The American Herbal Products Association (AHPA) filed comments with the U.S. Food and Drug Administration (FDA) last week to comment on an interim final rule that implements one section of the Food Safety Modernization Act (FSMA) of 2011.
Section 207 of FSMA amended the Federal Food, Drug and Cosmetic Act by changing the criteria under which FDA is authorized to order administrative detention of a food—including a dietary supplement—from 20 to 30 days. FSMA amended this authority so that FDA is now allowed to order such detention of a food if it has "reason to believe" that the food is "adulterated or misbranded." The authority was previously limited to instances in which the agency had "credible evidence or information" indicating that a food "presents a threat of serious adverse health consequences or death."
FDA's interim rule modifies two section of Title 21 of the Code of Federal Regulations, and specifically § 1.378 ("What criteria does FDA use to order a detention?") and § 1.393 ("What information must FDA include in the detention order?"), in language that exactly mirrors the language in FSMA.
AHPA's comments suggest that FDA continue to use its administrative detention authority sparingly (the agency has never used it since it was granted in 2004). AHPA also notes, however, that Congress did not limit administrative detention to food that is in domestic commerce, such that "any detention of food that is made due to FDA's determination that is has a reason to believe that the food is adulterated or misbranded, including detentions at a point of importation or of domestic possession, should be considered to be an administrative detention."
If FDA agrees with this analysis, any adulteration—or misbranding-based adulteration—would be subject to certain rules, including that such detention could not exceed 30 days.
AHPA also commented that the agency should be required to provide specific, rather than only general information, on the reasons for any administrative detention, and that better training of FDA field office personnel may reduce incidents of detentions that are later found not to violate any federal provisions.
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. www.ahpa.org.