WASHINGTON — U.S. Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., on Thursday introduced legislation that would retool the labeling requirements for dietary supplement manufacturers, require pre-market certification on new products and require successful efficacy trials. The legislation also was written to better deliniate regulatory requirements for dietary supplements vs. food.
The bill is not supported by industry.
“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," noted Steve Mister, president and CEO for the Council for Responsible Nutrition. "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."
The additional legislation would prove superfluous, Mister argued. "A new law is unnecessary because the Dietary Supplement Health & Education Act 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," Mister said. "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 the FDA to take a rifle-like aim at companies that are putting consumers at risk."
Following recent investigative reports by “USA Today” and “Rock Center,” the senators identified what they perceive as a lack of information about dietary supplement products that on store shelves. “Though many dietary supplements available today are safe, we can’t ignore the growing evidence that there are some in the industry who are taking advantage of the system we have in place to make money selling products they know are harmful,” Durbin said. “Regulation of supplements can be improved to protect public health, and it starts with making more information available to consumers and the FDA," he added. "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 the FDA and manufacturers can back up their big claims.”
The senators cited a March 2013 Government Accountability Office report found that between 2008 & 2011, the FDA received an average of 2,100 dietary supplement adverse event reports a year compared to less than 400 in 2007, when there was no mandatory reporting of serious adverse events. The report also suggested that there is underreporting of adverse events to the FDA because consumers and healthcare practitioners are more likely to call poison control centers than they are to report a problem to the FDA or manufacturer.
The Durbin-Blumenthal would give consumers of dietary supplements a clearer understanding of what they are taking by:
- Allowing the FDA to track how many dietary supplements are on the market and what ingredients they contain. Under The Dietary Supplement Labeling Act, manufacturers would be required to provide registration information for new products within 30 days after being marketed. They also would be required to provide a description of each product, its ingredients and a copy of the label. If a product is removed from the market, they would be required to inform the FDA;
- Requiring more information on product labels, including warnings associated with specific ingredients, such as a warning if the product contains an ingredient that may cause serious adverse events, drug interactions, contraindications or risk for such subpopulations as children and pregnant women. If a proprietary blend contains such a dietary ingredient, the weight per serving of that ingredient must be disclosed on the label. Labels also would have to include the batch number, which would help the FDA identify and recall contaminated product;
- Giving FDA the authority to require manufacturers to provide proof for any potential health benefit claims. Manufacturers would be required to have substantiation supporting claims on product labels to ensure they are truthful and not misleading; and
- Directing the FDA to clarify the distinction between dietary supplements and food and beverage products with additives. "The vague distinction between a dietary supplement and a conventional food has created a murky and growing market space where industry is selling products like beverages with high levels of additives that act as stimulants and brownies with high levels of ingredients that lull the body into relaxation," the senators noted. "The bill would direct the FDA to establish a definition for “conventional foods” in order to clarify for industry, for consumers and even for the agency itself what products are foods and should be regulated as foods and what products are meant to be health aids and should be regulated as dietary supplements."