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.

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.

The Food Safety Law: The Way Forward

By James J. Gormley

The biggest food-industry-related issue of the 2009-2010 Congress was S. 510/HR 2751, the Food Safety Modernization Act (FSMA or Public Law 111-353).

Advocacy and political positioning on the FSMA exemplified both successes that can be achieved via industry-consumer collaboration and yet, ultimately, likewise the failure of such a collaboration to achieve more than the political version of NIMBY (not in my back yard) accomplishments.

What trade groups failed to realize:

1. While the FSMA does provide some improved food-safety system measures, its over-reliance on recordkeeping and documentation that features a Hazard Analysis and Critical Control Point (HACCP) algorithmic/risk-based approach to food safety, and an under-reliance on on-site physical inspections, does nothing to address the core problems in this country’s food-safety system: filthy factory farms and disgusting slaughterhouses.
2. While these groups are patting each other on the back for being representatives of the regulated industry that have a “seat at the table,” their members’ raw material suppliers are being saddled with a dizzyingly complex and expensive system of paperwork and systems, onerous requirements whose impact is already being felt by companies that are attempting to be forward-compliant.
3. If the FDA abuses its now expanded powers, legitimate manufacturers (and classes of products) will be swept up in its allegations of adulteration, contamination and misbranding.
4. The organic trade groups will regret their effusive praise if raw milk and raw milk cheeses (a cottage industry and gourmet food segment) are taken off the market.
5. Although all trade groups claim that consumer benefit and consumer safety are at the very core of everything they support, including this law, they disregarded the fact that consumer health freedom organizations — groups which truly represent consumer interests — were completely opposed to S. 510 and HR 2751 and that tens of thousands of letters were sent to Congress demanding that this bill not pass in its current form (this is on top of over 20,000 letters to the White House calling for its veto).

Regardless, once trade groups and some conservative consumer groups saw that farms and dietary supplement finished products were ostensibly excluded from HR 2751, most parties claimed victory and applauded the bill’s passage despite the fact that very troubling provisions remain in the law, such as:

Reasonable probability and reasonable belief: According to Section 423, if there is a “reasonable probability” that an article of food is adulterated under section 402 or misbranded under section 403, the U.S. Food and Drug Administration will offer the manufacturer an “opportunity to cease distribution and recall such article.”

DANGER: The FDA has often called products misbranded based on the flimsiest of bases; it has also challenged the GRAS status of certain ingredients (or the data behind NDI filings) as a back-door attempt to go after certain combination supplements. The FDA has also made clear its regulatory animus regarding raw milk products (milk, cheeses). The FDA could very well attempt to use its expanded recall authority to effectively go on a “witch hunt” against certain products or classes or products that it cannot hurt through existing law.

Section 113 (new dietary ingredients) re anabolic steroids: One example of where dietary supplements were not totally excluded from HR 2751 is Section 113, wherein there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids, which could be excellent if judiciously applied — this was something I am pleased to note that I personally created a campaign on via Citizens for Health and various calls to action.
POTENTIAL DANGER: Nevertheless, the FDA merely needs to suspect that a supplement “may contain” an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement, which does open the door to potential targeting of legitimate manufacturers along with the fly-by-night operators.

Section 207. Administrative detention of food. In the final version of HR 2751, “credible evidence” was changed to “reason to believe” for suspected adulterated or contaminated food to be quarantined.

DANGER: Now the FDA does not even need credible evidence in order to impound food; all the agency needs to have is a gut feeling that food is dangerous, and it can be quarantined. While this might help in cases of intentional poisoning of the food supply, it does provide the FDA a great deal of additional discretionary authority.

Section 404. Compliance with International Agreements. Nothing in this act (or an amendment made by this act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g., General Agreement on Tariffs and Trade [GATT], NAFTA, the Uruguay Rounds, Codex).

DANGER: This is dangerous ground even if it was intended as a pro forma thruway. As an example of unintended, sovereignty-endangering consequences of nations including such language, one commentator claims that in Canada’s new Bill C-36, Health Canada has proposed that the powers provided to Parliament should be forfeited so that Canada can “honor its international agreements and commitments”! The FDA has not provided any explanation, much less a good reason, as to why sovereign U.S. domestic laws and regulations would need to be consistent, or not inconsistent, with international treaties and agreements.

Section 420. Limited distribution. “In the interest of national security, the Secretary of HHS, in consultation with the Secretary of Homeland Security, may determine the time, manner and form in which the guidance documents […] are made public, including by releasing such documents to targeted audiences.”

DANGER: If the U.S. government does not care to release the very instructions and guidance needed by suppliers and producers in order to properly comply with the requirements, the government does not have to, if cloaked under the usual catch-all blanket of “national security.” Obviously, in this way many food producers would likely fail if the requirements (and related compliance guidance) are a secret until inspection. This is similar to a teacher handing you a graded final exam despite the fact that you were denied the course, the textbook, the studying and the very exam questions themselves. Talk about setting food producer and ingredient suppliers up for failure!

The FSMA’s fate
Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.

The way forward

Effective health-freedom advocacy in 112th Congress. On the good side, the Republican-controlled House bodes well for anti-big-government, anti-big-spending, fiscally conservative efforts, including efforts to de-fund “Obamacare” (which will encounter stiff opposition in the Senate) and the FSMA (which is winnable).

One thing to keep in mind: Many old-school, good government Democrats vote anti-supplement because they honestly believe that, in so doing, they are protecting consumers. Some of the anti-supplement co-sponsors are also anti-GMO.

Therefore, approaches to the good-government Dems (called goo-goos) should not attack them as being anti-supplement but should, instead, make it clear that most measures which hurt consumer access to supplements and supplement information also hurts consumers themselves. We must drive home one of Benjamin Franklin’s many truths:

“The man who trades freedom for security does not deserve nor will he ever receive either.”