American Generic Laboratories announced yesterday that it has launched four new ephedra-based supplements. It said the move was in response to high consumer demand, and that it hopes to capture back the 14 to 17 million Americans it says were using ephedra prior to the FDA's final rule banning the herb in supplements in 2004.
In April 2005, a Utah judge ruled that the FDA failed to prove that a daily dosage of 10mg or less of ephedra presents an unreasonable risk of illness or injury.
Judge Teena Campbell ordered the FDA to carry out a dose-dependent toxicology study and impose a ban on the herbal's use only at and above the level at which it is found to produce toxicity. She also enjoined the government agency from taking any enforcement action to block Nutraceutical Corp, which brought the action, from selling supplements containing 10mg or less of ephedrine alkaloids per daily dose.
The FDA is appealing the court decision.
In the meantime, American Generic Laboratories has interpreted the ruling to mean that ban was "erroneous" in the first place, and that the ruling overturns it.
However this analysis differs wildly from that of trade association the American Herbal Products Association (AHPA).
President Michael McGuffin told NutraIngredients-USA.com that he does not read the ruling as overturning the ban on ephedra, but merely preventing the FDA from taking any action against Nutraceutical Corp.
This interpretation means that any other company wishing to reintroduce ephedra products will have to first approach the court for the go-ahead.
American Generic Laboratories said that the dose of ephedra contained in its new products, which are sold only online, are within legal limits. NutraIngredients-USA.com was unable to verify the exact dose since the company releases no contact information.
AHPA and the two other main industry associations, the National Nutritional Foods Association (NNFA) and the Council for Responsible Nutrition (CRN), have advised companies not to relaunch ephedra products - even at a dose of less than 10mg - until the FDA position is clear.
As to the effect it will have on the industry, McGuffin said: "Will it have a short term benefit for one company? Possibly. But it is certainly not good for the trade."
"This gives our critics ammunition."
Some lawmakers believe that the dietary supplements industry should be subject to the same regulations as pharmaceutical drugs. But the industry associations have frequently and vociferously defended the 1994 Dietary Supplement Health and Education Act as a good law.
A report carried out by the RAND Corporation prior to the initial ban suggested that it could have potentially dangerous effects on the heart. Other studies have also indicated that ephedra use raises blood pressure and otherwise stresses the circulatory system, which could lead to heart disease and stroke.
The FDA has said that there is little evidence for the herbal's effectiveness other than for short-term weight loss.