By Heather Van Blarcom
General Counsel & Senior Regulatory Specialist for Dietary Supplements
For the moment, the Dietary Supplement Health and Education Act of 1994 (DSHEA) remains intact. In his relentless pursuant to stymie the dietary supplement industry, Senator Richard Durbin (D-Illinois), unexpectedly sought to attach a last minute amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, a pending act which many consider to be a “must pass” piece of legislation. Senator Durbin’s proposed amendment would, among other things, have required supplement manufacturers to register all products and their ingredients with the FDA within 30 days of introduction, reformulation or discontinuation. Thanks to Senators Orrin Hatch (R-UT), Tom Harkin (D-IA) and Mike Enzi (R-WY), who believe that people and not government should be in charge of their nutritional choices, and the coordination of all five trade associations (the American Herbal Products Association, the Natural Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance), the U.S. Senate voted 77 to 20 to table the amendment.
Essentially, Sen. Durbin was seeking to require manufacturing facilities to submit to the FDA a description of each product manufactured, a list of ingredients in each product, and a copy of the label and labeling every two years. Further, this same information would have to be provided to the FDA for every new and discontinued product within 30 days of either the marketing of the product or its removal from the market. Any product made in a facility found not in compliance with this proposed requirement would have been deemed adulterated. Sen. Harkin pointed out that the proposed amendment was unnecessary as manufacturers are already required to list all ingredients on product labels and that product labels are already required to be changed when a product’s formulation changes. The American Herbal Products Association (AHPA) rightly stated that the proposed amendment would have placed an “unnecessary product registration burden on supplement companies, including small businesses.”
Sen. Hatch said it best in speaking to Congress prior to the vote when he stated that the proposed amendment “is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks the authority to regulate these products.” The speed at which this proposal almost became law underlines the moral of this story which is that the industry must never become complacent in its efforts to ensure that DSHEA remains intact.
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