Way ahead on ephedra is still not clear, say associations
products, the dietary supplements industry is still in limbo over
the previously-banned herbal, since the FDA has not yet given any
indication of its next course of action.
Three major dietary supplement trade associations - the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA) - have sent a joint letter to Lester Crawford, acting commissioner of the FDA, asking that the agency make its intentions on ephedra known as quickly as possible to clear up the widespread confusion that has resulted from the ruling.
The letter, which has been published on AHPA's website, was copied to Michael Leavitt, secretary of Health and Human Services.
On 13 April, almost exactly a year after the FDA's outright ban on all supplements containing ephedra came into effect, Judge Tena Campbell of the US District Court of Utah said that the FDA had failed to meet its burden of proof that a daily dose of 10 mg or less of ephedrine alkaloids presents an unreasonable risk of illness or injury.
She ordered the FDA to carry out a dose-dependent toxicology study before imposing a ban on ephedrine alkaloids only at and above the level shown to present a risk, and enjoined it from taking any action to block Nutraceutical, the company which brought the lawsuit, from selling supplements containing 10mg or less per daily dose.
Two days later an FDA spokesperson told NutraIngredients-USA.com that the agency interprets the ruling to means that its ban remains in effect as to higher dosages of these products, and that FDA is considering all of its options with respect to next steps. She confirmed today that the FDA has no new comment to make on the matter.
In the absence of a clear statement from the FDA, the ruling has been open to different interpretations put forward by industry commentators, legal professionals and consumers.
At the time the ruling was handed down Jonathan Emord, counsel for Nutraceutical said to NutraIngredients-USA.com: "At the moment there is no question that the ban is overturned."
The industry associations do not concur with this reading. They stress that the ruling relates only to supplements containing 10g or less per daily dose, but have nonetheless advised their members that it would be prudent to refrain from commerce in any dietary supplements containing ephedrine, whatever the dose, pending further developments.
The three bodies behind the letter are not the only organizations to warn their members against hasty reintroduction of withdrawn products. On 29 April members of the Utah Natural Products Alliance (UNPA) voted unanimously to make no sales of ephedra products a condition of membership.
Whilst not going as far as the UNPA in introducing their own outright ban, the advice issued by AHPA, CRN and NNFA seems to be heeded by their members. They said that they are not aware of any members besides the parties to the litigation that are planning to bring supplements containing ephedrine in any amount to market in the foreseeable future.
As to the wider implications on government and industry measures in place to protect consumers from potentially harmful substances, the organizations do not see the ruling as a failing by the Dietary Supplements Health and Education Act to imbue the FDA with sufficient authority.
"The ability of the FDA to remove a dietary ingredient from the market by declaring it to be a significant or unreasonable risk, and therefore adulterated…, was not questioned by the court," they wrote.
"The judge disputed the means by which the FDA made its decisions to ban ephedrine alkaloids in dietary supplements, but did not challenge the agency's responsibility and authority to deem a dietary supplement adulterated if it contains an ingredient that presents a significant or unreasonable risk under conditions of use recommended or suggested in labeling."
