The identity of Super Heavy Dog cannot be revealed due to his ties to competitive organizations, endorsements, affiliations and consulting status in the vitamin and supplements industry.
The never- ending –questions it seems. Is it legal or illegal? Is
Ephedra banned or not banned? It is never been very clear since the debate began in the late 90’s. Here is what I do know as of today:
- Ephedrine and Ephedra are still banned when you talk to the FDA on the phone. I know this because I called.
- A few companies stood up to the FDA and have sold it all along – Hi Tech Pharmaceuticals and Bio-Tek. Despite smear campaigns by other companies about fines and pending incarceration, the owners of the companies are sitting in their offices fulfilling order for Ephedra and Ephedrine HCL right this minute.
- I don’t know. There has been no formal announcement by the FDA thus far. The reason the “big companies” are not touching it is because of insurance.
- I found the following released information very interesting:
On February 6, 2004, the FDA announced that it was publishing a final rule declaring all dietary supplements containing
Ephedrine Alkaloids adulterated. The final rule was published on February 11, 2004, and became effective sixty days later, on April 12, 2004.
In the final rule, the FDA concluded that dietary supplements containing
ephedrine alkaloids are adulterated because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling or, if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. To reach this conclusion, the FDA considered numerous studies and data related to the safety of dietary supplements containing
ephedrine alkaloids. The data came from three principal sources: (i) the pharmacology of ephedrine alkaloids; (ii) scientific literature on the effects of ephedrine alkaloids; and (iii) adverse events that occurred in individuals who consumed dietary supplements containing
ephedrine alkaloids.
Under the Food, Drug, and Cosmetics Act (FDCA), the Food and Drug Administration (FDA) is provided broad authority to regulate food, drug and dietary supplement products to ensure public health and safety. In 1994, congress amended the FDCA to include Dietary Supplement Health and Education Act. (DSHEA), which authorizes the FDA to prevent “adulterated” dietary supplements from entering the market. Pursuant to DSHEA, a dietary supplement is “adulterated” if it “presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.” 21 U.S.C. / 342(f)(1)(A).
After examining the data, the FDA determined that dietary supplements containing
ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death. It further concluded that those risks were unreasonable in light of the modest, short-term benefits from using such products. The FDA also noted that it had not been presented with sufficient evidence to establish a safe dose of
Ephedrine or ephedrine alkaloids. Because no such dose could be identified, the FDA determined that even minimal amounts of ephedrine alkaloids present unreasonable risks and should not be allowed on the market.
The six principle
Ephedrine alkaloids that are pharmacologically active in botanicals include ephedrine, pseudoephedrine, norephedrine, methylephedrine, norseudoephedrine and methylpseudoephedrine. Each of these alkaloids is included in the ban.
The FDA made clear, however, that several products are not included in the ban. For instance, the prohibition does not apply to conventional food products that contain
Ephedrine alkaloids. The final rule also does not apply to over-the-counter drugs or prescription drugs containing ephedrine alkaloids.
Moreover, the final rule does not indicate that
Ephedrine alkaloid-free dietary supplements are included in the ban. Nor does the FDA indicate that there is any evidence that ephedrine alkaloid-free products present significant or unreasonable risks. Thus, ephedrine alkaloid-free dietary supplements do not appear to be affected by the final rule. Indeed, the FDA noted that most North American species of Ephedra do not contain ephedrine alkaloids and, therefore, excluded them from the ban.
THE SUMMARY: The question presented, was whether the Food and Drug Administration’s final rule prohibits the sale of
Ephedra Diet Pills that do not contain ephedrine alkaloids? To answer the question, simply, the final rule applies to all dietary supplements that contain ephedrine alkaloids. Ephedrine alkaloid-free dietary supplements do not appear to be included. Therefore, assuming it is possible to make a dietary supplement from ephedra, which contains no ephedrine alkaloids, it appears that such a product would not be subject to the Final rule.
Written By Brian Bemis, Contributing Author
