On Friday, July 1, when most were focusing on a congressional break and a holiday celebration, Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) officially introduced a bill that would have an impact on dietary supplements for both manufacturers and users. The Dietary Supplement Labeling Act of 2011, S. 1310, would clarify “conventional foods” and place the FDA in the role of defining which products are foods, and which are health aids and therefore subject to regulation as dietary supplements for FDA policing.
According to Drug Store News the legislation would require supplement manufacturers to register dietary supplement products with the FDA and “provide a description of each dietary supplement, a list of ingredients and a copy of the label. Additionally, the new law would require product labels to include warnings associated with adverse events of specific ingredients, weight of those ingredients per serving and a batch number for easier recall.” The bill goes further, requiring updated registration when making a new product not registered previously, when a registered product is reformulated, or when it discontinues making a registered product. These bureaucratic regulations will greatly increase the cost of bringing supplements to market, and easily chase many small manufacturers out of business.
Durbin says he’s only concerned that some products contain “potentially dangerous ingredients” which haven’t been FDA approved. “My gripe is with products labeled as ‘dietary supplements’ whose ingredients have not been deemed safe by the FDA but are found on store shelves right next to conventional food and beverages. The current system favors the manufacturers of these products to the detriment of consumers – and that needs to change,” related Durbin on his webpage. “Detriment” wasn’t documented or defined, though. He added, “These products market themselves as dietary supplements that are safe ways to relax or get a boost of energy, when in reality they are foods and beverages taking advantage of the more relaxed safety standards for dietary supplements. My bill would help curb this unsafe practice.”
The net that Durbin casts with S. 1310 is very large and would indeed snare not only energy drinks, but dietary supplements be they in the form of vitamins, herbs, minerals, extracts, formula blends, etc, and used alone or added to food products. In May Durbin objected to, and alerted the FDA to, baked goods that contained melatonin, a naturally occurring compound that synchronizes the circadian rhythms of certain biological functions. (Many folks take melatonin supplements to counter sleeplessness at night thereby avoiding FDA-approved habit-forming narcotics.)
Durbin incorrectly presupposes that nothing is safe unless government approves it. He conveniently ignores the fact that consumers are not forced to purchase or ingest these products; it is their choice to do so. Therefore it is the consumer who must regulate personal purchases and uses, not big government, the legislative branch, or some bureaucratic agency. Durbin’s big brother interference in the supplement market is another example of overregulation and destruction of individual choice whether it be for baked goods, or for supplements that treat the common cold. It’s quite hypocritical of Durbin to continue overlooking all the hundreds of unsafe and damaging drugs that have had devastating consequences and even caused death that the FDA has approved.
Contact your Representative and Senators urging them not to cosponsor, support, or vote for such a power-grabbing bill. Let them know Americans want unrestricted access to nutritional supplements produced by manufacturers whose focus is their product -- not multiple government registration and labeling forms. Help keep the government out of our health aid and food choices.