The US Food and Drug Administration (FDA) is out with a new final guidance and compliance guide for small businesses regarding how it treats the administrative detention of foods, including supplement products.
The guide references regulations released in 2004 per the Bioterrorism Act of 2002, which authorized FDA to detain or otherwise deny entry to any article of food if it had credible evidence that the food could cause serious injury, harm or death to humans if consumed. The 2004 regulation established administrative detention procedures, which were then updated in 2011 under the Food Safety Modernization Act (FSMA).
Under FSMA, FDA was allowed to detain food products based on a lower standard of evidence: if a product was adulterated or misbranded-even if it wouldn't be harmful or cause injury-it would be administratively detained. Regulations codifying this authority were adopted on 5 February 2013.
New Authority Raises Questions
That increased authority raised a number of difficult and frequently asked questions for small business entities, many of which distribute their products within the US to reach a broader market.
For some, the most basic question was simply, "What food is subject to administrative detention?" While most consumers think of food in the now-outdated food pyramid-grains, meats, dairy, vegetables, fruits, fats, oils and sweets-US law actually classifies dietary supplements and nutritional supplements as food products as well.
"The term food also refers to dietary supplements, which are to be treated as food under the Federal Food, Drug and Cosmetic Act," FDA wrote. "A dietary ingredient in these products may include: vitamins, minerals, herbs, or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates and may come in many forms as long as they are labeled as a dietary supplement and not represented as a conventional food or sole item of a meal or diet."
That means dietary supplements are subject to the new administrative detention procedures as well.
Under the regulation, FDA's district office directors can approve administrative detention orders based "factual information that a food is adulterated or misbranded," which will be considered on a case-by-case basis.
"The administratively detained article of food must be held in the specified location and under the conditions specified by FDA in the detention order," FDA explained, but these orders can be modified to allow for the product to be destroyed or moved to a facility for re-processing or proper storage conditions.
The orders themselves will be issued to the owner, operator or "agent in charge" of the location where the food product is currently located, and to the owner if the article is detained by someone other than the owner.
FDA also noted that administrative detention is different than import detention, both in the regulatory authority they use to detain products and the process of detention. Import detentions are more like holds, as neither FDA nor Customs and Border Protection officials ever have legal possession or control of the food articles. In an administrative detention, however, FDA will physically detain the food articles.
FDA noted that the company whose products have been detained, and not the agency, are responsible for the costs associated with the detention, including storage, moving, disposal and reconditioning.