This is an explanation of the differences between over-the-counter("OTC") bronchodilator/expectorant drug products containing ephedrine hcl and dietary supplements that contain ephedra, ephedrine alkaloids, or ephedrine. As explained below, the differences are substantial and the FDA's decision to prohibit the sale of dietary supplemetns containing ephedrine has absolutely no impact on a company's ability to market and sell OTC drug products containing ephedrine hcl. The most noticeable difference between the two products is that ephedrine hcl drug products contain "Drug Facts" boxes and ephedra/ephedrine dietary supplement products contain "Supplement Facts" boxes. Only those products that contain "Supplement Facts" boxes will be affected by the FDA's decision to prohibit the sale of ephedra/ephedrine dietary supplements.
The Federal Food, Drug and Cosmetic Act("FFDCA") and US Food and Drug Administration("FDA") regulations treat dietary supplements and OTC drug products differently.
Dietary Supplements are not formally recognized as safe and effective by the Agency. OTC drug products may only be marketed if the FDA has recognized the products as safe and effective.
"Ephedra" is the commonly used name for a dietary supplement containing ephedrine alkaloids or naturally occuring ephedrine. It was sold as a raw botanical or as an extract from botanical sources, and it is also known by other names, such as Ma Huang and Chinese Ephedra. The raw botanical or extract naturally contains the following alkaloids(among others): ephedrine, pseudoephedrine, norpseudoephedrine, norephedrine, methylephedrine, and methylpseudoephedrine. Because ephedra was sold as a "dietary supplement," it was marketed without the FDA's concurrence or approval and could not be removed from the market until such time that the FDA found that it posed a significant or unreasonable risk of harm.
In contrast, OTC drug products that contain ephedrine hcl are specifically marketed pursuant to the FDA's "Final Monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for OTC Human Use"("Final Monograph"). The Final Monograph identifies certain ingredients that the FDA has determined are "generally considered as safe and effective" for particular uses and sets forth specific rules regarding labels that, when complied with, permit a company to market one of those ingredients. The inclusion of ephedrine hcl in the Final Monograph represents a finding by the FDA that ephedrine is generally recognized as safe and effective when labeled in accordance with the monograph. Moreover, ephedrine hcl has never been marketed as a dietary supplement, nor could any claims regarding weight loss or energy have been made for products containing ephedrine hcl. To do so, would have caused the product to be considered an unapproved new drug by the agency.
FDA has announced its attention to prohibit the sale of ephedra dietary supplements- not ephedrine hcl OTC drug products.
FDA has announced its intention to prohibit the sale of dietary supplement products that contain ephedra, ephedrine alkaloids, and ephedrine because of perceived concerns over their safety. This announcement was based on FDA's analysis of perceived risks associated with ephedra products, including (1) a study by the RAND Corporation allegedly suggesting health risks associated with ephedra: (2) the available evidence suggests that their is a "significant or unreasonable risk of illness or injury" associated with consumption of ephedra: (3) a new warning label would not mitigate that risk.
More importantly, this action pertains only to dietary supplements that contain ephedra, ephedrine alkaloids, or ephedrine. This decision does not reflect, in any way, FDA's view of the safety of ephedrine hcl bronchodilator drug products. Indeed, the FDA's decision does not affect the regulatory status of OTC bronchodilator products containing ephedrine hcl in the United States and the ability to market these products in the United States.
Conclusion:
Because ephedra dietary supplements and ephedrine hcl OTC drug products are subject to entirely separate legal and regulatory regimes, FDA's decision to ban ephedra dietary supplements has absolutely no impact on the status of OTC ephedrine hcl drug products, and companies are free to market and distribute OTC ephedrine hcl drug products.
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