Food & Drug Administration on ephedra

Ephedra Ban - Final Rule (Summary)

FDA's Q&A on Ephedra: Questions and Answers about FDA's Actions on Dietary Supplements Containing Ephedrine Alkaloids

Sales of Supplements Containing Ephedrine Alkaloids (Ephedra) Prohibited

FDA News: FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products

December 30, 2003:
FDA Consumer Alert: The FDA plans to prohibit the sale of products containing ephedra.  It urges consumers to stop buying and using these products immediately.

FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra

FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra (Dept. of Health & Human Services - similar to the FDA's)

FDA letter to ephedra product manufacturers: FDA intends to publish a rule in the coming weeks that finds that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling of the product, or, if no conditions of use are suggested in the labeling, under ordinary conditions of use, and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act). This rule will become effective 60 days after publication so as to allow for congressional review in accordance with 5 U.S.C. 801-808.

Companies Marketing Ephedra Dietary Supplements that Received FDA's Letter Dec. 30, 2003

October 28, 2003:
Statement of John M. Taylor, Associate Commissioner for Regulatory Affairs at the Food and Drug Administration before the committee on commerce United States Senate

 

February 28, 2003:
	Department of Health and Human Services (HHS) Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra
	HHS Acts to Reduce Safety Concerns Associated with Dietary Supplements Containing Ephedra
	Evidence On The Safety And Effectiveness Of Ephedra: Implications For Regulation
	Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects

The 'Supplements Associated with Illnesses and Injuries' page from the FDA states:

Ephedra (also known as Ma huang, Chinese Ephedra and epitonin) Possible Health Hazards: ranges from high blood pressure, irregular heartbeat, nerve damage, injury, insomnia, tremors, and headaches to seizures, heart attack, stroke, and death

The following links were taken from: FDA/CFSAN Products that Consumers Inquire About - ephedra

• Ephedra or Ephedrine

• Dietary Supplements: Ephedrine Alkaloids

• Supplements Associated with Illnesses and Injuries

• An FDA Guide to Dietary Supplements

• Dietary Supplements

• Products That Consumers Inquire About

• Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information

• Proposed Rule: Dietary Supplements Containing Ephedrine Alkaloids             (Federal Register June 4, 1997)
  
  Docket No. 95N-0304
  The Food and Drug Administration (FDA) is proposing to make a finding, which will have the force and effect of law, that a dietary supplement is adulterated if it contains 8 milligrams (mg) or more of ephedrine alkaloids per serving, or if its labeling suggests or recommends conditions of use that would result in intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more of ephedrine alkaloids; require that the label of dietary supplements that contain ephedrine alkaloids state "Do not use this product for more than 7 days"; prohibit the use of ephedrine alkaloids with ingredients, or with ingredients that contain substances, that have a known stimulant effect (e.g., sources of caffeine or yohimbine), which may interact with ephedrine alkaloids; prohibit labeling claims that require long-term intake to achieve the purported effect (e.g., weight loss and body building); require a statement in conjunction with claims that encourage short-term excessive intake to enhance the purported effect (e.g., energy) that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death"; and require specific warning statements to appear on product labels. FDA is proposing these actions in response to serious illnesses and injuries, including multiple deaths, associated with the use of dietary supplement products that contain ephedrine alkaloids and the agency's investigations and analyses of these illnesses and injuries. FDA is also incorporating by reference its Laboratory Information Bulletin (LIB) No. 4053, that FDA will use in determining the level of ephedrine alkaloids in a dietary supplement.
  

• Overview of Dietary Supplements 

  In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content. 

   

• FDA Proposes Safety Measures for Ephedrine Dietary Supplements            (Press release June 2, 1997) 
  
  The proposal would prohibit the marketing of dietary supplements containing 8 milligrams or more of ephedrine alkaloids per serving. Labeling that recommends or suggests conditions of use that would result in an intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more also would not be allowed. In addition, the proposal would require label statements instructing consumers not to use the product for more than 7 days, and would not allow label claims for uses for which long-term intake would be necessary to achieve the purported effect. These safety measures are based on the fact that long-term intake of ephedrine alkaloids increases the likelihood of serious adverse events. Another measure in the proposal would apply to products with claims that encourage short-term excessive intake to enhance the claimed effect, such as energy enhancement. Such products would be required to bear a labeling statement that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death." The proposal also would prohibit the use of other stimulant ingredients such as botanical sources of caffeine with ephedrine alkaloids because the combination increases the stimulant effects of ephedrine alkaloids and the chance of consumer injury.
  
  

• FDA Statement on Street Drugs Containing Biological Ephedrine             (Press Release, April 10, 1996) 
  
  The Food and Drug Administration is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstacy," because these products pose significant health risks to consumers. These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart...
  
  

• Minutes of the Special Working Group on Food Products Containing Ephedrine Alkaloids (FDA Food Advisory Committee, Oct 11-12, 1995) 
  
  Recaps a public meeting regarding the potential public health problems associated with dietary supplements and other food products containing botanical ingredients that are sources of ephedrine alkaloids. The meeting discussed adverse event reports and the chemistry of the plants used and on an FDA review of products in the marketplace, traditional use of botanical materials in Chinese herbal medicine, adverse events associated with foods in the State of Texas, dietary supplements and drugs containing ephedrine alkaloids, the consequences of rapid weight loss, expected reactions from consumption or administration of ephedrine alkaloids.
  
  

• FDA Warns Consumers Against Nature's Formula One                        (February 22, 1995) 
  
  The Food and Drug Administration warned consumers not to purchase or consume Nature's Nutrition Formula One products (sold by Alliance U.S.A. of Richardson, Texas) labeled as containing Ma Huang (ephedrine) and kola nut because the product poses a risk to consumers' health. The warning does not apply to the reformulated version of the product which removed the kola nut.
  
  

• Adverse Events with Ephedra and Other Botanical Dietary Supplements         (FDA Medical Bulletin, September 1994)   
  
  The FDA received increasing numbers of reports of adverse events associated with the use of products marketed as dietary supplements for weight loss, energy, and ergogenic (performance-enhancing) and body-building purposes, often contain a number of similar ingredients, including Ma huang (Ephedra sinica or Chinese ephedra, a botanical source of ephedrine, pseudoephedrine, and norpseudoephedrine), guarana or Kola nut (caffeine sources), white willow (salicin source), and chromium. They are touted for their reported stimulant effects (pep or energy) and their ability to enhance metabolism with subsequent weight loss  (so-called "fat burners").