What Is The National Standard For Ephedra?

What Is The National Standard For Ephedra?

Industry recognized that, despite the unwarranted actions of FDA, there was a need for national standards for Ephedra products. Well before FDA issued its proposal for limits on Ephedra, industry adopted guidance for its members and also introduced and supported legislation or regulations in several states to establish legal requirements for a national standard, including Ohio, Washington, Hawaii and Michigan.

The standard that the dietary supplement industry provides serving and daily intake limits, substantive and informative warnings to consumers with preexisting conditions who should not be taking Ephedra or any other stimulants, including caffeine, recommendations against use of the products by minors, and a prohibition on marketing that encourages abuse of the product by minors, such as products like “herbal ecstascy.” It is worth noting that the industry standard serving limit for herbal Ephedra is significantly lower than the FDA monograph for more potent OTC ephedrine products.

In a meeting on May 6, 1999, the major industry trade associations representing the manufacturers and distributors of Ephedra submitted proposed guidance incorporating the national standards to FDA and requested that the agency adopt these standards. The text of this guidance is as follows:

FDA REGULATORY ACTION GUIDANCE

The following represents the criteria for recommending legal action against dietary supplements containing Ephedra to FDA’s Center for Food Safety and Applied Nutrition/Office of Field Programs/Division of Enforcement:

1. If the product contains on a per serving basis more than 25mg of ephedrine alkaloids (the total of ephedrine, pseudoephedrine, norpseudoephedrine, norephedrine, methyl ephedrine, methyl pseudoephedrine and related alkaloids).
2. If the product label does not list the amount of ephedrine alkaloids per serving.
3. If the recommended daily intake specified on the product label exceeds 100mg of ephedrine alkaloids per day.
4. If the product contains xanthine alkaloids (collectively identified as caffeine) and the product label does not list the amount of caffeine per serving.
5. If the product label does not bear an adequate warning statement, which shall at a minimum include the following language, or comparable language:

   Not for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric condition, difficulty in urinating due to prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug, or if you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).

   Exceeding recommended serving will not improve results and may cause serious adverse health effects.

   Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.

6. If any claims are made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a “legal” alternative for an illicit drug.
7. If the product is marketed or offered for sale to minors.

FDA has never officially responded to industry’s proposal that the agency adopt the current national standards for Ephedra.

Related:

Blue Slim Ephedra with Ephedra 27mg

Zenatrol Ephedra Diet Pills

Ephedra 5

Hydroxytrol with 10mg Ephedrine

Suggested Reading:

1. Dietary Supplement Industry Calls On FDA To Adopt National Standards On Ephedra
2. Significant Growth In Consumption Of Ephedra Products With Few Adverse Reports
3. What Are Ephedrine Alkaloids?