As the ephedra crisis deepens in the US, the supplements industry is bracing itself for a 'full-scale legislative assault' on the ten-year-old Dietary Supplement Health and Education Act (DSHEA), as an increasing number of government members begin to question the industry's ability to self-regulate. A federal bill (The Dietary Supplement Safety Act) to amend DSHEA, introduced in March, is causing concern about how long the current legislative structure can remain.
A poll taken during a recent high-level meeting of senior industry executives in San Diego, California, found 79 per cent thought the industry should prepare for an amendment to DSHEA (See below).
Capitol Hill hearings in July recommended an outright ban on ephedra as well as further amendments to DSHEA that would expand the powers of the FDA to regulate the supplements industry. These have been set out in a bill, introduced in August, the DSHEA Full Implementation and Enforcement Act, which will boost FDA funding. FDA commissioner Mark McClellan, MD, PhD, said it was difficult for the FDA to take action against potentially dangerous products under DSHEA as it stood.
"If this bill is passed, the FDA will have no more excuses for inaction. It will also put to rest the idea that Congress and the industry don't want to see DSHEA fully implemented," said the National Nutritional Foods Association executive director and CEO, David Seckman.
When DSHEA became law in 1994, it was celebrated as a revolutionary piece of legislation that would allow the US supplements industry to achieve maximum innovation with minimum government intervention. The intended result was ultimate variety in consumer choice.
But ultimate variety has meant an industry that is difficult to police. Ephedra has highlighted this situation and led to calls from legislators, some industry observers and consumer groups for the Act to be revised—or scrapped completely. Ephedra has been linked to 100 deaths including a high-profile professional sportsman, which has made it a very public issue, especially when it was revealed that, in addition, 16,000 reports of serious side effects were not acted upon.
So is this the end of self-regulation? San Diego-based Nutrition Business Journal editor, Grant Ferrier, insists the industry must demonstrate to regulators why self-regulation can work, despite ephedra. "The industry has sustained vague threats in the past but the ephedra safety issue seems to have been the proverbial last straw to tip Congress into action and the industry into serious response mode. There is a sense that if industry doesn't come forward and participate with real solutions, government will dictate new market conditions that may be difficult for business."
Even a more vigilant FDA may not be enough to save DSHEA, said the NNFA's Seckman. "Even if the FDA bans ephedra tomorrow, which we believe it has the ability to do under the law, I believe there's already too much momentum in Congress to avoid a full-scale legislative assault on DSHEA," he said.
Nestlé Nutrition Division's vice president of new business, Steve Allen, was less dire. "We'll see more enforcement and specific action against rogue companies and dubious products but I don't think DSHEA is really at risk."
An FDA verdict on ephedra was imminent as FI went to press.
Industry leaders: What they're saying
Top-level executives were polled at the recent NBJ Newport Summit in San Diego
63% believe the industry will be ephedra-free by January 2004
67% support a national ban
79% think the industry must be prepared for legislative amendments
63% would support an 'intermediate' regulatory status for herbs (between DSHEA-supplements and drugs)
54% said they had more confidence in this sector than any other going forward to 2005
69% support a separate regulatory status like Japan's FOSHU
Negative Media Coverage
73% say the best way to respond is to clean up product quality and claims and self-police more effectively
57% claim research is extremely important
61% say most companies wait for others to fund research, pursuing a 'me-too' product strategy
56% spend more than 6% of net sales revenue on scientific studies to prove product efficacy
29% spend less than 1% of net sales