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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Irwin Naturals, one of the nation’s leading suppliers of natural dietary and herbal supplements, announces that it has reached a settlement with a California task force that named seven of its hundreds of products as being mislabeled or falsely advertised according to California law. The company has resolved all issues raised in the investigation.

The task force alleged that several Irwin products did not carry the proper lead warning label as required by California’s unique Proposition 65 law, but not that any of them contained an unsafe amount of lead. No product recall was or will be instituted as a result of the settlement, and no products were reformulated in response.

Proposition 65 requires a warning label for any product that contains an identifiable amount of a chemical or heavy metal on a daily dose basis. However, according to Prop. 65, the level of lead at which a product is considered unsafe is about 28 times greater than the level at which a warning on a label is required. As a result, Prop. 65 warnings have become ubiquitous throughout California on everything from wine bottles to Disneyland.

“We stand by our products, as we have for 15 years, and this settlement acknowledges that our products are safe and that we are in compliance with California laws,” said company spokesperson Rebecca Pearman. “As a trusted name in the nutritional supplement business, we are committed to best industry practices in manufacturing, quality assurance and labeling to ensure the quality and safety of our products and our continued leadership position in the industry.”

The task force also alleged that their tests failed to find Hoodia in some of the company’s products labeled as containing the herb. However, the company could not confirm these findings because no validated test method exists for identifying Hoodia in the softgel product form used by the company. The company relied instead on the industry standard method of confirming the input of Hoodia, and all manufacturing records confirmed that Hoodia had been put in to the products. The investigation did not result in either a product recall or reformulation.

Pearman said that while the company does not agree that it intentionally mislabeled or falsely advertised its products, it has no dispute with the task force’s fundamental objective to bring greater oversight to the nutritional supplement industry.

“For more than 15 years, we have staunchly supported the evolving standards under which our industry operates,” said Pearman. “California has some of the most stringent labeling laws in the nation, and in complying with those, we will continue to strive to meet or exceed all national requirements for our industry.”

Unrelated to the labeling claims was an allegation that the company failed to refund consumers who met the company’s refund policy. The task force did not identify specific complaints or consumers, but the company has set up a limited restitution fund. Consumers with questions about eligibility for refunds under the settlement can call the company at (800) 941-9098.

For the official announcement and more contact info on Irwin Naturals please visit 24-7 press release.

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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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Following up on a post from June 30, the question of consumer confidence in nutritional supplements arises again. The Times-Herald reports that many supplements have quality problems.  No one knows just how many of 40,000 products underdeliver on the goods listed their labels and over-deliver on unlisted, harmful ingredients and contaminants. “I believe that the problem is narrow, that the well-established and reputable brands deserve their reputations,” Michael McGuffin, president of the American Herbal Products Association, tells the paper that serves the Hudson Valley of New York.

The article then reels off test results that indicate a much broader problem:  “In ConsumerLab.com tests, six out of nine chondroitin supplements failed testing in April 2007. One had only 8 percent of what it claimed to contain, and one ‘maximum strength’ product had none.”

How big will the elephant become before the people in the room acknowledge its presence? And who will act first: manufacturers, regulators, consumers, Congress, a state attorney general, or a sharp civil attorney? And which company will be hounded out of existence as an example to others in the industry?

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Companies keen on product development will likely get a boost from the compromise version of the stimulus bill that the House was set to vote on Friday. There are billions of dollars for government research grants and millions for construction of research buildings. The final legislation did pull back in areas such as agriculture. Here are the highlights, according to Inside Higher Ed:

• National Science Foundation: $3 billion, including $2.5 billion for research, $400 million for infrastructure and $100 million for education.
• National Institutes of Health: $10 billion, including $8.5 billion for research and $1.5 billion for university research facilities.
• National Institute of Standards and Technology: $180 million for competitive grants for research building construction.
• Energy Department: $2 billion for research, including $1.6 billion for Office of Science, $400 million for Advanced Research Project Agency-Energy; no money for infrastructure.

For a perspective on what the funds could mean for research, read or listen to this NPR report. Another view comes from a blog at The Scientist under the headline, “NIH wins stimulus jackpot.” Because there are so many versions of the bill, read it here in PDF format.

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Research at Yale

Nestled in the $800 billion-plus economic stimulus bills that Congress is considering are billions of dollars for non-profit research centers, universities and possibly private firms. The Chronicle of Higher Education breaks down the House and Senate bills into categories that range from NSF to NIH. The monies present opportunities for private and non-profit firms that understand how to tap into the funding.

Here are some of the particulars:

• National Science Foundation:  House bill (in XML format) bill — $2 billion for research grants, $900 million for equipment and facilities, and $100 million for science education; Senate bill (available by searching the PDF) — $1.2 billion for research grants, $150 million for infrastructure, $50 million for education.
• National Institutes for Health: House — $1.5 billion for biomedical research, $2 billion for facilities renovation and capacity building; $2.7 billion for biomedical research; $300 million for shared equipment.
• Agriculture Department Cooperative State Research, Education and Economic Service: House — no money; Senate — $100 million for Agriculture and Food Research Institute.
• National Institute of Standards and Technology: House — $300 million to construct research buildings at colleges; Senate — no funding.
• Agricultural Research Service: House — $209 million for facilities; Senate — no funds.

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carminic acid

This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives.  This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).

To read the Federal Register notice, click here.

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Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the labeling requirements of section 403(y) ofthe FFD&C Act apply to all dietary supplements labeled on or after December 22, 2007. Therefore, these labeling requirements are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until January 1, 2010.

FDA would have no objection to a firm’s combining the recommended statement with language informing consumers that the domestic address or phone number on the label may also be used for other purposes, as long as the information provided is not false or misleading. For example, a dual-purpose label statement might be “To report a serious adverse event or obtain product information, contact. .. ” or other similar language.

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In a Federal Register notice published in January 2007, the FTC sought public comment on the overall costs, benefits, and regulatory and economic impact of the Guides, which were last updated in 1980. In the newly approved Federal Register notice, the FTC’s proposed revisions to the Guides address consumer endorsements, expert endorsements, endorsement by organizations, and disclosure of material connections between advertisers and endorsers. On the issue of consumer endorsements, the proposed revisions state that testimonials that do not describe typical consumer experiences should be accompanied by clear and conspicuous disclosure of the results consumers can generally expect to achieve from the advertised product or program.

To read the press release, click here

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There is plenty on the web about this. To keep track of the bill status, click here. Stay tuned for an analysis of the acts requirements after passage.

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