As anticipated, Senator Richard Durbin, D-IL., has reintroduced the Dietary Supplement Labeling Act. The bill, co-sponsored by Sen. Richard Blumenthal, D-CT, would require dietary supplement companies to register all supplements with the Food and Drug Administration (FDA) and would amend certain supplement labeling requirements.
Commenting on the reintroduced legislation, Silver Spring, MD’s American Herbal Products Association (AHPA) president Michael McGuffin said, “Like the previous version of this bill, the legislation would impose a product registration requirement for dietary supplements even though conventional foods bear no such burden. There is no reason that product registration is needed specifically for dietary supplements and AHPA opposes this provision.”
The bill also directs the Department of Health and Human Services to coordinate with the Institute of Medicine 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.
“There are numerous authoritative references already available to provide safety information on dietary ingredients, including AHPA's Botanical Safety Handbook for herbal ingredients,” said Mr. McGuffin. “Instead of using taxpayer funds to reinvent the wheel, the existing resources should be recognized.”
The bill would also require the Secretary of Health and Human Services to establish a definition for the term “conventional food” for purposes of the Federal Food, Drug, and Cosmetic Act; require FDA to establish mandatory warning label requirements for some dietary supplements; and mandate inclusion of a batch number on each supplement product label.
“The issues addressed in Senator Durbin's bill appear to propose legislative solutions where regulatory standards would suffice,” Mr. McGuffin said. "Under current law, supplements are not allowed to 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 batch numbers, it is already the standard industry practice.”
The Council for Responsible Nutrition (CRN), Washington, D.C, voiced similar concern to AHPA. According to Steve Mister, president & CEO of CRN, the organization “appreciates Sen. Durbin’s continued interest in providing consumers with additional assurance of the safety and benefits of their dietary supplements. However, we oppose the Dietary Supplement Labeling Act of 2013 because it creates added burdens for both FDA and companies already following the law, but does not address the problem of those companies that are disregarding the law.” He added, “Without robust enforcement, companies who look for loopholes and disregard their legal obligations will continue to ignore new requirements. 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.”
Mr. Mister also expressed that CRN does not support legislation “that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or miniscule risks. Further, a new law is unnecessary because the Dietary Supplement Health & Education Act (DSHEA) already provides FDA with the authority to mandate warning labels if the agency determines there is an unreasonable risk of injury or illness under the conditions of use provided in the labeling. Other provisions of the legislation likewise create burdensome new mandates for manufacturers who are already complying with DSHEA without addressing the industry’s outliers.”
Further, Mr. Mister added, “We share Sen. Durbin’s concern that consumers should be able to expect dietary supplements are safe and beneficial, but adding new layers of bureaucratic mandates is a shotgun approach when we need FDA to take a rifle-like aim at companies that are putting consumers at risk.”