CONCERNS OVER PPA ARE NOT RELEVANT TO EPHEDRA

The public health concerns that led FDA to ask all companies to discontinue marketing drug products that contain phenylpropanolamine (PPA) are not relevant to the ongoing review of the benefits and safety of dietary supplements that contain ephedra.

FDA'S DECISION ON PPA

• PPA has been marketed for decades as an over-the-counter ingredient in widely consumed cold medications and appetite suppressants, at individual doses of up to 25 mg taken 6 times per day (excluding extended release formulations, which use higher amounts).
• FDA has requested that companies cease marketing products containing PPA based on the availability of alternative ingredients, FDA's perception that benefits of PPA for colds and appetite suppression are extremely limited, and the agency's belief, based on a controversial study and a relatively small number of reports of possible adverse events, that PPA may cause a slight increase in hemorrhagic stroke - a serious adverse effect that is not associated with alternatives to PPA.
• FDA's request at this time is for voluntary industry action - FDA has yet to issue a proposed rule that establishes a valid scientific basis for the agency's request, and there is considerable question as to whether FDA can provide support for such a regulation.

PPA IS NOT RELEVANT TO EPHEDRA

• PPA is a natural but very minor constituent found in some, but not all, dietary supplements containing ephedra.
• When present at all, PPA is present in amounts that are approximately 100-fold or more lower than the amount of PPA found in popular OTC cold products.
• In addition, small amounts of the naturally occurring ephedrine that is present in supplements that contain ephedra may be converted to PPA in the body, but current data suggest that the conversion is no more than 4 to 6 percent, which would result in approximately 0.5 to 1.5 mg of PPA per serving from this source.
• FDA has not questioned the safety of OTC ephedrine, which contains more ephedrine (resulting in more consumer exposure to PPA) than found in ephedra products, presumably because the amounts from metabolic conversion are so small as to be insignificant.
• These facts show that any exposure to PPA from consuming ephedra products is minimal at most.
• This minimal exposure led a seven-member expert panel, which in July through September of this year subjected ephedra products to the most comprehensive review of ephedra ever, to conclude that PPA is not relevant to ephedra safety.