Advertising Law Blog

Manufacturers, distributors and retailers of dietary supplements have become the target of new legislation proposed by Senator McCain and co-sponsored by Senator Dorgan. S.3002, The Dietary Supplement Safety Act of 2010, is currently pending before the United States Senate. The proposed legislation seeks to modify the Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 ("DSHEA") on matters relating to safety.

Under the proposed amendments, all dietary supplement facilities, (referred to in the legislation as "registrant") including manufacturers and distributors, would be required to update their registration annually with the Secretary of Health and Human Services. To be included in that registration application are, the name and address of each facility, all trade names under which the registrant does business, all the names of supplements manufactured, packaged, held, distributed, labeled, or licensed by facility; a list of ingredients in each supplement, new formulations of existing supplements, and formulations of new products, and a copy of each label used on each product.

The proposed Dietary Supplement Safety Act would apply to ingredients not included on a list called the "accepted dietary ingredients." This list is to be prepared, published, and maintained by the FDA using all of the information provided by registrants. Importantly, all new ingredients will be considered adulterated by the Secretary unless the manufacturer can a history of prior use establishing safety or other evidence, including citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing the dietary ingredient will be reasonably expected to be safe This information is to be provided to the FDA no later than 75 days before the interstate distribution date. Retailers would be required to obtain written evidence from the responsible entity that the product is registered as required, and make such evidence available for review upon FDA inspection.

Additionally, the FDCA required that a report be submitted containing any "serious adverse events" arising out of the use of a supplement. The proposed amendments will require facilities to include non-serious events arising out of the consumption of a product consumed in the United States. These reports are to be maintained for a period of three years.

The FDA would have absolute enforcement discretion. If FDA deems an ingredient or product adulterated, or dangerous to the health of consumers, it can issue a cease distribution order. The party named in the order will be required to stop the manufacture, and distribution of the product, and must notify all other entities in the chain of distribution and manufacture of the cease distribution order. The party named in the order is entitled to a hearing within 10 days of receiving the cease distribution order, and must provide notice of its intent to challenge the order within 5 days of receiving the order. Subsequent to the hearing, FDA will decide either to rescind the order, or to amend the order and recall the product entirely. If a recall is required, FDA will issue a timetable for the recall's implementation and retailers, at their own expense, must notify consumers, including those that have already bought the product, of the recall. If identification is unknown, the FDA will assist in the notification

While this legislation clearly sets out to keep a closer eye on new dietary supplement ingredients, and is well intentioned in protecting the consumer, it will place a heavy burden on the manufacturers and distributors of dietary supplements and restrict consumers access to dietary supplement products. Moreover, there would be significant penalties for non-compliance. Proposed penalties are two times gross revenue derived from the sale of a violative product. While the Senate reviews the legislation, the lobbying war is on and it will remain to be seen if Congress grants FDA these new rules of enforcement.