Last week, 14 state attorneys general sent a letter to Congress requesting that it investigate the herbal supplements industry, as well as consider giving the US Food and Drug Administration (FDA) stronger oversight authority over the marketing of such products in the US. (A link to the state AG letter follows here.) This letter is consistent with mounting efforts by states to take enforcement action against a class of products regulated nationally by the FDA.
The letter, which was sent to the Chairman and Ranking Member of both the Senate Subcommittee on Consumer Protection and the House Subcommittee on Health, was co-signed by the attorneys general of Connecticut, the District of Columbia, Hawaii, Idaho, Indiana, Iowa, Kentucky, Massachusetts, Mississippi, New Hampshire, New York, the Northern Mariana Islands, Pennsylvania, and Rhode Island.
The letter notes that recent state investigations have raised questions about the marketing and safety of herbal supplements — and references recent product testing that 1) identified a variety of contaminants included in finished supplements; and 2) raised questions about whether certain herbal ingredients reportedly included in some products were present at all. These findings were, in part, based on DNA testing, which some members of industry have stated is an inappropriate testing methodology for identifying processed plant material.
The letter states that the FDA has long been aware of compliance problems related to the dietary supplement supply chain — noting that in FY 2013, the FDA cited two out of every three supplement manufacturing facilities inspected with good manufacturing practice (GMP) violations. The state AG letter expresses even greater concern over dietary supplements/dietary ingredients of foreign origin.
The letter further notes that “states will continue to vigorously pursue supplement manufacturers and retailers who break public health and consumer protection laws…” The letter concludes by requesting that Congress and the FDA determine whether current quality assurance measures for supplements/supplement ingredients are adequate and effective; and whether terms associated with the marketing and labeling of dietary supplements (e.g., “natural”; “herbal”, “extract”) are misleading to consumers.
We expect these and other state attorneys general to remain active in investigating and possibly taking enforcement action against both manufacturers and marketers of dietary supplements. We will continue to follow these state AG developments and will provide additional updates when new information becomes available.