Consumers rarely follow the minutiae of federal legislation, in large part because it's a slow process, and not very exciting at that.
So, there was little public awareness greeting the Food and Drug Administration's announcement that best practices would soon be coming to an industry subject to disbelief, skepticism and criticism. Good manufacturing practices requiring ingredient testing and other purity and efficacy evaluations are the surest step yet in reversing a chronic image problem, according to industry observers.
“It's good for the public and good for the industry,” said Jim Prochnow, an attorney with Greenberg, Traurig, LLP, who specializes in supplement regulations. “It will take away the perception by some people that the industry is unregulated and is putting out unsafe and unsubstantiated products with respect to claims.”
Up until now, manufacturers have been following a hybrid set of rules that was part industry consensus and part government regulation, a system that still allowed less ethical manufacturers to sell untested products of questionable safety. When it passed the Dietary Supplement Health and Education Act, Congress ordered the FDA to develop the regulations, including those covering the manufacturing process. That was 13 years ago.
“We have been encouraging them ever since then to promulgate these rules,” said Steve Mister, who heads up the Council for Responsible Nutrition, an organization representing supplement manufacturers. “This had been a long time coming. The first proposal came in 1997 and in 2003 they issued a proposed rulemaking, and since that time the industry has been nudging the FDA to get the rule out, and over the last year we have been urging Congress to put pressure on the agency.”
While everyone is taking pains to point out that the timing of the release has nothing to do with the current food safety problems involving imports and canned foods, Prochnow does see a thread connecting them.
“Clearly, the FDA has sharpened its pencils and focused on food safety, as a result of enacting DSHEA in 1994, Sept. 11 and consumer demand,” he said, adding that even with such compelling reasons, the regulatory process moves at the speed of cold molasses.
“FDA regulations, for sure, usually follow what's going on in the marketplace and demand by about 10 years,” he said. “It takes them 10 years.”
As consumers become more interested in alternative treatments for chronic conditions, supplements are expected to play an increasingly important role in their lives. Already, more attention is being paid to side effects, adverse reactions and potential contraindications with prescription medications. It's all the more reason for the FDA to quicken the pace and take steps to implement other areas of DSHEA.
“I think this final rulemaking is a tremendous step forward,” said Mister. “It sets standards, raises the bar and tells manufacturers these are the rules you must live by to make these products, and now, with the FDA enforcing, it will get rid of outliers on the fringe.”