WASHINGTONA bill that has been reintroduced by Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT) would require manufacturers of dietary supplements to register their products with FDA and furnish a description of each product, its ingredients and a copy of the label. Manufacturers also would be required to notify FDA if they removed a product from the market.
First introduced in June 2011, the Dietary Supplement Labeling Act is designed, in part, to provide consumers with more information about the potential risks of dietary supplements and empower FDA with the authority to demand documentation verifying claims on labels are backed by competent and reliable scientific evidence.
"The bill I am introducing today with Sen. Blumenthal builds on the work we have done in the past with common-sense steps to make sure supplement risks are printed on the label, products are registered with FDA, and manufacturers can back up their big claims," Durbin said Thursday in a statement.
Durbin and Blumenthal contend recent reports by USA TODAY and "Rock Center with Brian Williams" have shown a dearth of information on dietary supplements that are on store shelves. Some lawmakers and other critics argue supplements are under regulated because the products do not require pre-approval from FDA before they land on store shelves and the Internet, with labels touting myriad health benefits that may conceal dangerous side effects.
The Dietary Supplement Labeling Act would give FDA the authority to require manufacturers, upon request, to submit documentation to support structure and function claims on their labels. FDA explains that such claims "describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, 'calcium builds strong bones.'" Supplement firms are prohibited from making claims that they can treat diseases such as osteoporosis.
Under current federal law, manufacturers must notify FDA about their structure/function claims within 30 days after introducing a supplement into the market, and certify that such claims are substantiated with competent and reliable scientific evidence. But the agency doesn't have the authority to compel a manufacturer to submit substantiation documents upon request, according to a government report published in October 2012. In the report, the Office of Inspector General within the Department of Health and Human Services (HHS) recommended that FDA seek explicit statutory authority to review substantiation to determine whether structure/function claims are truthful and not misleading.
Marc Ullman, a New York-based dietary supplement lawyer, said FTC already has the authority to require firms to submit substantiation documents in support of their structure/function claims, but he acknowledged it is "less clear how FDA would get at it."
Warnings on Labels
The American Herbal Products Association (APHA) explained the legislation further directs HHS "to coordinate with the Institute of Medicine [IOM] to compile a list of dietary supplement ingredients that could cause potentially serious adverse events, drug interactions, contraindications or potential risks to subgroups such as children and pregnant or breastfeeding women." (FDA is a part of HHS). If a proprietary blend contains such an ingredient, supplement firms would be required to disclose the weight per serving of that ingredient on the label.
Warnings on labels would be required if ingredients posed the risks noted by AHPA. The legislation also would require that batch numbers are included on each supplement label in a move designed to help FDA identify and recall dangerous products.
The proposed warnings are unnecessary, Ullman declared, because supplement companies already must include directions for use to ensure that a product is safe.
"So, if there is a population that shouldn't be using it like pregnant or nursing women, you are supposed to put that information on your product label," he said.
Food v. Supplement
AHPA noted the legislation also would require the HHS to define the term "conventional food." Durbin and Blumenthal want to more clearly distinguish conventional foods from dietary supplements since the two categories are subject to different federal regulations.
The senators maintain some energy drink companies have subjected themselves to dietary supplement regulations in order to skirt more onerous food regulations. But attorneys who practice dietary supplement law point out some meaningful regulationsincluding a 2006 law (Dietary Supplement and Nonprescription Drug Consumer Protection Act) requiring that dietary supplement firms submit such "serious adverse events" as death and hospitalization in connection with their productsdon't apply to conventional foods.
Justin Prochnow, a Colorado-based dietary supplement lawyer, said the legislation is basically asking for "FDA to apply tougher enforcement and declare some products that are labeled as supplements to really be food or beverage."
Merits of Legislation Debated
Amy Gadhia, senior policy counsel for , indicated the legislation could result in safer supplements.
"Many supplements may be safe and healthful, but there are numerous ingredients found in a variety of supplements that pose significant dangers to consumers. This bill would mean stronger requirements for manufacturers to deliver safe products and better labels with more information for consumers," she said in a statement.
Others representing supplement companies argue the bill will impose additional burdens on legitimate, law-abiding companies without restraining firms that are violating current regulations.
"Without robust enforcement, companies who look for loopholes and disregard their legal obligations will continue to ignore new requirements," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement. "Rather than creating new laws, our industry needs a renewed commitment from Congress to provide FDA with additional funding and resources so the agency can use the ample enforcement tools already at its disposal to take aim at companies that do not comply with the regulations currently in place to protect consumers."
The United Natural Products Alliance (UNPA) also is opposed to the legislation. UNPA President Loren Israelsen argues the bill "would likely impede progress towards cracking down on unlawful actors by adding an unfunded set of mandates to an already underfunded FDA dietary supplement enforcement effort."
Tamara Ward, a spokesperson for FDA, did not respond to a request for comment on the legislation.