by Nadia A. Karim
The Park Doctrine, as decided by the U.S. Supreme Court in United States v. Park, could be a potential threat to the dietary supplement industry. Under Park, companies can be criminally sanctioned for non-compliance with cGMPs (current good manufacturing practices). Firms already struggling with qualitative and quantitative testing (e.g., pre- and post- production), quality control (QC), validation and documentation stand to face potential criminal consequences irrespective of whether there was intent to disregard cGMP. If a dietary supplement firm is struggling with compliance related to the necessary testing requirements, it naturally follows that the firm likely will not be able to provide proof that a product is safe for human consumption as required by the new rules.
It helps to understand the background of the Park Doctrine. In 1975, John Park, president of Acme Markets Inc., a national food retailer based out of Maryland, was charged and convicted for violating elements of the Federal Food, Drug and Cosmetic Act (FDCA). Acme’s warehouses were found to be insalubrious due to rodent infestations, and adulterated food was distributed in interstate commerce. The investigators cited multiple violations of prohibited acts that were subject to prosecution for a criminal misdemeanor. The court stipulated that rigorous criminal liability would be placed on senior officers of a company if the company engages in infractions. Even if a senior officer did not personally take part in, commit or know about an occurring violation, the officer will still be held liable.
The court argued “[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.” [Park, 421 U.S. 672] FDA will criminally persecute those firms that grossly violate—or have numerous violations without taking corrective actions—FDCA and cGMP parameters or end consumer products that pose a serious risk to the general public.
Park affects the dietary supplement industry because a dietary supplement is considered “adulterated” if it is prepared, packed and/or held in conditions that are not in accordance with cGMP, or if it is comprised of poisonous or hazardous ingredients. This means manufacturers in the dietary supplement industry need to uphold strict cGMP guidelines in order to ensure end consumer products are not adulterated. Certainly, rodent infestations cause apparent deleterious effects; but, even raw materials that fail microbial analysis would likely be grounds for potential Park sanctions because they could pose a substantial public health risk. Other sources of adulteration such as air handling, water purification systems and validated cleaning procedures need to be carefully attended to so as to avoid contamination and cross-contamination. Additionally, raw materials and dietary supplements that violate maximum permissible heavy metal statutes may also be potential violations subject to criminal sanctions. Therefore, companies should take the necessary precautions to ensure cGMP compliance by investing in QC systems and procedures.
Nadia Karim is a graduate of the University of California, Los Angeles (UCLA), and is the project manager for NHK Laboratories Inc ., a GMP, ISO 9001:2008, organic- and halal-certified custom formulator, contract manufacturer and contract packager of private label dietary supplements.