Durbin, D-IL and Blumenthal, D-CT issued their statement in connection with the announcement that the Food and Drug Administration had elevated the Division of Dietary Supplement Programs to an ‘Office,’ a development widely applauded in the industry.
“Just as dietary supplements have outgrown their current spot in FDA’s organizational chart, dietary supplements have also outgrown the two-decades old law that was supposed to oversee this industry and protect consumers. Comprehensive new legislation is needed to provide the necessary oversight of this $35 billion industry, and we intend to introduce legislation in the new year. As the FDA seeks to establish permanent leadership for this new office, we urge the agency to identify a strong leader that will aggressively pursue wrongdoing, vigorously enforce the law, and use all the tools at its disposal to protect consumers and push for increased transparency by the industry on the purity, quality, and identity of the products they manufacture,” the Senators wrote.
Representatives of the Natural Products Association and the Council for Responsible Nutrition said that specific comments on what Durbin and Blumenthal are proposing would have to wait until a draft of the bill was on the table. But the fact that the Senators intended to do something along these lines was expected, though that does not mean they were taking the matter lightly.
“We got a hold of it right after they issued it late last year,” Dan Fabricant, PhD, executive director and CEO of NPA told NutraIngredients-USA. “We’re not surprised. It’s really a matter of what they are asking for and what they are looking at.”
Mike Greene, vice president of governmental affairs for CRN, said this development in fact comes a little later than expected.
“Senators Durbin and Blumenthal have been threatening to reintroduce the Dietary Supplement Labeling Act. We expected it last year but it never came. When the statement came out it was a little bit alarming but at the same time we understood where they were coming from and to some degree we expected it,” he said.
Durbin first introduced the bill in 2011 and had another go in 2013. The bill in its most recent guise requires regulators to compile a list of dietary supplement ingredients and proprietary blends of ingredients that are judged to be capable of causing potentially serious adverse events, drug interactions or risks to subgroups such as child or pregnant or breastfeeding women. In addition, the bill would expand registration requirements by mandating manufacturers to submit a list of all the products and their ingredients they make at a given facility. New products or reformulations would require new registrations.
Michael McGuffin, president of the American Herbal Products Association, had this to say: “AHPA agrees with the urging of Senators Blumenthal and Durbin for FDA to ‘vigorously enforce’ the current law and to ‘aggressively pursue wrongdoing.’ AHPA and the responsible supplement industry have consistently supported full enforcement of supplement laws and regulations for the past 20 years. Under current law, all supplement companies must comply with comprehensive manufacturing regulations, strict controls on marketing claims and labeling, facility registration, and reporting requirements on rare serious adverse events.
“The senators' call for new legislation, however, ignores the existing extensive laws. Instead of starting from scratch, the government could more effectively protect consumers by fully enforcing current requirements.”
Blumenthal in the lead?
Durbin and Blumenthal have cooperated in the past on issues surrounding the formulation and marketing of caffeinated energy drinks, but it has been Durbin who was in the forefront on writing new proposed legislation for supplements. Thus it was a bit of a surprise to see where the joint statement actually came from, Greene said.
“It was interesting that the actual statement came out of Sen. Blumenthal’s office and not Sen. Durbin’s. We hope to meet with Sen. Blumenthal’s staff soon and also with Sen. Durbin’s staff,” he said. Fabricant said NPA also has plans for meetings with the Senators in the coming weeks.
There have been discussions within the industry about instituting a premarket product registry program, whether that is a beefing up of the Dietary Supplements Label Database maintained by the National Institutes of Health or another program. The key, Greene said, is that those proposals are for voluntary programs, not another layer of mandated bureaucracy.
“We don’t believe any new legislation is necessary. We should continue to ensure that the Dietary Supplement Health and Education Act is fully enforced and implemented and our hope is that this new office will do that once it is fully funded and up to speed,” he said.
Questions are always raised about the chances for passage of any legislation in a deadlocked Congress. Fabricant cautioned against a false sense of security over the legislation’s failure in the past, as the bill could easily be attached to something else with a much higher priority.
“Could they attach it to something that is a must-pass? I think in an election year that is certainly possible,” Fabricant said.