Breaking News: Senator Durbin to Introduce New Dietary Supplement Legislation

June 29, 2011

The bill’s announcement comes on the heels of a letter Durbin sent to FDA recently, questioning the agency’s policy on foods containing ingredients such as melatonin.

Sen. Richard Durbin (D-IL) will introduce a new dietary supplement bill in the next week that asks FDA to establish a definition for “conventional foods,” while also requesting enhanced labeling and registration requirements.

In a press release posted to his website, Durbin states that his Dietary Supplement Labeling Act will “curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA.”

The bill’s announcement comes on the heels of a letter Durbin sent to FDA recently, questioning the agency’s policy on foods containing ingredients such as melatonin. (Melatonin is not an approved food additive, and FDA has already issued warning letters to companies marketing foods with melatonin, such as the beverage Drank, which rebranded itself as a dietary supplement after receiving FDA’s warning letter.)

“At most convenience stores, you can’t make it to the cash register without encountering flashy advertising displays for energy supplements like Rockstar Energy Drink and 5-Hour Energy,” Durbin’s press release states. “These products, which market themselves as dietary supplements that offer a boost of energy, are foods and beverages taking advantage of the less-stringent safety standards for dietary supplements under current law.”

Durbin’s bill asks FDA to define “conventional foods, which would clarify which products are foods and should be regulated as such and which products are meant to be health aids and should be regulated as dietary supplements…My gripe is not with the array of vitamins available at health stores across the nation; my gripe is with the products containing potentially dangerous additives, labeled as ‘dietary supplements’ and marketed to young adults who find them on store shelves right next to conventional food and beverages whose ingredients have been deemed safe by the FDA.”

The bill would also require manufacturers to:

  • On product labels, disclose “known” risks of ingredients and display a mandatory warning if a product contains an ingredient that may cause potentially serious adverse events.

  • Include batch numbers on product labels to help FDA identify and recall products.

  • Register dietary supplement products with FDA, including a description of each supplement, a list of ingredients, and a copy of the label.

Industry associations are keeping a close eye on the bill’s developments. Their concerns will likely stem over whether Durbin’s bill covers regulations already in place.

“In reviewing this press release, it appears that this bill would largely propose legislative solutions where what is needed is regulatory enforcement,” stated Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). “Supplements may not be represented as conventional foods and must be labeled to include all information-including safety information-that is material in light of the consequences that may result from their use. And while no one will argue with the wisdom of using product lot numbers, it is already the standard industry practice to do so.”

AHPA notes that the requirement for product registration may be the most controversial part of the bill and notes that Durbin has sought similar changes in the past.

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