Earlier this year, President Obama signed the Food Safety Modernization Act (FMSA), which amends various portions of the United States Code relating to FDA’s powers to detain and regulate domestic and imported food products.  While the law was primarily drafted to grant the FDA some preventive measures to protect the American public from recent food scares (e.g., tainted peanut butter and eggs in 2009 and 2010 respectively), the language of the act will also have an effect on the dietary supplement industry.  However, the question is whether the FMSA, which will become effective on July 3, 2011, will have a material impact on the way most dietary supplement firms run their business.

Generally, the FMSA grants the FDA the authority to detain food products that it reasonably believes is adulterated for up to 30 days, and it also requires food importers to disclose whether their products were denied entrance in other countries.  While FDA’s expanded authority to detain foods is certainly material to the dietary supplement industry, the second rule is rather periphery unless a dietary supplement firm relies on imported food ingredients.  In addition to these two broader rules, the FMSA also amends some language in the Food, Drug & Cosmetic Act (FDCA) governing new dietary ingredients.  More specifically, the new law requires the FDA to notify the DEA whenever an application for a new dietary ingredient lacks sufficient substantiation proving that the ingredient is free from steroids or steroid analogs.

First, it is important to note that the FMSA lessens the burden of proof required by FDA to invoke its power under 21 U.S.C. 334(h)(1)(A) to detain adulterated food products from credible evidence to reasonable belief.  Whereas Black’s Law Dictionary defines the “credible evidence” standard as “evidence that is worthy of belief,” it also defines the “reasonable belief” standard as “to believe a given fact or combination of facts under circumstances in which a reasonable person would believe.”  Further, the “credible evidence” standard is generally considered a relatively easy burden to prove compared to other standards; however, under the FMSA, 21 U.S.C. 334(h)(1)(A) is abrogated to include an even lesser burden of proof standard.  Thus, if the FDA reasonably believes a given dietary supplement is adulterated—a catchall term that includes violations of the FDCA that range from relatively harmless violations such as improper structure and function claims to more egregious infractions such as the presence of harmful contaminants—the dietary supplement in question would be subject to federal detention for up to 30 days.

Second, section 113 of the FMSA also amends 21 U.S.C. 350b by adding the following language:

If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. (Emphasis added)

This provision is clearly designed to prevent the market and sale of unlawful steroid and steroid-analogs under the guise of dietary supplements.  While the language is putatively consistent with the Dietary Supplement Health & Education Act of 1994 (DSHEA) insofar that the burden rests with FDA in proving that a given ingredient does not comport with the law, it seems rather presumptuous to immediately conclude that the absence of documentation showing a dietary ingredient does not contain steroids or steroid analogs means it is, or contains, the steroid or steroid analog.

Nevertheless, the addition of these two new rules under the FMSA will likely affect the way dietary supplement firms operate their businesses, but it is unlikely that compliance with the FMSA will present the same challenges as CGMP compliance.  Yet, dietary supplement firms should be acutely conscious of the detention provision because the FDA is legally permitted to take proactive steps to detain products by satisfying a lesser burden (i.e., it is easier for the FDA to detain potentially adulterated products).  Coupled with the possibility of criminal sanctions under the Park Doctrine, dietary supplement firms should navigate the changing regulatory landscape cautiously and adopt super-adequate protocols that comport or exceed the requirements set forth in 21 C.F.R. 110 and 111.  Similarly, firms engaged in the manufacture, distribution, market, or sale of new dietary ingredients should take deliberate steps to dispel any suspicion that an ingredient is adulterated with steroid or steroid-analogs by submitting the necessary documentation.

Shafiel A. Karim earned a B.A. from California State University, Fullerton and an M.A. from California State University, Long Beach.  He is currently a J.D./M.B.A. candidate at Southwestern University School of Law and the Peter F. Drucker and Masatoshi Ito School of Management at Claremont Graduate University.

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As FDA continues to inspect dietary supplement manufacturers under the new CGMP framework, it is clear that many manufacturers share similar deficiencies.  Recent FDA warning letters show that many manufacturers are still struggling with structure function claims, the required pre- and post-production qualitative and quantitative testing requirements, and strong quality control units that have the necessary authority and resources needed to comport with CGMPs.  (See, e.g., here, here, here, here, here, and here.)  When coupled with recent administrative guidance suggesting FDA may resort to reprimanding non-complying firms under the Park Doctrine, which imposes strict criminal liability for non-compliance with CGMPs, it is imperative that dietary supplement firms understand the potential consequences arising from serious CGMP violations.

Indeed, last year FDA sent a letter to Senator Charles Grassley (R-IA) explaining its intention to reintroduce the possibility of imposing criminal charges for misdemeanor violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”) under the Parks Doctrine.  The Park Doctrine imposes strict liability, which means that the violating firm’s senior management need not have intent or knowledge of the violations to be found guilty.  Therefore, given FDA’s publicly stated intention of imposing harsher punishments for CGMP non-compliance, are future violations similar to those recorded thus far likely to result in criminal sanctions under the Park Doctrine?

The Park Doctrine is derived from United States v. Park, 421 U.S. 628 (1975), a landmark case decided by the Supreme Court.  In Parks, the president of Acme Markets, Inc., a large national food retailer, was convicted of violating sections of FFDCA for failing to sufficiently rectify unsanitary conditions at some of Acme’s warehouses, and for allowing adulterated food to be distributed in interstate commerce.  The Court reasoned that “[t]he requirements of foresight and vigilance imposed on responsible corporate agents are beyond question demanding, and perhaps onerous, but they are no more stringent than the public has a right to expect of those who voluntarily assume positions of authority in business enterprises whose services and products affect the health and well-being of the public that supports them.” Parks, 421 U.S. at 672.  A dietary supplement is considered adulterated if it is prepared, packed or held in conditions that do not comply with CGMPs, or if it contain poisonous or unsafe ingredients.  21 U.S.C.A. 342.

While FDA has enumerated several “serious” violations of FFDCA during routine CGMP audits, the severity of the violations found do not necessarily pose a serious public health risk as seen in Parks.  For example, FDA’s recent warning letter to Gaspari Nutrition cites several deficiencies in the company’s customer complaint recording procedures.  While the absence of customer complaint recordation procedures may (substantially) delay the recall of an adulterated dietary supplement product that poses a public health risk, it is not aconduct that is necessarily an imminent public health risk.

In fact, the majority of violations found in dietary supplement firms—as recorded in FDA’s published warning letters—stem from a lack of documentation, validation, or pre- and post-production testing.  In Parks, however, the violations were more obviously deleterious; FDA inspectors found chronic rodent infestations in some of Acme’s warehouses.  However, this is not to say that deficiencies in documentation, validation, and testing cannot result in the manufacture or distribution of dietary supplements that pose a public health risk.  On the contrary, such deficiencies may simply be telltale indicators of more substantive public health risks.  For example, if a dietary supplement firm cannot confirm the identity or purity of an ingredient through documentation, it is logically plausible to conclude that the dietary supplement may contain ingredients that are injurious to public health.

Dietary supplements that are processed in operations that do not comport with CGMPs are more likely to be contaminated by virtue of the fact that such operations lack the necessary infrastructure and procedural controls necessary to prevent cross-contamination and adulteration.  Smaller dietary supplement firms are less likely to have made the necessary investments in air handling and water purification systems, both of which are potential sources of adulteration.  If a cleaning procedure is not validated though quantitative testing, how can the manufacturer verify that the equipment has been sufficiently cleaned to prevent potential microbial growth or product cross-contamination?  To be sure, firms that lack validated operating procedures risk improperly cleaning equipment and facilities without sufficiently eliminating the potential for adulteration.

Despite these deficiencies, anecdotal consensus suggests that any future Parks Doctrine enforcement will stem from gross violations of FFDCA and CGMPs that are so pervasive that they pose a substantial and imminent risk to public health.  And, using Parks’ factual circumstances as a guide, habitual or repeated violations will likely be a prerequisite for a Parks Doctrine prosecution.  From a procedural vantage, if FDA intends to pursue criminal sanctions under the Park Doctrine, it must notify its Office of Criminal Investigations accordingly, which is then required to conduct further due diligence.  Unfortunately, FDA has not supplied a bright-line rule articulating what kinds of violations will warrant criminal sanctions.  Instead, firms are left with a series of factors, which includes repeated violations and illegal conduct, inter alia.

Although the likelihood of FDA imposing criminal sanctions to owners and senior decision-makers of dietary supplement firms for minor violations of CGMPs is unlikely, repeated violations that engender public health risks will certainly be candidates for the draconian consequences that arise from the Parks Doctrine.  Accordingly, it is in the dietary supplement industry’s best interest to adopt super-adequate quality control and quality assurance protocols.  Instead of waiting for FDA’s inexorable audit, dietary supplement firms should be conducting regular internal audits to ensure compliance with CGMPs and other relevant regulatory rules.  Such measures will engender good will with consumers of dietary supplement products as well as government agencies.

Shafiel A. Karim earned a B.A. from California State University, Fullerton and an M.A. from California State University, Long Beach.  He is currently a J.D./M.B.A. candidate at Southwestern University School of Law and the Peter F. Drucker and Masatoshi Ito School of Management at Claremont Graduate University.

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The purpose of the letter is stated as to “address the significant public health problems posed by products that are marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.”

The letter states that the FDA has received numerous reports of serious adverse events associated with consumer use of those FDA-approved ingredients, which are generally undeclared in the labeling, that are being included in dietary supplements without warning to consumers. These adverse events include strokes, acute liver injury, kidney failure, pulmonary embolisms and death.

The FDA has been investigating supplements in order to discover whether or not they include ingredients that are deemed to be FDA-approved drugs. The areas in which the FDA found the highest rate of products marketed as dietary supplements but containing hidden ingredients include products for weight loss, sexual enhancement and body building. This includes a recall of more than 70 products marketed for sexual enhancement, 40 products marketed for weight loss and more than 80 products marketed for body building.

Although warning letters and recalls have been the primary source of action by the FDA, the letter states that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act and endanger the public. The letter makes sure to point out that individuals, not just companies, can also be brought up on charges when it states “Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted under the Act.”

The FDA’s recommendation in this letter is that all firms that manufacture, import, distribute, or sell dietary supplements understand and investigate their full supply chain and review their manufacturing and quality assurance activities to ensure the lawfulness, quality and safety of their products. The FDA also encourages the industry to report any suspected tainted supplements and has offered an anonymous reporting method.

The FDA is hoping that this letter is spread widely throughout the industry in order to eradicate the use of chemicals regulated as drugs in nutritional supplements. It is also seeking continued input from people within the industry to help strategize a way to combat this problem.

To read the letter, click here.

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To understand why Sen. John McCain introduced a bill on dietary supplements, read the press releases. The legislation announced Feb. 3  addresses public safety, but mostly it’s about the reputation and revenue of professional and Olympic sports.

The evidence: McCain says in the release that “a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy.  Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.”

McCain ends the release, “It is my hope that this legislation will ensure that all Americans, including athletes, have all the information necessary to make informed decision when choosing whether to use a dietary supplement, and that the FDA has the ability to remove any harmful dietary supplements from the market.”

What organization was first to endorse the legislation? Major League Baseball. Commissioner Bud Selig issued a statement supporting the bill and MLB.com reported on McCain’s announcement of the legislation.

Next on board: The U.S. Anti-Doping Agency, which issued a press release with an affiliated group, Supplement Safety Now. Its members include Major League Baseball, NFL, NBA, NHL, PGA, NCAA and other national sports organizations. All are powerful organizations inside and outside Washington. And they share a complaint: Their athletes have been unwitting victims of mislabeled supplements that caused disqualifications and suspensions.

In other words, the products were bad for business. The groups want to arm the FDA with the data to monitor supplements and the power to yank immediately the detrimental ones off the shelf. They found an ally in McCain, whose 2008 presidential campaign received substantial financial support from athletes and others in pro sports, ESPN reports.

The initial response from groups representing supplement makers and marketers was tepid. “Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” Michael McGuffin, president of the American Herbal Products Association said the third paragraph of a press release.

The last sentence of the third paragraph of a press release from the Council for Responsible Nutrition quotes CEO Steve Mister as saying, “The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions.”

As the bill moves from the headlines to the sidelines, look for an intense lobbying effort by sports organizations. Supplement-related scandals have hurt their reputations and wallets. They see a solution in increased federal action and will push hard for that.

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On the topic of the FDA and regulation of dietary supplements, I am quoted as saying:

“The fear was a Democratic administration was going to be 180-degrees different…But the measures taken have not approached the sort of draconian response a lot of folks in the industry feared.  That’s not to say things didn’t tighten, they did.”

David Ettinger Food Law Expert

Also quoted is food law expert (and college chum) David Ettinger of Keller and Heckman in DC.

Unfortunately, the link requires a subscription, but a 30 day trial is available.  To read the full article, click here.

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David Frum

David Frum recently laid into the nutritional supplement industry with a guest commentary on CNN.com. The resident fellow at the American Enterprise Institute and one-time special assistant to President George W. Bush lashed out with the classic invectives against supplement makers and marketers. He wrote that any “snake oil flim-flam can be huckstered in the most truth-defying way” using that most evil of laws, the Dietary Supplement Health and Education Act of 1994.

Frum could have lowered his rhetorical blood pressure, without the help of a supplement, by reading the FTC regulations that go into effect on Tuesday. His column then would have begun: The party is over Dec. 1.

And the party — or at least marketing as it has been done for many years — does come to an end. Frum’s arguments against vague product claims no longer hold when the FTC — not the FDA — is watching what is said. The effects of the new rules are worth noting again: no more CYA disclaimers such as “results not typical” language; closer scrutiny of expert and celebrity endorsements; and careful review of consumer testimonials.

All the people who try a supplement and blog about it or are paid to write online reviews also have to disclose their relationships with those who supply them with products.

Frum can argue for repeal of the DHSEA, but he would be better off passing along tips of deceptive advertising to contacts he has at the FTC. That would produce more effective results than spouting off about his distaste for the supplement industry and its marketing practices.

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Ric Hobby - VP Govt. & Industry Affairs, Herbalife Europe

Ric Hobby spoke at the CRN Conference last week on the state of international supplement regulation with a particular focus on European regulatory efforts.  Ric directed most of his talk on the work of the International Alliance of Dietary/Food Supplement Associations, of which CRN is a member.

The three European issues where IADSA has been most involved are:
* Maximum levels of vitamins and minerals
* Claims
* Botanicals
Ric referred to the “claims” issue as a “raving nightmare.”  The claims process requires review and approval for all claims by the European Foods Safety Authority.  Under the current process even “established” claims for supplements are being rejected by EFSA.

Ric also highlighted IADSA’s popular publications it produces and distributes including a very useful one entitled “The Scientific Substantiation of Health Claims” featured here.  You can download the guide by clicking on it.

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David Vladeck - FTC Director of Consumer Protection

David Vladeck, Director of the Federal Trade Commission Bureau of Consumer Protection spoke at the Council for Responsible Nutrition Conference on the FTC’s “active” dietary supplement enforcement agenda.

Dir. Vladeck began by highlighting recent FTC enforcement actions against bogus cancer cures, Airborne generics,  fake hoodia, and peddlers of H1N1 flu cures.  Vladeck noted that FTC has begun sending joint warning letters with FDA to marketers of bogus H1N1 flu products.

Vladeck had good words to say about the NAD as well. Though Vladeck observed that FTC did not always agree with NAD, which is a departure from the attitude taken by prior Consumer Protection Division directors.

Then Vladeck turned to the new FTC Endorsement Guides.  Everyone held their breath.

Before I go further it is important to remember that Vladeck comes from a consumer protection background.   He led the Public Citizen Litigation Group for 20+ years.

On the endorsement guides Vladeck’s message was clear:

1. Disclaimers like “results not typical” are useless and will be attacked by FTC.

2. Advertisers who make claims “will be held responsible for their claims.”

3. If your promotion relies only on testimonials “you will have a problem with us.”

Vladeck described this area for the FTC as a “target rich enviornment” in which they intend to pursue violators using all the resources at their disposal.  And when the 1000+ enforcement personnel at the FTC run out, FTC plans to call on the state attorneys’ general.  When the AG’s are too busy, Vladeck says that they will do as the FDA does and publish warning letters on the internet in order to “bully companies into compliance.”

Despite the backpeddling FTC has done in the media recently, Vladeck made it clear that he will enforce Section 5 of the Federal Trade Commission Act and the endorsement guides.  It was as if Vladeck was drawing imaginary targets on foreheads around the room…

I spoke to several attorneys and CEOs at the reception that evening about the regulatory problem the enforcement guides present and everyone agreed that the problem is very serious.  One observed, candidly, that the problem was that “you never know what marketing is doing until it is too late.”

After all, lawyers and regulatory execs are considered “sales killers.”  We are never consulted by marketing in advance of a promotion for fear we will put the kibosh on the latest profitable social media marketing strategy.

So what’s next from the FTC?  Who knows.  After all, it’s a “target rich environment.”

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FDA Deputy Commissioner Joshua Sharfstein, M.D.

FDA Principal Deputy Commissioner Joshua M. Sharfstein, M.D. gave the keynote speech to the Council for Responsible Nutrition Conference. Dr. Sharfstein expressed a willingness to work with supplement industry members and received a warm welcome from industry members in return.

Sharfstein filled in at the last minute when Commissioner Margaret Hamburg, M.D. was called before the Senate Committee on Health, Labor, Education and Pensions to testify at a hearing entitled “Keeping America’s Families Safe: Reforming the Food Safety System.”

Dr. Sharfstein started off by noting that FDA products account for $.20 of every $1.00 spent by Americans.  As to supplements, he revealed that he (like me) suffers from lactose intolerance and supplements with lactase enzyme.

Beyond the pleasantries, Sharfstein focused his speech on regulatory concerns with specific types of products and what FDA is doing currently to address these concerns.  Sharfstein pointed specifically to FDA successes in addressing products promoted for treating H1N1 flu, adulterated muscle enhancers containing anabolic steroids, and male enhancement supplements containing erectile dysfunction drug analogues.

Sharfstein also addressed suggestions that one way regulate adulterated supplements is through the NDI process.  Under DSHEA, ingredients that were in the food supply prior to October of 1994 are grandfathered in, but those that were not and require new dietary ingredient (NDI) applications.  However, as Sharfstein noted, there is no FDA recognized list of grandfathered supplement ingredients at present, and also many supplement products often contain undeclared ingredients which makes an approach that depends upon examining labels fundamentally flawed.  As a result, Sharfstein declared that new ingredient premarket verification is a priority for FDA.  With these and other challenges Sharfstein expressed a sincere willingness to work with industry to improve FDA response and regulatory strategies.

Sharfstein did receive several probing questions including a challenge regarding the FDA’s handling of the recent Hydroxycut recall, something we at NutriSupLaw have previously questioned several times.  The questioner noted that Hydroxycut was recalled based upon just 23 reports of liver disease out of over 20 million units of Hydroxycut sold, and asked Sharfstein for a the scientific basis of the FDA’s action.  The questioner also noted that the panel that raised concerns with Hydroxycut failed to identify a specific ingredient in the product that caused the problems, and there are many products still on the market today that contain those same ingredients.

To his credit, Sharfstein did not simply “toe the party line” on this issue in his response.  Instead he observed “I am getting the sense that there is a lack of understanding in this room about why the FDA did this,” and he went on to suggest that FDA reevaluate the matter and hold a conference call with industry to discuss it further.

Let’s see if FDA comes through and works with industry on these efforts.

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New Rules: Endorsements & Testimonials in Marketing (The Business of Marketing)

“Those were the days – the days when a marketer could use an actual quote from a real person that has used your product as a marketing endorsement or testimonial to capture the aspirations of your potential customers. As of December 1, 2009, those days are gone.”

What You Need to Know About the New FTC Endorsement Rules — and Why (Ad Age)

“Revlon won’t be able to give away its product to mommy bloggers without asking them to disclose it in their writings. And if Jennifer Love Hewitt claims her blemish-free skin is the result of Proactiv, she had better be telling the truth.”

FTC Wants To Clarify: Bloggers Probably Won’t Get Dinged $11,000 (Washington Post)

“…the FTC would most likely send an [sic] warning letter to a blogger who pitches for Jiffy but doesn’t disclose receiving funds from Virginia peanut farmers.”

Do the FTC’s New Endorsement/Testimonial Rules Violate 47 USC 230? (Technology & Marketing Law blog)

“…the FTC apparently has made the same analytical error that the SEC recently made in the SEC’s proposal to hold securities issuers liable for third party content they link to.”

FTC Orders More Disclosure in Consumer Testimonials, Celebrity Endorsements (National Law Journal)

“(Attorney Anthony DiResta is) not as positively inclined toward the decision to do away with the “results may vary” disclaimer in favor of describing typical results. “Whenever there is going to be a claim of typicality, then there’s going to have to be substantiation.” And that can be costly and timely, DiResta added.”

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