Part 6: Legal & Regulatory (April 2005)

[4/28/2005] The Ephedra Decision: What Next?
The National Nutritional Foods Association (NNFA) has issued a 'What to Know' clarification and guidance document regarding the court decision against FDA regarding low-dose ephedra supplements. Yesterday, too, the American Herbal Products Association (AHPA) issued a release advising against the sale of all ephedra dietary supplements.
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[4/27/2005] Fiji: Controls Set for Kava Sale
According to an article in the Fiji Times, if and when a Cabinet approved Bill is passed in parliament, Kava Council Chairman Ratu Josateki Nawalowalo will essentially have control over the kava industry, with the bill drafted to encompass uniformity in processing, packaging and caring for the plants before they were used locally or exported overseas. According to the article, Ratu Josateki said that poor quality and packaging contributed to the kava ban from European countries last year, and under the new program, licenses will be issued and the council would set requirements that must be met before product could be sold.
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[4/25/2005] Star Democrat Editorial: Empower the FDA
An editorial this past weekend in The Star Democrat suggests that FDA needs to be more empowered, citing the Anabolic Steroid Act of 2004 and its omission of dehydroepiandrosterone (DHEA) and the recent Utah court ruling against the FDA and for Nutraceutical international Corp. for dietary supplements containing low doses of ephedra. The tone of this editorial has been echoed in other recent coverage, including a Salt Lake Tribune article link provided which talks about the ephedra situation.
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[4/22/2005] Splenda to Face California Courts on 'False Advertising' Claims
According into a release issued by the U.S. Sugar Association, a federal court in California has ruled (April 15) that McNeil Nutritionals and parent company Johnson & Johnson, the makers of the artificial chemical sweetener Splenda, are to face allegations that their marketing and advertising program for the product is false and misleading. According to the release, the Sugar Association can represent its members on this issue.
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[4/22/2005] FDA Issues New Guidance on Dietary Supplement Labeling
The US FDA's Office of Nutritional Products, Labeling, and Dietary Supplements has posted 'A Dietary Supplement Labeling Guide' on its website, a document organized into 8 chapters and six appendices covering labeling, claims, new dietary ingredients and more in a question/answer format.
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[4/19/2005] South African Activist Group Threatens Legal Action Against Medicines Control Council
According to an article on South Africa's, an organization entitled Treatment Action Campaign (TAC) has threatened legal action against South Africa's Medicines Control Council (MCC) if that body does not shut down what it alleges are certain 'unauthorized, unethical and dangerous' medical activities of Matthias Rath in that country. According to the article, (and statement issued by TAC) the complaint stems from experiments presently being conducted on people with HIV who are being provided with multivitamins. According to a Reuters article on Yahoo, this move is the latest in a series of altercations, as Rath has aggressively advertised the use of his vitamins to counter AIDS, rather than anti-retroviral drugs. Rath has also accused TAC of being a front for pharmaceutical companies.
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[4/18/2005] High-Dose Ephedra Pills Still Illegal, FDA Says
According to a Reuters article on Yahoo News, the Food and Drug Administration has stated that the ban on sales of ephedra products remains in place for higher doses , despite last week's Utah ruling in favor of Nutraceutical International Corporation which stated that FDA had failed to show low ephedra doses posed a "significant or unreasonable risk." According to an article on Medpage Today, in light of the judgment, FDA is evaluating all its options including a possible appeal.
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[4/15/2005] Court Rules in Favor of Nutraceutical Regarding Low Dose Ephedra Products
A Federal Court in Utah has ruled in favor of Nutraceutical International Corporation against the FDA, noting that no evidence of low-dose risk (10mg per day or less of ephedrine alkaloids) had been presented by FDA, and that DSHEA contains no provisions for risk-benefit analysis.
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[4/11/2005] Amid Drug Scandals, Athletes Strike at Supplement Companies
According to a Boston Globe article, at least five athletes have initiated lawsuits against nutritional supplement companies, alleging that the products these companies produce are the cause of failed tests for banned supplements. According to the article, the scope of products range from vitamins to whey protein powder, and one supplement company, MuscleTech Research and Development Inc., has filed countersuits against two athletes.
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[4/5/2005] EU Courts Set to Reject Ban On Food Supplements
According to a Dow Jones article on Borsa Italiana, in a preliminary ruling, the European Court of Justice has rejected a European Union ban on a broad range of food supplements that is set to take effect in August. The issue had been brought to the court by industry representatives from the UK, challenging that the EU ruling would deprive consumers of numerous proven products, and provide companies with limited means to get product approvals after the legislation took effect. According to the article, the court's advocate general agreed, noting that "the ban (part of the Food Supplements Directive) violates basic legal principles, including proportionality, legal protection, legal certainty and sound administration." According to BBC News coverage, the Advocate General Leendert Geelhoed noted that he was not opposed to the legislation in principle. The court must still make a final decision on the rules.
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[4/1/2005] Enzyte Creator's Accounts Frozen
According to an article in the Cincinnati Enquirer, federal authorities have frozen the personal accounts of Steven Warshak, owner of Berkeley Premium Nutraceuticals, as well as other family accounts, alleging that the money was obtained by fraud. According to the article, 14 accounts were seized or frozen the same day that federal agents raided three company locations two weeks ago, and under this set of circumstances, a spokesperson for the U.S. Attorney's office, which filed the complaint, notes that the burden of proof rests with the defendant to prove that the assets are not connected to criminal activity.
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