This article is written by contributing writer Shafiel A. Karim
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.
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.