aren’t drugs and they need to be defined,” said Loren Israelsen, head of the LDI Group and the United Natural Products Alliance in Salt Lake City in a 2004 interview with Mitchell Clute in Natural Foods Merchandiser (NFM) that ran as a “10 years after DSHEA” anniversary article.

In an April 27th 2009 interview, Israelsen told The Gormley Files that “FDA began using the food additive provisions of the law as a tool to go after dietary supplements FDA did not like. This misuse of the law really ticked off a lot of people (me included).”

“The FDA Commissioner at that time, David Kessler, had commissioned a panel to study the question, ‘What should we do with supplements if we were to start afresh?”, noted Israelsen.

“Initially, FDA refused to make the report public. Ultimately, under pressure they did, and it confirmed our worst fears. Those are a few examples of the long fuse that burned up to 1992 when the first version of DSHEA called ‘The Health Freedom Act’ was introduced.”

The agency took the position that all supplements that did not have what it considered defined nutritional value were unapproved food additives. In this way, said industry attorney Marc Ullman, the FDA was able to keep many herbal supplements from American consumers. The FDA essentially went on an enforcement rampage.

The case that mobilized consumer opinion most against FDA was the Jonathan Wright case. Wright, a physician in Washington state, continued to prescribe L-tryptophan to his patients, knowing that while the U.S. had temporarily issued a ban on its sale as a dietary supplement, it had not explicitly banned its use for medical purposes.

On May 6th 1992, in what is today remembered as the Tahoma Clinic Raid, the FDA stormed Wright’s clinic with armed sheriffs who terrorized patients and seized vitamins, equipment and medical records. “The raid made no sense,” noted Israelsen. “There was no rational explanation. People began to think, ‘Wow, what are they prepared to do to stop us from taking vitamins.’ “

And this legitimate fear began to spread like wildfire across the country.

On the grassroots side, Joe Bassett and the northwest region of the Natural Products Association (or NPA, then NNFA) expanded an early incarnation of Citizens for Health (CFH) in order to mobilize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and others.

The American Botanical Council and the American Herbal Products Association (AHPA) were also important forces from the industry side.

Meanwhile, a dramatic public-service ad (PSA) was developed. In the ad, federal agents equipped in full Special Forces gear, including night vision and weapons, converge on Mel Gibson, in this now-famous cameo, who says, in defense as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

This call-to-action video (which was produced by noted Los Angeles-based producer/director, Back Home Pictures' Charles Abehsera and funded by an industry task force that included Patrick Mooney of California.-based Super Nutrition) warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”

Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?” While the video was a dramatization to be sure, it visualized a nightmarish scenario that was truly only one step away from reality at that time.

Another dramatic, and effective tactic used to educate consumers about the threats posed by the FDA’s efforts was the blackout day that was held.

Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store before DHSEA was passed.

“I vividly recall our putting on a ‘black out’ day. We got black mesh fabric and covered every product that would not be available for sale if DSHEA did not pass. It was nearly our entire supplement section! Products were available for sale but our staff was telling people why we had this restrictive covering […] and signage […] as well. Tables and chairs were set up for any customers who wanted to write a letter to Congress telling them how important access to dietary supplements was to them.”

Meanwhile, industry champions such as Loren Israelsen, Scott Bass (son of the late Milton Bass), Hal Drexler (of Country Life), Jarrow Rogovin (of Jarrow Formulas) and many others, were devoting considerable resources to the battle for DSHEA up to (and past) the 11th hour.

Although the Democrats had a majority in the House and Senate, indicators were that the party was in danger of losing a number of seats in the 1994 election and the Democratic leadership was not eager to look like bad guys to the millions of Americans who supported the Hatch-Harkin-Richardson Bill (DSHEA).

“Then a miracle happened,” Israelsen told NFM. Over the course of several hours, Senators Hatch, Kennedy, Harkin, Waxman and Congressman Dingell were able to hammer out a compromise bill.

“The bill never went through committee and was never voted on, contrary to popular myth,” said Israelsen in NFM. “It went from a zero, a nothing in the House to being a bill flying through by unanimous consent in the middle of the night. I think the FDA thought this bill would never pass and when it did they couldn’t believe it.”

“DSHEA was crafted in a very specific way to keep supplements within the confines of current food law and statutory interpretation,” Israelsen told The Gormley Files.

“There were a number of reasons this was done. We could have opted to make dietary supplements a separate category from foods and drugs. However, this would have left us with essentially no ‘software or hardware’ to deal with lots of issues for which we needed some framework and existing law.”

Although the story of how DSHEA was truly won is sometimes not told accurately, however, “Those who made a difference know what contributions they made,” noted Alex Schauss.

“They will always find satisfaction in having made a difference that influenced the course of history. Everyone made a difference. That’s the real story that hasn’t been told.”

The FDA: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally bankrupt diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) --- along with complementary and innovative industry self-regulatory programs --- consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends (emphasis mine): “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among many recommendations, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.” Aside from the fact that the number of adverse events directly attributed to dietary supplements would be trivial, in general, especially when compared to prescription and non-prescription drugs, the SAER Law already well protects consumers.

On top of this, the FDA doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

What I would argue is that why should America give more power and more money to an agency that is ill-equipped to handle, and undeserving of, either?

Here is a brief snapshot of an agency that is in chaos, completely mismanaged and rife with corruption:

• On September 20th, 2006, Sen. Chuck Grassley (R-IA)’s “oversight of the drug-safety agency” “exposed a “too-cozy relationship with the pharmaceutical drug industry and an agency culture that has sought to suppress concerns of agency scientists about drug safety reforms.” Grassley’s demand to the FDA pointed to violations of the public trust, including: “FDA’s suppression of scientific dissent and pressure to alter or exclude [negative] information” relating to drug approvals.

• On October 17th, 2006, the U.S. federal court (Case Number 06-438M) charged a now former FDA commissioner with conflict of interest and related offenses relating to undisclosed pharma connections.

• In November 2007, the Subcommittee on Science and Technology issued a damning report on the FDA entitled FDA Science and Mission at Risk. The report concluded, in part:
a. FDA’s evaluation methods have remained largely unchanged for the last half century.
b. FDA’s scientific workforce does not have sufficient capacity or capability.
c. The FDA has demonstrated a consistent inability to implement needed changes.
d. The recommendations of reviews of the FDA are seldom followed.

• Congressman Dingell --- a leading voice now demanding more resources for FDA --- back on November 17th, 2008, charged the agency with “mismanagement of agency resources” and launched an investigation into the “integrity of the Food and Drug Administration.”

• According to the non-profit group, the Project on Government Oversight (POGO) on February 18th, 2009, “Since 2006, the FDA is not ensuring that medical devices such as defibrillators, pacemakers, replacement heart valves and coronary stents are being tested according to good laboratory practices (GLPs).”

Fortunately, a number of far-sighted consumer organizations want to improve the FDA from its foundations, such as the American Association for Health Freedom, which is leading a campaign to reform the troubled agency.

Gormley Take-Away: Despite the grandstanding consumer-safety posturing from certain lawmakers suggesting that consumers are not protected from supplements, what we all desperately need protecting from is the FDA, itself, which, in its current state, is powerful, unresponsive, political, inept and corrupt. Should we perhaps establish an agency to shield us from the FDA? Better yet, let’s completely reform the agency from the bottom up, but let’s not give more power to an agency that already has more than it deserves to wield or give more resources to FDA until it proves it has (1) eliminated corruption and (2) knows how to better manage the resources (and authority) it already has.