The FDA's Record on Slimming Products: Weighing In

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

Considering the U.S. Food and Drug Administration’s (FDA) record as a flibbertigibbet on weight-loss product enforcement (dragging its feet on ephedrine for years while green-lighting dangerous weight-loss drugs on a dime) — and in light of the FTC’s record of multimillion dollar fines and orders against makers of supplement weight-loss products — for any company to enter this arena, either with a proprietary slimming ingredient or with a finished product, it is a minefield out there. Witness warning letters sent by the FDA to makers of HCG diet products.

Despite (or due to) the aforementioned spotty record, it is hard to fathom an FDA agency advisory committee’s recent green light for a combo of phentermine and topiramate (Qnexa), a diet pill that has, according to the Alliance for Natural Health, “documented risks of causing birth defects and heart problems.”

Abdominal Cramps Anyone?

On January 24, 1996, the FDA approved the synthetic fat-substitute, olestra, for use in snacks. But would you want a product with this warning? “This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients.”

Anal leakage is most certainly not on my “hit parade” of things I am looking for in a snack beverage, or any product for that matter!

According to an update by Center for Science in the Public Interest (CSPI), “Olestra is a moribund, if not totally dead, product.” No surprise there.

A few years later, in March 1999, consumer and industry advocates successfully testified 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.

The FTC Steps Into the Breach

On November 9, 2004, the Federal Trade Commission (FTC) launched “Operation Big Fat Lie,” what it billed as “a nation-wide law enforcement sweep against […] companies making false weight-loss claims in national advertisements.”

According to the FTC at the time: “Operation Big Fat Lie is the latest in the Commission’s efforts to: stop deceptive advertising and provide refunds to consumers harmed by unscrupulous weight-loss advertisers; encourage media outlets not to carry advertisements containing bogus weight-loss claims; and educate consumers to be on their guard against companies promising miraculous weight loss without diet or exercise.”

Agreed, although the FDA’s track record on weight-loss products in all categories has not helped American consumers very much, either.

Alley-oop!

In 2006, GSK applied to get its drug (orlistat) — which was said, at the time, by the group Public Citizen, to have a history of side effects and gastrointestinal problems — re-classified as an OTC weight loss drug called alli™.

Shades of olestra, Public Citizen’s objections cited such embarrassing product usage problems as anal leakage and such serious problems as pre-cancerous lesions. On February 7, 2007, the FDA dismissed the group’s well -argued petition, saying that the product label already warns people about the messy bowel problems.

As to those pesky pre-cancerous cellular changes allegedly caused by the drug (called “aberrant crypt foci”), the FDA said they aren’t of “clinical significance.”

Interesting, because according to the NIH National Cancer Institute, aberrant crypt foci represent “one of the earliest changes that can be seen in the colon that may lead to cancer.”

But, then again, FDA’s approvals were being called into question — institutional arrogance can’t allow that — and a powerful drug maker’s products were also being questioned.

Still dead set on the weight-loss market, on April 17, 2008, GSK and groups it funds submitted a Citizen Petition (FDA-2008-P-0248-0001) calling for the FDA to reclassify all weight loss support claims for dietary supplements as disease claims.

GSK was joined in this petition by the American Dietetic Association, the Obesity Society, and Shaping America’s Health. The organizations’ signatories included a lobbyist, a person who helped get obesity classified as a disease and a fundraising guru.

In the petition’s summary, GSK and its co-petitioners stated: “Moreover, the actions requested in this petition would help address concerns about the safety of weight loss supplements” and “By requiring weight-loss supplements to undergo pre-market review, FDA would shift the burden to manufacturers to show that their products are safe.”

What about the potential safety problems related to GSK’s alli? This product went through both a prescription drug and (an albeit cursory) OTC safety review process and it still has a number of reported concerns associated with it.

Takeaway: Allowing questionable weight-loss drugs and prohibiting legitimate claims for dietary supplements that assist people in achieving body composition and weight-loss goals provides Big Pharma an El Dorado, like the legendary lost city of gold, and cheats consumers out of safe, effective products while exposing them to unwarranted risk.

‘Supplements Are Safe, Healthful and Well-Regulated’!

By James J. Gormley

On March 25th, 1999, I was part of a live television debate on FOX-TV’s “Good Day New York” with a drug industry attorney on the topic: “Are dietary supplements regulated?”(1)

Needless to say, with all of the facts showing how well regulated dietary supplements were then, winning the debate was not a difficult accomplishment; I even had the host, Jim Ryan, on the side of supplement consumers about midway through the segment.

In fact, the regulations and laws governing nutritional supplements in 2011 are even more stringent than they were in 1999, when I did that show.

According to attorney Peter Barton Hutt, the “bedrock food safety requirement that has been the foundation of the American food supply since 1906 — the prohibition of poisonous or deleterious substances in food—applies equally to dietary supplements and conventional food” (2).

Supplements: A Super-Regulated Category
Today, dietary supplements have the following requirements and controls over them:

• Pre-market notification to the U.S. Food and Drug Administration (FDA)—not required for drugs or medical devices.
• Labeling.
• Mandatory adverse event (side effect or reaction) reporting to the FDA (not required for foods).
• FDA Good Manufacturing Practices (GMPs).
• Facility registration (for the FDA).
• Advertising (by the U.S. Federal Trade Commission).

In fact, broadly speaking, the laws governing supplements under the umbrella of the Food Drug and Cosmetic Act (FD and C) are: the Nutrition Labeling and Education Act of 1990 (NLEA); the Dietary Supplement Health and Education Act of 1994 (DSHEA); the Bioterrorism Act of 2002; the Food Allergen Labeling an Consumer Protection Act of 2004; the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 (AER Law); and Federal GMPs.

Regarding dietary supplements, the FDA has significant powers, including (but not limited to) the authority to:

• Stop a company from selling any dietary supplement that is unsanitary or unsafe.
• Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling.
• Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury.”
• Block a new dietary ingredient (NDI) from being marketed if the agency does not receive enough safety information in advance.

Likewise, the FTC has a great deal of surveillance and enforcement powers that it uses for dietary supplements, including the ability to: challenge and stop advertising that is not sufficiently substantiated; negotiate a consent order for a company to change or fix its promotional, marketing or advertising practices; and to seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders. 

So Why Do We Keep Hearing About Supplements Being Unregulated?
Part of the problem is the media.
As I noted way back in 1999 (1), despite powerful and authoritative research underpinning many of the most popular supplements today, the mainstream media appear to be on a planet where this research is unavailable or incomprehensible.

The FDA itself has also been stoking the misinformation fires about the supplement regulations that it is mandated to implement and enforce. As I noted in July 2009, “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” (3).

Dietary supplements have “always been regulated as a category of food in this country, and DSHEA did not change that,” according to the Council for Responsible Nutrition (CRN) (4).

“Dietary supplements are not regulated as drugs because they are not drugs,” added Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University (3).

According to Hutt, it is “apparent that FDA has adequate statutory authority to assure the safety of both dietary ingredients and conventional food ingredients” (2).

In fact, Hutt adds that the “safety provisions under the FD and C Act applicable to dietary supplements would appear to be stronger than those applicable to conventional food.”

‘Supplements Are Safe, Healthful and Well-Regulated’ may not be a very “sexy” story title as they go, but it is one that really should be front-page news.

Gormley Take-Away: Given all of the recent drug recalls and food contamination outbreaks, I would be much more concerned about the safety of pharmaceuticals and conventional foods than about dietary supplements if I were the average consumer advocate, legislator or reporter. Looking at the powerful safety record of dietary supplements, now officially demonstrated via the AER Law, I would consider beating a different drum than the one associated with unwarranted and uninformed attacks on supplements.

REFERENCES
1. Gormley J. Mass media is unregulated [Editor’s Desk]. Better Nutrition. August 1999.
2. Hutt PB. FDA Statutory Authority to Regulate The Safety of Dietary Supplements [White Paper]. Covington and Burling, June 6, 2003.
3. Gormley J. Making the ‘cut’: What the latest recall tells us … and doesn’t. The Gormley Files. July 21, 2009.
4. Council for Responsible Nutrition. Dietary supplements: Safe, beneficial and regulated. Revised December 2009. Accessible at: http://www.crnusa.org/CRNRegQandA.html

A New Year’s Resolution: We Will Make Our Voices Heard in 2011!

By James J. Gormley

Courtesy of NOW Foods

The late William F. Buckley, Jr. ─ yes, the William F. Buckley of Firing Line, The National Review and the editorial column “On the Right” ─ once wrote:
 

“We are all increasingly anxious in America to be unobtrusive, we are reluctant to make our voices heard, hesitant about claiming our right; we are afraid that our cause is unjust, or that if it is not unjust, that it is ambiguous; or if not even that, that it is too trivial to justify the horrors of a confrontation with Authority; we will sit in an oven or endure a racking headache before undertaking a head-on, I'm-here-to-tell-you complaint.”

In addition to being hesitant to speak up about issues that are important to us ─ such as challenges to health and health-freedom on Capitol Hill ─ very often people do not know how to start or where to start in order to tackle these issues.

Here are a few of the main reasons why people don’t take action on health-freedom issues (including battles relating to dietary supplements):

1. They are not even aware of the issue.
2. They are aware of the issue, but they are not sure the source (organization or website) from which they learned of the issue is credible or well informed.
3. They are aware of the issue, and they are sure of the source, but they don’t know what the next step to take is, whether it is a phone call to a town, city, county, state or U.S. elected official.
4. They are aware of the all of the above, but they assume that “other people” will call in or write or act, so they don’t have to because others are presumably already taking action.

NEW YEAR’S RESOLUTION NO. 1:

I WILL BE AWARE OF THE ISSUES

It is our responsibility as health conscious consumers and natural products advocates to regularly visit the websites and blogs of those organizations that are the most credible (more on this in resolution number 2 and the Gormley Take-Away, below), to sign up for e-newsletters and regular updates, and to friend or “like” those organizations on Facebook and Twitter. Join these organizations’ discussion groups, and regularly participate in posting comments on issues and posts. Ask questions, learn, ask more questions. Soon you will be a super-informed advocate.

NEW YEAR’S RESOLUTION NO. 2:
I WILL GET MY INFORMATION FROM HEALTH-FREEDOM ORGANIZATIONS THAT ARE CREDIBLE AND EFFECTIVE

Aside from organizations that are shills for big money interests in one segment of industry ─ not common, to begin with, and less likely now given stricter FCC rules re blogs ─ most health-advocacy and health-freedom organizations are well-meaning although not necessarily well informed. Sometimes a health-freedom group will intentionally use scare tactics to get consumers activated on a specific issue or campaign, never a good or ethical approach. If an organization consistently (or constantly) sends out “The sky is falling” announcements and calls to action, this group may be non-credible and not trustworthy.

I remember one group’s representative with whom I sat down at the July 2005 Codex meeting in Rome coming out with a press release (and e-mail blast) saying: “All supplements are now banned!!!” I challenged the person about this after I saw the blast go out and asked why his group said that, knowing full well that this is not at all what went down. He said that his organization thought it was important to get people activated! (I assume to donate money to an emergency “battle” fund). So be selective as to which groups you get your information from, especially if they are also always asking you to donate money and are always in “crisis mode.”

RESOLUTION NO. 3:
I WILL CONSIDER TAKING INFORMED, CONSTRUCTIVE ACTION ON ISSUES AFFECTING ME, MY FAMILY, MY COMMUNITY AND MY COUNTRY

If we are linked in to credible health advocacy organizations, most likely they will regularly recommend specific actions, which will typically involve reading an issue summary and then submitting on online letter (or petition signature) to elected officials related to the question at issue. Typically, by filling out an online form with one’s Zip code and other contact information, the correct officials’ names will be automatically generated. However, another way to verify who your legislators are (at the state and national level) is to visit USA.gov. For non-elected officials (such as at the FDA or FTC), you can contact the agencies directly.

RESOLUTION NO. 4:
I WILL NOT ASSUME THAT OTHERS WILL TAKE ACTION BUT WILL TAKE ACTION MYSELF ON IMPORTANT ISSUES IN 2011
Just as with voting, being an informed, active and participatory citizen is essential to protecting and advancing democracy. As Mr. Buckley sagely noted, we must be obtrusive, we must be committed and we must be assured in claiming our rights. By being knowledgeable and informed about the issues, we do not need to worry about our message or our cause being construed as ambiguous. We must question “Authority” since authority is merely power lent to agencies and officials to carry out the public will and to fulfill the public good.

Gormley Take-Away:

Some reputable organizations to consider finding out more about include (but are not limited to):
Alliance for Natural Health/AAHF
Citizens for Health
Citizens Speaking Out for Health
National Health Federation
Organic Consumers Association

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.

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?

What if there were no law protecting our supplements?

A public-service ad that first aired in December 1993 showed camouflaged Federal agents equipped in full Special Forces gear, including night vision and weapons converging on Mel Gibson, who says, in defense, as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

Before DSHEA
This call-to-action video (which was produced by noted Los Angeles-based producer/director, Charles Abehsera) 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 dystopian U.S. society that was truly only one step away from reality at that time.

This ad, together with many other coordinated grassroots efforts, created a groundswell of support for what would become the Dietary Supplement Health and Education Act of 1994, or DSHEA, the law that today protects our access to dietary supplements and to information about these products.

In the 1990s, however, the marketplace and the regulatory landscapes were quite different from today’s. In some ways, the enforcement climate had reverted to that of the days before the Proxmire Vitamin Bill (The Food Supplement Amendment of 1973).

The FDA: an agency on the warpath
Raids, perhaps not as dramatic as the one with Mel Gibson but scary nonetheless, were not uncommon occurrences before DSHEA.

“Although FDA [the U.S. Food and Drug Administration] had been carrying out raids against health-food stores and alternative medicine clinics around the country to harass the supplement industry, when the Health Freedom Act of 1992 was introduced---which became DSHEA---ethical supplement companies knew that there was an uneven playing field on which unethical companies were selling products that did not meet label claims for content or purity and who were making untruthful and misleading health claims for their products,” said Alex Schauss, Ph.D., managing director of AIBMR Life Sciences.

In the 1990s, Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store. He described the countrywide “black out” day this way: “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.”

How, then, did we go from our victory in the mid-1970s with the Vitamin Bill to the anti-supplement climate of the 1990s?

Annette Dickinson, Ph.D., a noted supplement industry expert, told it to me this way: “In the early 1990s, FDA, under then-commissioner David Kessler, was on a path toward restricting the availability of dietary supplements.

“In 1993, FDA published a [notice] outlining concepts put forward by the famous ‘Dykstra committee’ suggesting that limits should be placed on vitamins and minerals (perhaps at a few multiples of the RDA), that amino acids were unapproved food additives when used in supplements, and that botanicals […] were inherently […] drug-like and possibly unsafe.”

Mark Blumenthal, the head of the American Botanical Council

agreed: “The Dykstra Report was one of the primary motivators for industry groups that [propelled] industry […] to propose and support Sen. Orrin Hatch’s Health Freedom Act in 1992 which, the next year, was revised and introduced into the Senate as DSHEA.”

Health-freedom advocate and commentator, Elissa Meininger, said that, “Among the events that led up to the passage of DSHEA was the publication of the

FDA’s Task Force Report on Dietary Supplements. In it, there was a statement that I saw as a smoking gun. It stated that the presence of dietary supplements on the market represented a ‘disincentive’ (the FDA’s word) for patented drug research.”

A world without DSHEA
“Without DSHEA,” said Scott Tips, attorney and National Health Federation counsel, “there would be far more single-ingredient supplements at lower potencies, less innovation and the FDA would be able to squeeze far more than it can now any ‘non-compliant’ companies with fines and compliance actions. The thousands of new products that have hit the supplement market since […] DSHEA would have been a trickle instead.”

In many ways, our country would be similar to Europe minus the natural medicine tradition. I have heard from a number of health-freedom advocates across the Atlantic who have to shop in pharmacies for their supplements, supplements for which they often require prescriptions. High-potency (read: American) supplements are hidden behind the counter and are sold to people only upon request, and on the “QT” at that. Sounds like a black market, doesn’t it?

“Because the American people will not be swayed from their supplements, it is likely that a black market of supplements would have [arisen],” observed Beth Clay, senior vice president at Capitol Strategy Consultants. That’s what it would be like here, in the U.S., without DSHEA. But this black market would come at a price – without the controls such as Good Manufacturing Practices, FDA guidance on labeling and structure function claims, FTC guidance on truth in advertising, and Adverse Event reporting procedures. This would make for a return to the “snake oil” days of the early part of the century.

Now we have had a glimpse of what our country, and our dietary supplement choices, would look like without DSHEA. In what ways is DSHEA better?

“I think one of the biggest differences from the pre-DSHEA time period is that DSHEA really helped ‘legitimize’ the dietary supplement industry in the minds of many consumers, as it set down specific rules and regulations that manufacturers had to follow in order to be in compliance with DSHEA, such as labeling standards,” noted Daniel McSweeney, owner and president of Vitamin Retailer Magazine Inc.

Gormley Take-Away: So although we must feel fortunate that DSHEA exists, we must remember that the price of liberty is eternal vigilance. In recent years, the Federal Trade Commission (FTC) has picked up where the FDA left off and, by its numerous enforcement actions, “threatens to diminish the industry’s inventiveness for new products that could benefit and support consumer health,” warned Schauss.