When the Final Rule on good manufacturing practices (GMPs) for dietary supplements was issued by the U.S. Food and Drug Administration (FDA) in 2007, the document (including its preamble) was more than3 inches thick. Yet, despite all of the detailed FDA commentary in the document and despite—or because of—the specific new rules laid out therein, many in the supplement industry have argued that the GMP standards created by the agency are vague and arbitrary.
Three groups even went so far as to sue the FDA on the basis that the GMP Final Rule exceeded the agency's statutory authority, was impermissibly vague and arbitrary and capricious. However, a federal court recently upheld FDA's regulations for GMPs, thus dismissing all of the challengers' complaints.
Although this court decision is likely being celebrated by GMP supporters, it does mean that supplement manufacturers must continue operating in a rather murky regulatory environment.
The litigator in this case was none other than the famous and well-respected Jonathan Emord, who has prevailed in many challenges against the FDA. He is perhaps best known for the qualified health claim victory. The challengers, or plaintiffs, were:
- The Alliance of Natural Health—which represents practitioners, MDs, scientists, consumers and patients, affecting all facets of the dietary supplement industry;
- Pearson and Shaw—supplement formulators and self-described best-selling authors; and
- The Coalition to End FDA and FTC Censorship—whose mission and purpose is “advocating that federal government agencies not block consumer access to accurate representations concerning the existing science on the role of nutrients in treating and preventing disease.”
Most people in the dietary supplement industry were in favor of strong standards for supplement GMPs. Supporters of the rules include the industry's trade associations and consumer groups, such as the American Herbal Products Association (AHPA), the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN). Many manufacturers believe that having GMP requirements will boost consumer confidence in the safety of supplements.
What constitutes ‘appropriate'?
Still, it can be argued that the wording of the regulations is indeed vague and general in many sections. For example, one section of the rules states the requirement to maintain “adequate” and “readily accessible” bathrooms.
This vagueness could be considered an issue because, once the FDA began sending warning letters to supplement manufacturers regarding their failures to adhere to the new rules, it became apparent how broadly the agency was enforcing GMPs during inspections.
This broad approach to enforcement can be seen in the following examples of the FDA's citations and objections as published in GMP-related warning letters:
- “. . . additionally, you did not make and keep documentation demonstrating why the results of appropriate tests or examinations for the product specifications selected under 111.75(c)(1) ensure that your dietary supplements meet all products specifications in accordance with 21 CFR 111.95(b)(4).” [Coats Holding Co.; emphasis added.]
- “Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i).” [Emphasis added.]
- In a letter sent to The Hain Celestial Group, one of the citations was failure to include “astatement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].” [Emphasis added.]
- In various letters: “You failed to verify that your laboratory examination and testing methodologies are appropriate for their intended use [21 CFR 111.320(a)].” [Emphasis added.]
- The FDA also can cite and has objected to “inadequate” responses to a Form 483 following an inspection: “We reviewed your response dated September 2, 2010 and concluded that it is not adequate because you did not provide supporting documentation.” [Emphasis added.]
You get the idea. It must be conceded that some of the manufacturers that have received GMP-related warning letters from the FDA had an absolute absence of any documentation or record-keeping in certain required areas. However, in general, both the GMP regulations and the inspection warning letters can leave manufacturers wondering: What level of documentation is considered to be “sufficient,” and what sort of rationale for an SOP is considered to be “reasonable”? In addition, the FDA has requested documentation to explain the rationale behind the specifications that the company has (for example, for testing raw materials). This demonstrates that the FDA is not only looking for specific, written documentation and SOPs, but that the agency also requires a well-reasoned rationale behind those SOPs. Who decides what is “reasonable”? Clearly, this requirement is subjective and circular, but it is something that should be expected during an FDA inspection.
The overall significance of the GMP regulations being upheld in this most recent court case is that the costs of supplement manufacturing will continue to increase, with those higher costs being passed along to the retailer and ultimately to the consumer. The rigor and specificity of the GMPs has already caused some small manufacturers to go out of business. But we should keep in mind that the plaintiffs in this case were not challenging the rigor, but rather the vagueness of some GMP rules. As Jonathan Emord explained, under both the Fifth Amendment and Congressional expectations for these FDA regulations, there is a requirement for “sufficient clarity of regulation so that the regulated class [manufacturers] can discern what is expected of it [in order to follow the law]. The GMPs lack that requisite clarity.”
It is important to observe that during most FDA manufacturing inspections there was no actual contamination of contents found; yet the products at issue were still determined to be "adulterated" based on the technical GMP violations alone. For example, in some letters, the FDA objected that the documentation was not sufficient to ensure and maintain “. . . limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, to comply with 21 CFR 111.95(b)(3). [My emphasis.]
This is significant because a finding of adulteration allows criminal prosecution and enforcement under the Federal Food, Drug, and Cosmetic Act. Jonathan Emord's logic presents a worse case scenario for an unlucky manufacturer: “In such a circumstance [a criminal charge,] greater precision is required than in the ordinary civil context. In short, the GMPs are so vague as to permit criminal prosecution without the regulated class knowing that its action gives rise to a claim.”
Although the Plaintiffs may decide to appeal this case, Alliance for Natural Health US et al v. Sebelius et al., my view is that chances for reversal are as great as the odds for snow in the desert in June.
*This blog is not meant, and should not be construed, as a legal opinion or legal advice; nor does it necessarily reflect the views of the author's law firm.