Ephedrine alkaloid supplements seized, says FDA
either containing or claiming to contain banned ephedrine alkaloids
from Pennsylvania company ATF Fitness Products.
However ATF Fitness national sales manager Frank Bedoloto told NutraIngredients-USA.com that US marshals only photographed the products, which remain in the company's warehouse in Oakmont.
The SciFit Procut and Thermogen II weight-loss products were uncovered during an FDA inspection in October 2004, together with evidence of their intended shipment to customers in Lithuania and Poland.
According to Bedoloto, the supplements were the last remaining stock manufactured before ephedra came into effect in April 2004. He said that the company had already received payment for the consignment from its overseas clients.
"I just didn't have the right documentation or 'export only' packaging to show that it was not going to come back to the US," said Bedoloto, who holds that it is not illegal for a company to have products containing the banned plant extract on its premises or to ship it to countries where it has not been outlawed.
"Over the past four months we have been working with the FDA to find out what our rights are to sell the products overseas," he added.
An FDA spokesperson had not responded to NutraIngredients-USA.com's invitation to comment on the matter prior to publication.
The Sci-Fit products were labeled as containing MaHuang extract, a source of ephedrine alkaloids which were, until April last year, promoted for weight loss and to help enhance sports performance and increase energy.
The sale of ephedra and ephedrine alkaloids in the US was prohibited by the FDA in the light of a report by the RAND Corporation, which showed that the stimulant can have potentially dangerous effects on the heart. The agency says that there is little evidence for its effectiveness other than for short-term weight loss.
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.
While supplements do not require pre-market approved from the FDA, under the Food, Drug and Cosmetic Act a dietary supplement may be removed from the market if it is found to present a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use, if no conditions of use are suggested or recommended in the labeling.
"This FDA rule reflects what the scientific evidence shows - that ephedra poses an unreasonable risk to those who use it," Health and Human Services secretary Tommy Thompson said, when the ban came into effect. He pledged to take "swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."
Concerns over ephedra actually date back further. The FDA said it had been warning consumers against using supplements containing ephedra since June 1997.
Some industry members disagree with the assessment of risk however. Neil Levin from Now Foods has argued that the ban "is based on false representations of the real safety data. Peanuts kill many times as many people as ephedra is alleged to have caused. Billions of doses a year have resulted in only a handful of possible links of ephedra to deaths, under extreme conditions."
As for ATF Fitness, Bedoloto said that if the matter cannot be handled in one small hearing it will destroy the products, since the legal process is already eating into profit it would have made from what he called "a small international order for us".
