Newsflash: Dietary Supplements Are Safe and Beneficial: Prescription Drugs Are Not!

By James J. Gormley

On August 23^rd, Newsday, a New York City newspaper ranked by Dr. Tim Groseclose as one of the top 61 most “liberal” local newspapers in the U.S. ran an article amazingly entitled, “FDA Official: 70% of Supplement Companies Violate Agency Rules.”

By “liberal” Groseclose did not mean the classical liberalism of a Thomas Jefferson or an Abraham Lincoln but the “big government,” nanny-state modern liberalism ushered in by Woodrow Wilson and expanded upon after 1921.

So perhaps we should not be completely surprised that any liberal paper would slant its coverage to support the unaccountable bureaucratic leviathan than the FDA is today ─ but, sadly, this does not serve the paper’s roughly 378,000 daily readers, readers who are, in large part, also consumers of dietary supplements ─ or at least they were before the above-cited “the sky is falling” article.

Dietary Supplements: The Real Story

Good Manufacturing Practices (GMPs) for dietary supplements are not new. The federal Current Good Manufacturing Practices for dietary supplements (21 CFR Part 111) were issued six years ago, and the Natural Products Association (NPA) rolled out its own voluntary GMP-certification program in 1999.

Contrary to the horror show of allegedly widespread incompetence, contamination and criminal negligence portrayed by the article, dietary supplements (a class of food products) are even more regulated than is food. According to whom, you ask?

How about the country’s most respected expert on food and drug law, attorney Peter Barton Hutt, who served as Chief Counsel for the FDA from 1971 to 1975, has taught food and drug law at Harvard for over 20 years, is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 3^rd edition 2007), and has published more than 175 book chapters and articles on food and drug law and also on health policy?

“The [Food Drug and Cosmetic Act], as amended by DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, provides somewhat greater FDA regulatory authority over dietary supplements than over conventional food,” noted Hutt in a white paper commissioned by the Council for Responsible Nutrition (CRN) entitled FDA Statutory Authority to Regulate the Safety of Dietary Supplements (2^nd edition, 2011).

Safety: The Facts

According to the Newsday article, approximately 6,300 adverse event reports were submitted for dietary supplements from 2008 to 2012, a 4-year period. 

Not even considering the fact that most of these reports were likely inaccurately linked to supplements when other factors were the more probable causes, in the same period Pharmaceutical Commerce reports that were approximately 3,260,000 adverse events reported for pharmaceutical drugs!

I don’t recall seeing this stark comparison in the newspaper article.

The FDA official quoted in the story, Daniel Fabricant, Ph.D., was formerly the science head for the NPA, and was a staunch defender of natural products until he became its chief critic at the FDA.

On August 26^th, John Spilateri Shaw, the CEO of Dr. Fabricant’s alma mater, the NPA, noted in an open letter to Newsday that “industry members strongly support providing additional resources for the FDA to keep illegal products disguised as legitimate supplements off the market.”

The vast majority of “supplements are beneficial, and millions of Americans depend on them each day,” Shaw added in his letter. “Your readers should continue to use these products that safely and positively influence their lives on a daily basis.”

Prescription and OTC Drugs: Safety? Not So Much

And what about the FDA takeover of three drug plants in 2011 following “shocking conditions” at the plants where one of the most popular line of over-the-counter (OTC) pain relievers (rhymes with “i-lenol”) were manufactured. "This inspection report is pretty close to being the worst I've seen,” according to David Lebo, a professor of pharmaceutical manufacturing at Temple University in Philadelphia, in an interview for CNNMoney.

The inspections reportedly uncovered safety and quality violations in every system, control and process, from bacterial contamination, to filthy manufacturing and storage conditions, to super-potent levels of pain relievers in batches of the infant pain-relief formula.

Didn’t see much media coverage of this, did you? I only noticed an obvious absence of the products from store shelves, and that was my first tip-off.

Hutt added: “DSHEA provides greater FDA scrutiny of new dietary ingredients than exists for new conventional food ingredients and adds new safety enforcement authority for all dietary supplements that extends beyond the FDA authority applicable to conventional food.”

Adulterated Supplements Are Illegal Drugs, Not Supplements

As to cases of deliberate adulteration of dietary supplements, if the ingredients were anabolic steroids, the product in question would then be an illegal drug ─ not a supplement ─ and it is subject to action by the U.S. Drug Enforcement Administration (DEA). I have been calling for the DEA to step up to the plate since 2010.

The same with deliberate contamination with weight-loss, sleep aid, or sexual health drugs, the rare number of cases of this type of adulteration also renders this type of hybrid product an illegal drug; it is no longer a dietary supplement product or issue.

As to even more rare cases of legitimate manufacturers who unwittingly receive and use shoddy, contaminated or adulterated raw materials due to falsified documentation and certifications, it is the manufacturer’s responsibility to ensure the purity and safety of the ingredients it uses, and there are multiple mechanisms in place to quarantine, test and verify ingredients before they are included in finished dietary supplement products.

Peter Barton Hutt's Takeaway on Supplement (Hyper) Regulation

“DSHEA adds three additional procedural safeguards for dietary supplement court actions to assure that FDA will act fairly and equitably in its enforcement of safety requirements, but does not substantially change the requirements applicable to court actions involving conventional food,” noted Hutt.

According to him, “The Dietary Supplement and Nonprescription Drug Consumer Protection Act expands FDA’s regulatory authority over dietary supplements by adding postmarket reporting and recordkeeping requirements that are more stringent than those that apply to conventional food.”

“Thus, in many ways, the current food safety provisions of the [Food Drug and Cosmetic Act] provide FDA with greater substantive authority over dietary supplements than they provide for conventional food, and the modest procedural changes in the court enforcement requirements have had no impact thus far and are unlikely to have a significant impact in the future,” Hutt concluded.

To counter the article’s misleading timeline with one that more accurately reflects the safety and consumer protections surrounding dietary supplements, I offer, by way of conclusion,  this one adapted from Peter Hutt's white paper:

• 1994: Congress enacted the Dietary Supplement Health and Education Act (DSHEA) to to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary ingredients.
• 2002: Congress enacted the Public Health Security and Bioterrorism Preparedness and Response to provide additional authority to assure the safety of the food supply. In 2006, Congress enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act to require mandatory adverse event reporting systems for dietary supplements.
• 2007: Congress enacted the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prohibit the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
• 2011: Congress enacted the FDA Food Safety Modernization Act (FSMA) to improve FDA’s capacity to prevent, detect, and respond to food safety problems.

In Memoriam: Joe Bassett, Health-Freedom Legend

In Memoriam: Joe Bassett, Health-Freedom Legend

Joseph M. Bassett

Joseph M. Bassett, the co-owner of two Bassett’s Health Food stores and a long time leader in the natural products industry, died on June 6th; he was 79 years old. According to his obituary, Bassett died of complications of a bladder and kidney infection.

He was a U.S. Army veteran who served honorably during the Korean War. Bassett and his wife Patricia started Bassett’s Health Foods in 1969, bringing vitamins and supplements to the Toledo, Ohio area. The retail outlet also offered a range of private label products, with formulas developed by Bassett using his knowledge of nutrition. He was trained and licensed in nutritional and massage therapies.

He was also vigorously involved in supporting consumer access to dietary supplements, actively participating as a member of the National Nutritional Foods Association (NNFA, now the Natural Products Association, or NPA).
More

The FDA's DMAA Gamble

By James J. Gormley
Senior Policy Advisor, Citizens for Health

Courtesy of the SupplySide Community

On April 24^th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of law and subject to seizure.

And, oh, by the way, since DMAA is a synthetic version of what may or may not be a constituent in geranium, it could not even be an NDI if it wanted to be, according to the FDA.

The FDA is resting its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA’s NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated.

Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C, alpha lipoic acid, and various amino acids.

In truth, DMAA is a constituent of the geranium (Pelargonium graveolens) plant, having been identified in the oil obtained from the steam distillation of the stems and leaves. This DMAA-containing plant has been used for centuries as a food item (e.g., leaves are infused for teas and added to desserts and confections, flowers are used in salads, while the oil has been used as a flavoring agent). In fact, the geranium plant and its oil are generally recognized as safe (GRAS). In terms of safety, GNC, for example, has sold 440 million servings of DMAA since 2007, with only one reported adverse event.

The FDA is following on the heels of the Defense Logistics Agency, which took products containing DMAA off military base shelves earlier this year based on two cases of death anecdotally linked to DMAA—despite the fact that the Pentagon has acknowledged no link between DMAA and the soldiers’ deaths.

On September 6^th, 2011, Barry Lynch from Cantox Health Sciences International issued an open memo in which he stated that not only do published data already exist (Ping et al., 1996) confirming that DMAA does occur in geranium oil, but also that USPlabs (the maker of Jack3d) has obtained new data “from two independent and highly respected analytical chemistry laboratories, utilizing advanced validated […] instrumentation and methods, [that] corroborate the original data published by Ping et al., and further demonstrate the occurrence of DMAA in the geranium plant […] and its edible oil.”

To be clear, the FDA is outrageously overstepping its bounds by using (although not overtly citing) non-binding opinion from a draft guidance document in Warning Letters in order to not only scare the named companies from using DMAA any longer but to also cause a widespread chilling effect in the marketplace where gun-shy companies preemptively pull an ingredient that is attracting the FDA’s attention rather than go to bat for it or join with other companies that are.

We see this happening already. Even companies that did not receive a Warning Letter are reformulating or have already reformulated their products into non-DMAA alternatives.

This is exactly what the FDA wants. Use inexpensive Warning Letters (as opposed to attempting to drag companies into Federal Court or to actually prove anything, which it cannot) to frighten the marketplace into “complying” with a version of the law that the Agency wished were in place but is not.

But no matter, if the industry decides that is much easier, and safer, to just sacrifice DMAA to avoid nasty letters from the FDA and to shield itself from frivolous class-action lawsuits citing non-binding Warning Letters, then it will have conceded defeat without a live bullet having even been fired.

And this is not to be critical of industry firms either, which honestly need to balance legal and regulatory exposure with the perceived or actual value of keeping a now-controversial ingredient in products, not to even mention public companies’ shareholder concerns and jittery insurance company worries.

That being said, the whole ugly mess reminds me of the early years in our current millennium when ephedra’s neck was on the proverbial chopping block. Many of us testified on behalf of this wonderful master botanical and tried to enlist the aid of an ephedra council from which the members had fled as if from a burning house---the San Diego ephedrine scandal did not help things, to put it mildly.

Now we have an ingredient on the chopping block.

It may not be a master herb with thousands of years of traditional use. It is not a full-spectrum botanical. And it has been included in some products whose marketing is not what we would hold up as a shining example of advertising probity and conservatism. But it does represent a line in the sand drawn by the FDA.

If we were to fully cave on DMAA, the FDA will use this as precedent for establishing a beach head on the shore of “nothing synthetic can be an NDI,” and then where will we be and what will we have gained---or lost?

The FDA’s Double-Barreled Shotgun Aimed at Dietary Supplements

By James J. Gormley

The Food and Drug Administration (FDA) plans to publish a proposed rule to revise the Nutrition Facts panel and related rules by the end of 2012.

According to Elaine Watson in Nutraingredients-usa.com, the FDA said it is “expected to look at serving sizes, daily values, adjustments to label formats and additional nutrient declarations, all of which have the potential to cause controversy.”

For example, if the FDA proposes that daily values be based on Estimated Average Requirements (EARs) instead of Recommended Dietary Allowances (RDAs) or Daily Reference Values (DVRs), the published dosage needed to achieve 100 percent of your daily value would drop dramatically, since EARs are significantly lower than are RDAs.

 
In essence, consumers might believe they are getting enough or a high-potency level of certain nutrients and forego purchasing or buying dietary supplements.

Suppliers of the country’s National School Lunch Program would probably be overjoyed since they could provide less nutritious foods to our kids and still “honor” their USDA contracts.

This new food-labeling scheme is reminiscent of the nutrient potency-labeling shenanigans that  preceded the Proxmire Vitamin Bill battle, albeit, in this case, attempting to dumb down foods while making them appear to  be more nutritious.

As Steve Mister and John Hathcock PhD (from the Council for Responsible Nutrition) wrote:

"In the early 1970s, FDA proposed to restrict the potency of vitamins and minerals in supplements to 150 percent of the Recommended Dietary Allowance (RDA); levels above that would automatically redefine a supplement as a drug and require the agency’s premarket approval. FDA ignored the fact that even some unfortified conventional foods can contain many multiples of the RDA for certain nutrients (e.g., vitamin B12 in liver) and thus be far more ‘potent’ than the vitamin supplements it sought to regulate. Consumers and the industry resisted, and Congress passed Section 411 (Rogers-Proxmire Amendment) to the Food, Drug and Cosmetic Act (FDCA), which specifies that FDA may not classify a supplement as a drug solely on the basis of potency."

The NDI Draft Guidance is engineered to gut, through misinterpretation, many of the most important features of the Dietary Supplement Health and Education Act of 1994 (1994), a law that was partly stimulated by FDA attempts to regulate dietary supplements as food additives, as Mister and Hathcock recently wrote in Nutritional Outlook magazine:

"Thwarted in that effort to call supplements unapproved new drugs [prior to Proxmire], FDA next attempted to classify dietary supplements as unapproved new food additives, thereby imposing on particular dietary ingredients the same requirements for premarket approval as applied to chemicals that were added to food for non-nutritive reasons.  [ ...] Congress then passed DSHEA, which states that dietary supplements shall not be regulated as food additives."

If the NDI Draft Guidance were to be finalized as written, and enforced along the same lines, many of the innovative dietary supplement products consumers use and rely on today would go the way of the dodo bird.
 
The Gormley Files Takeaway: Via two very different tacks, the FDA is attempting to overtly (in the case of the NDI Draft Guidance) and covertly (in the case of the food labeling scheme) roll back or undermine, respectively, the two biggest health-food-industry and consumer victories ever won against the FDA.

A Defining Moment for the Dietary Supplement Industry

By James J. Gormley

The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”

Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).

And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah), is alarmed by the Guidance.

Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.

Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.

War seldom is.

In 1966, the FDA announced plans that it was going to ban nutrient potencies over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.

When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender! No retreat!”

The battle cry was not “Let’s play nice,” of that I can assure you.

In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, and aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

And we won.

Offering an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.

So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome.Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”

Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.

“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”

Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?

Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?

They should.

When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.

We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.

For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833), and circulate these links via all of your lists.

Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.

Because that plate in front of them might well be empty.

What’s old is new again? The FDA takes aim at modern science and innovation

By James J. Gormley

On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.

What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ─ herbal extracts and nutrients ─ that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.

NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.

Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.

The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.

“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.

As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIs even though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”


The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”

In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”

What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

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.