Part 6: Legal & Regulatory (Feb. 2005)

[2/25/2005] AHPA Files Additional Comments with FDA on NDI Process
Trade association The American Herbal Products Association (AHPA) has filed additional comments with the US Food and Drug Administration (FDA) regarding the New Dietary Ingredient notification process. In the most recent comments, AHPA notes its concern over whether each company that sells a dietary supplement containing a New Dietary Ingredient (NDI) must file a separate 75-day pre-market notification.
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[2/25/2005] Supplements Seized from Pennsylvania Fitness Shop
According to an article in the Pittsburgh Post-Gazette, federal marshals have seized approximately $13500 worth of alleged ephedra-containing supplements from ATF Fitness Products Inc. of Oakmont, Pennsylvania, following an inspection and series of lab tests last year.
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UK Court
Rules Kava Will Stay Prohibited
According to an article on The Scotsman, Britain's court of Appeal ruled yesterday that sales and import of kava-kava will remain banned and that the information under which the Department of Health imposed the ban in January 2003, was adequate.
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[2/18/2005] FDA is Satisfied with LycoRed’s GRAS Classification of LycoMato(R)
Israel-based LycoRed Natural Products Industries, Ltd. has announced that the US Food and Drug Administration has responded to their GRAS submission covering LycoMato® oleoresin and the LycoPen® formulations, saying that the agency has no questions at this time.
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[2/16/2005] Solae Company Settles Patent Infringement Suit Against ADM and Amerifit
US-based The Solae Company has announced that it has settled an isoflavone concentrate patent infringement suit it originally filed in 2003 against Archer Daniels Midland Company (NYSE:ADM) and Amerifit Nutrition, Inc. According to the terms of the settlement, ADM has agreed to purchase The Solae Company's global isoflavone concentrate business including The Solae Company's isoflavone concentrate patent portfolio.
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[2/15/2005] Supplement Maker Sued Over Black Cohosh Product
According to an article in the Omaha World-Herald, a woman is suing supplement maker Pharmavite LLC, alleging that the company's black cohosh product, marketed under its Nature's Resource label, failed to warn consumers about possible danger associated with use of the product.
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[2/15/2005] Crawford Nominated to be FDA Head
According to an article on MarketWatch, the Bush administration has indicated that it will nominate Food and Drug Administration (FDA) Acting Commissioner Lester Crawford as Commissioner of the FDA.
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[2/15/2005] PharmaNutrients Submits CLA One® Body Composition Structure-Function Claims Filing to FDA
US-based ingredient company Pharmanutrients, Inc. has announced that it has filed for several body composition structure-function claims with the US Food And Drug Administration (FDA) for its CLA One product.
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[2/14/2005] Support Growing for UK Regulation of Alternative Medicine Practitioners
According to an article on the UK's Government News Network, a report suggests that nine out of ten practitioners, patient groups and consumers support Department of Health proposals set to regulate practitioners of alternative medicine. The standards include a register of practitioners, and the use of a specific title by those registered. The most recent consultation, according to the article, included 30 practitioner groups, as well as patient and consumer organizations.
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[2/9/2005] UNPA Files Comments with FDA Regarding NDIs
The Utah Natural Products Alliance (UNPA) has filed comments with the US Food and Drug administration responding to that agency's request for comments on the premarket notification program for new dietary ingredients. The comments include notes on the term 'chemical composition', the process under which an 'old dietary ingredient' might become a 'new dietary ingredient', and the concept of filing NDI notices for ordinary changes in conditions of use.
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[2/4/2005] New Rules Expected for CaliforniaState Athletics
According to an article on, proposed regulations are expected to be introduced in Oakland today, designed to eliminate the use of steroids and restrict the use of performance-enhancing supplements by student athletes. According to the article, the California Interscholastic Federation is set to propose three policies: requiring all coaches to be certified in an education program including a class on performance-enhancing drugs and supplements, prohibiting steroids except on a doctor's orders, and prohibiting coaches and school workers from selling, distributing and promoting performance-enhancing supplements, and prohibiting athletic programs from accepting sponsorships from manufacturers of these products. The final policy won't come up for a vote until September.
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[2/3/2005] ABC, CRN File Comments to FDA on New Dietary Ingredients
US-based American Botanical Council (ABC) and Council for Responsible Nutrition (CRN) have both filed comments with the US Food and Drug Administration regarding that agency's procedure for pre-market notification for New Dietary Ingredients (NDIs). Among other points, ABC’s comments suggest that FDA should officially recognize the lists developed by AHPA, CRN, and UNPA as positive lists of Old Dietary Ingredients (ODIs), with the organization believing it should not be necessary to create a new 'authoritative' list. CRN's comments include noting the need for additional discussion on NDIs and other topics, argues that the scope of 'old' dietary ingredients must be broad, and notes that while "changes in dosage or intended use or processing do not make an old ingredient “new", ... such changes may well raise safety issues that need to be addressed by manufacturers and potentially by FDA. CRN also has commented that an NDI notification should include information about the intended use of the ingredient, and endorses six of seven recommendations listed in the November meeting notice.
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[2/2/2005] AHPA Comments on FDA’s Pre-market Notification Program for NDIs
US-based trade association, the American Herbal Products Association (AHPA) has filed comments with the Food and Drug Administration regarding New Dietary Ingredient notifications. Input from the association includes suggestions to winnow out dietary ingredients that are not new, including recognizing AHPA’s Herbs of Commerce, 2nd edition as a source document, suggests that a botanical's Latin binomial, author, and part be identified, and opposes FDA’s contention that the “chemical composition” or “active components” needs to be disclosed.
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[2/1/2005] Bill to Regulate Sale, Export of Traditional Medicines in Pakistan Pending
According to an article in Pakistan's Khaleej Times, a bill to regulate sale, storage and export of traditional medicines will be introduced during that country's next session of the National Assembly.
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