Regulatory triumphs and disappointments for 2006
regulatory successes and failures have been for the industry in
2006.
The resounding triumph has been the passing of the relating to adverse events reporting (AER) in the House of Representatives last week. Whereas regulations governing Good Manufacturing Practices still hang in the balance, leaving industry frustrated.
Both regulatory measures relate to the dietary supplement industry's quest for more credibility in light of critics who say the industry is unregulated.
"AERs and GMPs are the most critical regulations for the industry," vice president scientific and regulatory affairs with the Council for Responsible Nutrition, Andrew Shao, told NutraIngredients-USA.com. "They are the missing pieces of the puzzle that can change how people perceive the dietary supplement industry."
The industry has been dogged by what it perceives is the mainstream media's sensationalizing of rare cases in which supplements make flagrantly misleading claims to consumers. As such, associations have sought to protect the reputation of the industry.
"The ironic thing is that the responsible companies in this industry already manufacture to this standard or above it," said Shao.
That bill would require supplement labels to include a telephone number for the reporting of serious advert events, and require supplement companies to pass on these reports to FDA within 15 days.
The House passed the Dietary Supplement and Non-Prescription Drug Consumer Protection Act on adverse events reporting shortly after the bill was passed unanimously by the Senate.
The bill is designed to amend the federal Food, Drug and over-the-counter drugs to the United States Food and Drug Administration (FDA).
"The biggest policy success this year was the passing of the AER bill just 15 minutes before the House of Representatives convened for the year," Natural Products Association executive director David Seckman told NutraIngredients-USA.com.
The passage of the bill represents a victory for dietary supplement trade associations, after many of them lobbied for months. The bill was the last action voted on by the 109th Congress - coming through just minutes before the House adjourned.
Existing legislation has drawn criticism because it does not require the same pre-market approval for supplements as for prescription drugs. The dietary supplements industry is regulated by DSHEA, the 1994 Dietary Supplements Health and Education Act. If signed by President George W. Bush, the AER bill would represent the first amendment to DSHEA.
However, according to Shao, the AER bill is more symbolic in its importance and is not likely to have a drastic effect on the day-to-day operations of most companies.
"Larger companies already have information collecting systems in place," said Shao. "So for them AERs are merely a date passing."
Shao added that the regulatory measure would likely force some smaller companies to get up to speed on their manufacturing practices. He said companies can do this by enlisting the help of consulting firms.
While the industry is applauding AER legislation, it appears it will see yet another year go by without any firm answer on when Good Manufacturing Practices will be in place.
"I would say the biggest disappointment is that it is the end of the year and we still have answer on GMPs," said Seckman.
Good Manufacturing Practices (GMPs) form part of DSHEA and are the final piece of the puzzle before this law governing the supplements industry is fully implemented.
"GMPs would allow enforcement to then level the playing field for the few bad actors out there." said Shao. "There is a similar scenario with AERs."
The 12-year wait has been a source of frustration to the industry, who has badgered FDA all along to get the guidelines materialized.
