Sen. Richard Durbin (D-IL) is calling for more regulation of dietary supplement products to ensure consumers have information they need to distinguish between safe products and others that contain potentially dangerous ingredients that haven’t been approved by FDA.

He announced intentions to introduce the Dietary Supplement Labeling Act, as early as this week. According to Sen. Durbin’s press release, the bill would:

• Direct FDA to establish a definition for “conventional foods”;
• Require supplement labels to disclose known risks of ingredients and to display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events;
• Require manufacturers to register dietary supplement products with FDA, and provide a description of each dietary supplement, a list of ingredients and a copy of the label; and
• Require supplement labels to include a batch number.

The press release makes it clear he is most focused on products in food or beverage forms and specifically mentions several liquid brands, including Rockstar Energy Drink, 5-Hour Energy and Drank. The latter contains melatonin and, according to the press release, the company rebranded the product as a dietary supplement when FDA issued a warning letter last year, which identified melatonin as an unapproved food additive. According to Sen. Durbin, “FDA has not yet taken action, because without a clear definition for ‘conventional food and beverage’ it is difficult to address this kind of conflict.”

“In reviewing this press release, it appears that this bill would largely propose legislative solutions where what is needed is regulatory enforcement,” said 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.”

The most controversial part of the Dietary Supplement Labeling Act may well be its requirement for product registration, a change that Sen. Durbin has sought in the past.

“AHPA is in communication with Sen. Durbin’s office, and I will be reviewing the actual legislation as soon as it is available,” added Mr. McGuffin. “As always, AHPA’s primary focus will be on identifying and opposing any legislation that in any way reduces consumer access to safe dietary supplements.”