The US dietary supplements industry must improve its manufacturing and marketing processes, police itself more stringently and become more transparent when reporting adverse events if the Food and Drug Administration's ban of ephedra is not to spell the end of the Dietary Supplement and Heath Education Act, according to leading industry figures.
The ephedra furore has become a catalyst for the growing band of critics who for some time have been calling for the liberal 10-year-old legislation to be amended or dismantled. Prominent Michigan Congressman John Dingell has stated he "would like to repeal the whole sorry mess" and many in the industry are preparing for just such an eventuality.
FDA commissioner Mark McLellan told The New York Times that ephedra "was just the tip of the iceberg," noting the agency had issued 75 warning letters to supplement manufacturers, 500 per cent more than in 2002—before he took office. It had also seized millions of dollars worth of illegal supplements.
Bitter orange and aristolochic acid are just two ingredients that have come under FDA scrutiny post-ephedra. Industry groups such as the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association and the American Botanical Council (ABC) have stated they would not oppose a ban of aristolochic acid.
This flurry of activity is exactly what responsible sections of the industry, keen to crack down on unscrupulous operators, have long sought from the FDA. It is not DSHEA that is the problem, they say, but FDA's inability to police it.
Seen in this light, ephedra could well represent DSHEA's saviour rather than its demise, especially if the Hatch-Harkin bill is passed, which will grant the FDA an additional $20-30 million annually to fully enforce all of the safety provisions written into DSHEA.
"For years, some have said that DSHEA has tied FDA's hands from being able to effectively protect the public from unsafe dietary supplements," said Mark Blumenthal, ABC's founder and executive director. "The ephedra ban can be used as evidence that this is not true."
"The controversy about the safety of ephedra has led to much doubt about the safety of dietary supplements," said John Hathcock, PhD, vice president for scientific and international affairs at CRN. "Some of those doubts are legitimate, so getting ephedra resolved is a good thing for the industry. Now the FDA must go ahead and enforce the safety provisions that exist in DSHEA."
If the wheel is to undergo some form of reinvention, Loren Israelsen and Thomas D Aarts, writing in Nutrition Business Journal, highlighted three DSHEA provisions that must be fought for:
- the definition of dietary supplements
- the provision that dietary supplements are not food additives
- the provision that the FDA has the burden of proof to prove a product is unsafe before it can remove it from the market.
Without these tenets a situation may arise, according to Blumenthal, where products are removed "that have the appearance of toxicity based on erroneous information. This might happen as a result of Congress' passage of various measures that are driven more by emotion than science."