Federal Government to Ban Ephedra in U.S. January 1, 2004

Wow, I live in a world where more people die of alchohol, cigarrettes, and sales of over the counter drugs than ephedra but because of the incredible spin off and bad press, ephedra is being banned. Before the FDA got into it, Illinois, New York, and California had decided to ban ephedra (ma huang, ephedrine). Why, because of a few instances of people who claim that ephedra has contributed to the deaths or injuries of people. If only the supplement companies contributed enough money like the phrmaceutical companies do to the Congress, we wouldn't be having the ban. By April 2004, the only epehdra you will see if the stockpiles of product that many ravid hardcore users have put in their house, as ephedra was easily proven to be one of the most effective weight loss products. But due to many people overdosing or using the product wrong, the public opinion was quite negative on the product. Add to it a high profile case, like Steve Belcher, which everyone associated with him blamed his death on ephedra, and you get all the negative publicity needed for the FDA to act. However, they always, as usual, neglect to tell everyone that, in the case regarding Steve Belcher, the Baltimor Orioles pitcher, a forensic investigation conducted by former New York City Medical Examiner Dr. Michael M. Baden concluded that "Xenadrine did not cause or contribute to Mr. Bechler's death." At the time of his death, Mr. Bechler weighed approximately 320 pounds and on February 16, when Mr. Bechler collapsed on the playing field and later died of heat stroke, the temperature on the field was 81 degrees and the humidity 75 percent. Based on these facts, Dr. Baden concluded that Mr. Bechler "died of a heat stroke precipitated by his morbid obesity, high blood pressure and heart disease, adverse weather conditions, physical exertion, and inadequate screening, monitoring and medical supervision." Funny how they forget to mention this when they scream that he died because of Xenadrine and ephedra. Never the less, ephedra will be gone in three months or so. Here is the Consumer Alert that the FDA issued on December 30th, 2003, which advises consumers to stop using ephedra products and warning manufacturers that the days of ephedra will be gone soon. Consumer Alert: FDA Plans Regulation Prohibiting Sale of Ephedra-Containing Dietary Supplements and Advises Consumers to Stop Using These Products The Food and Drug Administration (FDA) is alerting the public to its forthcoming determination that dietary supplements containing ephedra present an unreasonable risk of illness or injury, and should not be consumed. The agency has notified firms manufacturing and marketing these products that it intends to issue a final rule prohibiting their sale, which will become effective 60 days after its publication. The FDA has taken this step after conducting an exhaustive and highly resource-intensive process required under the Dietary Supplement Health and Education Act (DSHEA) of 1994 for banning a dietary supplement that presents a significant and unreasonable risk to human health. To meet this challenging standard, the FDA gathered and thoroughly reviewed a prodigious amount of evidence about ephedra's pharmacology; clinical studies of ephedra's safety and effectiveness; newly available adverse events reports; the published literature; and a seminal report by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency's request in February, 2003 for information about ephedra-associated health risks. The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes. By informing more than 60 dietary supplement firms about the upcoming final rule, FDA is sending a strong and unambiguous signal that dietary supplements containing ephedrine alkaloids present an unreasonable risk. Consumers are urged to stop buying and using these products immediately. Ephedra, also called Ma Huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy. Today's announcement is a continuation of a process that started in June, 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than 7 days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products. These measures have prompted voluntary compliance with FDA rules, voluntary product recalls, FDA warning letters, seizures and injunctions, criminal actions, and joint enforcement actions with the Federal Trade Commission and the Department of Justice. As a result, ephedra-containing dietary supplements advertised for enhanced sport performance have been removed from the market, there has been a significant decline in the demand for ephedra products, and many firms have stopped their marketing. Additional information relating to today's announcement is available online at www.cfsan.fda.gov/~dms/ds-ephed.html. Here is the letter that the Department of Health and Human Services, Food and Drug Administration, has sent out by certified letter to various manufacturers, around December 30th, 2003. Dear Sir or Madam: This letter concerns your product [PRODUCT NAME], which appears to be marketed as a dietary supplement. The product labeling indicates [NAME OF BOTANICAL], a botanical source of ephedrine alkaloids, as an ingredient. 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. You can find the Act and its implementing regulations through links on FDA's Internet home page at www.fda.gov. The preamble to the rule will contain a detailed explanation of the agency's basis for its determination. The purpose of this letter is to give you advance notice of the publication of this rule to facilitate your earliest compliance. FDA intends to begin enforcing the rule as soon as it becomes effective. Sincerely yours, Joseph R. Baca, Director, Office of Compliance Center for Food Safety and Applied Nutrition Here is the list of companies that recieved the letter from the FDA on December 30th. Obviously, some of these companies that recived letters have already stopped making any type of ephedra product before the end of 2003. If they missed you, that just means that you couldn't even get noticed by the FDA. Oh well... They include Advanced Nutrient Science International; 10540 72nd St; Largo, FL 33777 Advanced Pharmaceutical Research; 732 Circle Drive; Aberdeen, SD 57401 Advanced Scientific Nutrition, 1813 Cascade Ave, Hood River, OR 97031 AFS Labs/S&K Labs, 2637 East Atlantic Blvd, Pompano Beach, FL 33062 Alpha Pharmaceuticals, Inc.. 3225 S. McLeod Drive, #100. Las Vegas, NV 89121 Alternative Pharmaceuticals/Lion Products, 400 3rd St, Red Oak, IA 51566 AST Sports Science, 120 Capital Drive, Golden, CO 80401 Betastatin Nutritional Research, LLC, 1187 Washington St, Toms River, NJ 08753 California Advanced Laboratories, 96 Inverness Dr. East #R, Englewood, CA 80112 Carter Reed Competition Nutrition, 11 Bowman Lane, Commack, NY 11725 Cytodyne Technologies, 2231 Landmark Place, Manasquan, NJ 08736 D & A Nutrition, Inc., 2017 West Pensacola St, Tallahassee, FL 32304 D&E Pharmaceuticals, Inc., 206 Macopin Rd, Bloomingdale, NJ 07403 Dymatize Nutrition, 3200 Commander, Suite 110, Carrollton, TX 75006 EAS, 555 Corporate Circle, Golden, CO 80401 Elation Therapy, 2912 Perrington Way, Marietta, GA 30066 Envision Research, 2275 Huntington Drive, #405, San Marino, CA 91108 Extreme Labs, 4440 S. Maryland Pkwy, Suite 208a, Las Vegas, NV 89119 Genna Pharm, Inc, 110 Woodland Trl, Leander, TX 78641 German American Technologies, 123 Downs Ave, Stamford, CT 06902 Higher Power, 361 Steelhead Way, Boise, ID 83704 Hi-Tech Pharmaceuticals, 5875 Jimmy Carter Blvd #720, Norcross, GA 30071-2955 IDS Sports, 572 S. Econ Circle, Suite 120, Oviedo, FL 32765 Kaizen, Inc., 11944 South La Cienega Blvd, Los Angeles, CA 90250 Klein Laboratories, 47 Capital Drive, Wallingford, CT 06492 Klein-Becker/Basic Research, 5742 W. Harold Gatty Drive, Salt Lake City, UT 84116 Mass Quantities, 1010 Northern Blvd, Suite 208, Great Neck, NY 11021 Maximum Nutrients, 2005 South Division Ave, Grand Rapids, MI 49507 MaxLabs, 9189-A Winkler Dr., Houston, TX 77017 MaxOut BODY, 2717 W. Cypress Creek Road, Ft. Lauderdale, FL 33309 Metabolife International, 5643 Copley Drive, San Diego, CA 92111 Metabolite Rx Nature's Nutrition, Inc., 901 Wildwood Trail, Big Sandy, TX 75755 Nutraceutical Cor, 400 Kearns Blvd, Park City, UT 84060 Nutramerica, 8 Ridgedale Ave, Cedar Knolls, NJ 07927 Nutrex Research, Inc., 11007 Creighton Drive, Orlando, FL 32817 NVE Pharmaceuticals, 33 Newton-Sparta Road, Newton, NJ 07860 Optimum Nutrition Inc., 12424 NW 39th St, Coral Springs, FL 33065 Peak Nutrition, Inc., 1097 11th St., P.O. Box 87, Syracuse, NE 68446 Performance Biomedical Laboratories, 1805 Eastern Ave, Baltimore, MD 21231 Pure Performance Nutrition, Inc, 4811 East La Palma Ave, Anaheim, CA 92807 Rexall Sundown/Worldwide Sport Nutrition, 6111 Broken Sound Pkwy, NW, Boca Raton, FL 33487 S.A.N. Corp, 716 N. Ventura Rd., #431, Oxnard, CA 93030 Schwartz Laboratories, 6905 Plainfield Rd, Cincinnati, OH 45236 Scientific Fitness, 140 Pennsylvania Ave, Oakmont, PA 15139 Scitrex, 1187 Coast Village Rd., PMB 478, Santa Barbara, CA 93108 Silver Sage. 5742 W. Harold Gatty Drive, Salt Lake City, UT 84116 SlimSense, 9053 Harlan St., Suite 30, Westminster, CO 80031 Southern Pharmaceuticals, 2190 NW 89th Place, Miami, FL 33172 Sports Nutrition 2000, 113 Knollwood Dr., Suite 425, Cherry Hill, NJ 08002 Sports Nutrition International, 78 Iowa St., Paterson, NJ 07505 Sports One, 47 Capital Drive, Wallingford, CT 06492 Supplement Research & Advancements (SRA), 1930 Village Center Circle, #3-405, Las Vegas, NV 89134 TSN Labs, 6146 South 350 West Suite A1, Murray, UT 84107 TwinLab, 150 Motor Parkway, Hauppage, NY 11788 Ultimate Nutrition, 21 Hyde Rd, Farmington, CT 06034-0643 Universal Nutrition, 3 Terminal Road, New Brunswick, NJ 08901 Urban Biologics, 494 Riverview Drive, Totowa, NJ 07512 VitaLIFE, 1 Scarborough Station Plaza, Scarborough, NY 10510-0806 VPX/Vital Pharmaceuticals, 6573 Stirling Road, Ft. Lauderdale, FL 33314 Wellness International Network, 5800 Democracy Drive, Plano, TX 75024 Here is the bill that passed in California on September 11, 2003, prohibiting the sale of ephedra in the state starting January 1st, 2004. California Senate Bill No.582 - (Ephedrine Group Alkaloids) An act to add Article 4.5 (commencing with Section 110423.100) to Chapter 4 of Part 5 of Division 104 of the Health and Safety Code, relating to public health. The Sherman Food, Drug, and Cosmetic Law contains various provisions regarding the packaging, labeling, and advertising of food, drugs, and cosmetics. Violation of any of these provisions is a crime. The act prohibits the sale of dietary supplements containing ephedrine group alkaloids or steroid hormone precursors unless the product label of these products includes specified information. Existing law makes it a misdemeanor for any manufacturer, wholesaler, retailer, or other person to sell, transfer, or otherwise furnish a dietary supplement containing ephedrine group alkaloids or steroid hormone precursors to a person under 18 years of age. This bill would prohibit the sale or distribution of any dietary supplement product containing ephedrine group alkaloids, notwithstanding the provisions of existing law described above relating to the sale and distribution of these supplements. Because the bill would create a new crime, it would impose a state-mandated local program. This bill would provide that its provisions do not apply in specified circumstances. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. TEXT: THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Article 4.5 (commencing with Section 110423.100) is added to Chapter 4 of Part 5 of Division 104 of the Health and Safety Code, to read: Article 4.5. Ephedrine Group Alkaloids 110423.100. Notwithstanding Article 4 (commencing with Section 110423), the sale or distribution of any dietary supplement products containing ephedrine group alkaloids is prohibited. 110423.101. This article shall not apply, but Article 4 (commencing with Section 110423) shall apply, to any of the following: (a) A California licensed health care practitioner who is practicing within his or her scope of practice and who prescribes or dispenses, or both, dietary supplement products containing ephedrine group alkaloids in the course of the treatment of a patient under the direct care of that licensed health care practitioner, except that a licensed health care practitioner shall not prescribe or dispense dietary supplements containing ephedrine group alkaloids for purposes of weight loss, body building, or athletic performance enhancement. (b) Dietary supplement products containing ephedrine group alkaloids that are sold or distributed directly to a licensed health care practitioner when the dietary supplement product containing ephedrine group alkaloids is used solely for the purpose of the treatment of patients under the direct care of the health care practitioner. (c) Dietary supplement products containing ephedrine group alkaloids that are sold or distributed directly to a licensed pharmacist for resale to a patient for whom the products have been prescribed pursuant to subdivision (a). (d) Dietary supplement products containing ephedrine group alkaloids that are not for resale in California and that are sold or distributed directly to businesses not located in California. SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. 2003 CA S.B. 582 (SN) Here is the bill that passed in New York on August 19, 2003, which became active at the end of October 2003. AN ACT to amend the general business law, in relation to banning the sale of dietary supplements containing ephedra to persons in New York state TEXT: THE PEOPLE OF THE STATE OF NEW YORK , REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS: Section 1. The general business law is amended by adding a new section 391- o to read as follows: Section 391-O. SALE OR PROMOTIONAL DISTRIBUTION OF DIETARY SUPPLEMENTS CONTAINING EPHEDRA. 1. NO PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY COMPANY, OR OTHER ENTITY SHALL SELL OR OFFER TO SELL OR GIVE AWAY, AS EITHER A RETAIL OR WHOLESALE PROMOTION, A DIETARY SUPPLEMENT CONTAINING ANY QUANTITY OF EPHEDRINE ALKALOIDS WITHIN NEW YORK STATE, EXCEPT AS AUTHORIZED BY SUBDIVISION THREE OF THIS SECTION. 2. FOR PURPOSES OF THIS SECTION, THE FOLLOWING TERMS HAVE THE FOLLOWING MEANINGS: (A) "DIETARY SUPPLEMENT" MEANS (1) A PRODUCT (OTHER THAN TOBACCO) THAT IS INTENDED TO SUPPLEMENT THE DIET AND THAT BEARS OR CONTAINS ONE OR MORE OF THE FOLLOWING DIETARY INGREDIENTS: A VITAMIN, A MINERAL, AN HERB OR OTHER BOTANICAL, AN AMINO ACID, A DIETARY SUBSTANCE FOR THE USE BY A PERSON TO SUPPLEMENT THE DIET BY INCREASING THE TOTAL DAILY INTAKE, OR A CONCENTRATE, METABOLITE, CONSTITUENT, EXTRACT, OR COMBINATIONS OF THESE INGREDIENTS; (2) INTENDED FOR INGESTION IN PILL, CAPSULE, TABLET, OR LIQUID FORM; AND (3) LABELED AS A "DIETARY SUPPLEMENT" PURSUANT TO THE FEDERAL DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT, 21 U.S.C. 321, AS AMENDED. (B) "EPHEDRA" MEANS ANY NATURAL OR SYNTHETIC FORM OF EPHEDRINE AND EPHEDRINE ALKALOIDS. 3. (A) NOTHING IN THIS SECTION SHALL APPLY TO NONPRESCRIPTION OVER-THE- COUNTER DRUGS APPROVED OR REGULATED BY THE FOOD AND DRUG ADMINISTRATION. (B) THIS SECTION SHALL NOT APPLY TO MA HUANG (EPHEDRA SINICA) SOLD OR DISPENSED BY ANY PRACTITIONER OF ACUPUNCTURE OR ORIENTAL MEDICINE, WHOSE QUALIFICATION TO USE MA HUANG AND OTHER HERBS IS EXPLICITLY ESTABLISHED VIA EVIDENCE OF AN ACTIVE CERTIFICATION ISSUED TO SUCH INDIVIDUAL FROM AN ENTITY ACCREDITED BY THE NATIONAL COMMISSION OF CERTIFYING AGENCIES (NCCA), OR ANY PHYSICIAN OR ANY PRACTITIONER OF ACUPUNCTURE LICENSED BY THE STATE OF NEW YORK AS LONG AS IT IS NOT SOLD OR DISPENSED AS A DIETARY SUPPLEMENT FOR WEIGHT LOSS, FOR BODY BUILDING, OR AS AN "ENERGY FOOD". 4. ANY PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY COMPANY, OR OTHER ENTITY THAT VIOLATES THE PROVISIONS OF THIS SECTION BY SELLING, OFFERING TO SELL, OR GIVING AWAY AS EITHER A RETAIL OR WHOLESALE PROMOTION, A DIETARY SUPPLEMENT CONTAINING ANY QUANTITY OF EPHEDRINE ALKALOIDS SHALL BE SUBJECT TO A CIVIL PENALTY OF NOT MORE THAN FIVE HUNDRED DOLLARS PER VIOLATION, RECOVERABLE IN AN ACTION BY ANY ENFORCEMENT AUTHORITY DESIGNATED BY ANY MUNICIPALITY OR POLITICAL SUBDIVISION. 5. IT SHALL BE A DEFENSE THAT ANY PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY COMPANY, OR OTHER ENTITY THAT SOLD, OFFERED FOR SALE , OR GAVE AWAY AS EITHER A RETAIL OR WHOLESALE PROMOTION A DIETARY SUPPLEMENT, DID NOT HAVE KNOWLEDGE THAT THE SUPPLEMENT CONTAINED ANY QUANTITY OF EPHEDRINE ALKALOIDS, IF SUCH KNOWLEDGE WAS NOT REASONABLY DISCOVERABLE. Section 2. This act shall take effect on the sixtieth day after it shall have become a law. 2003 NY A.B. 6921 (SN) Ephedra is one of the top selling supplement products in gyms and health food stores around the country. So what happens now? Will there be a grace period so that the stores and manufactures can sell off their remaining stock with penalty? Will the ephedra police come to your door and arrest you, or get a search warrant to come into your house. I can't wait to see the first ephedra arrest because they have some product. Or is it ok to posess it as long as you don't sell it. So many questions? So little answers?