Despite Ban, Ephedra Will Remain In Common Cold-Flu Medications
Wednesday January 7, 2004
Despite the FDA's upcoming ban on ephedra in diet supplements, high doses of its active ingredient will remain in many over-the-counter drugs used by millions of Americans every day...
according to Rob McCaleb, a natural product consultant with the international law firm of Greenberg Traurig LLP and founder and president of the Herb Research Foundation.
"Even after the proposed ban takes effect, anyone, even children, will be able to walk into a drug store, grocery or even convenience store and buy FDA- approved 'safe and effective' products consisting of heavy doses of ephedrine. This includes some of the biggest and most profitable over-the-counter products on the shelves of every major pharmacy in the country," said McCaleb.
Ephedrine, used in over-the-counter drugs for treating asthma and congestion, and pseudoephedrine, used as a nasal decongestant, are the two main compounds in the plant ephedra, or Ma Huang, which has been used for these purposes since long before modern science or medicine was conceived.
"The proposed ban has the potential to affect the nation's leading pharmaceutical companies, who will have to protect those products from a domino-effect ban," said attorney Jim Prochnow, a shareholder of Greenberg Traurig. Prochnow regularly teams with McCaleb on drug and supplement projects worldwide. "Both supplement and over-the-counter drug manufacturers are staring into the abyss of the loss of a major ingredient." Prochnow has represented numerous diet supplement companies over the last 13 years.
"There were two major OTC decongestants. One, PPA (phenylpropanolamine), fell a few years ago for safety reasons. It was the major active ingredient in leading cold medications. Now there is just one, pseudoephedrine," he said.
"The FDA has decided that it is willing to go to court to maintain that the Dietary Supplement Health and Education Act of 1994, the industry's and the public's 'Bill of Rights' with respect to food supplements, empowers the FDA to ban or declare 'unsafe' an entire class of substances rather than having to proceed on a product-by-product basis."
The FDA has stated that consumers should not take ephedrine alkaloids because they are unsafe (in supplements). Yet, the FDA allows their use in OTC drugs.
"The FDA is in an untenable position from a toxicological standpoint," said Prochnow. "Generally, 25 mg of ephedrine has the same safety and the same risk if taken for weight loss or asthma. It's either too dangerous for consumers to self-medicate with, or it is not. We are evaluating the FDA's position and the possible impact of this decision on other supplement ingredients, because this may signal new risks for the industry and for the public's right to access self-care health products."
"Even after the proposed ban takes effect, anyone, even children, will be able to walk into a drug store, grocery or even convenience store and buy FDA- approved 'safe and effective' products consisting of heavy doses of ephedrine. This includes some of the biggest and most profitable over-the-counter products on the shelves of every major pharmacy in the country," said McCaleb.
Ephedrine, used in over-the-counter drugs for treating asthma and congestion, and pseudoephedrine, used as a nasal decongestant, are the two main compounds in the plant ephedra, or Ma Huang, which has been used for these purposes since long before modern science or medicine was conceived.
"The proposed ban has the potential to affect the nation's leading pharmaceutical companies, who will have to protect those products from a domino-effect ban," said attorney Jim Prochnow, a shareholder of Greenberg Traurig. Prochnow regularly teams with McCaleb on drug and supplement projects worldwide. "Both supplement and over-the-counter drug manufacturers are staring into the abyss of the loss of a major ingredient." Prochnow has represented numerous diet supplement companies over the last 13 years.
"There were two major OTC decongestants. One, PPA (phenylpropanolamine), fell a few years ago for safety reasons. It was the major active ingredient in leading cold medications. Now there is just one, pseudoephedrine," he said.
"The FDA has decided that it is willing to go to court to maintain that the Dietary Supplement Health and Education Act of 1994, the industry's and the public's 'Bill of Rights' with respect to food supplements, empowers the FDA to ban or declare 'unsafe' an entire class of substances rather than having to proceed on a product-by-product basis."
The FDA has stated that consumers should not take ephedrine alkaloids because they are unsafe (in supplements). Yet, the FDA allows their use in OTC drugs.
"The FDA is in an untenable position from a toxicological standpoint," said Prochnow. "Generally, 25 mg of ephedrine has the same safety and the same risk if taken for weight loss or asthma. It's either too dangerous for consumers to self-medicate with, or it is not. We are evaluating the FDA's position and the possible impact of this decision on other supplement ingredients, because this may signal new risks for the industry and for the public's right to access self-care health products."
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