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.