Part 6: Legal & Regulatory (July/August 2005)

Companies in the News: Cereal Partners UK, Nutrition 21, LycoRed Natural Products Industries, Goen Technologies, Merck Eprova AG, Fuji Health Science, Inc, DSM Nutritional Products, Ultimate Nutrition, Nutraquest Inc., Cytodyne Technologies, Cargill Health & Food Technologies, Natural Alternatives International, Inc., Lane Labs.

[8/31/2005] UK: Shreddies Ad Misleads
According to an article on, the UK's Advertising Standards Authority has declared that a TV commercial for Shreddies breakfast cereal, presented by Cereal Partners UK, has misled consumers by exaggerating the relevance of studies which claimed the product boosted children's mental energy, therefore breaching that county's advertising code.
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[8/30/2005] South Africa: ASA Cracks Down on Rath
According to an article on South Africa's, that country's Advertising Standards Authority (ASA) has declared that all of supplement provider Dr Matthias Rath's advertising must be first cleared with and approved by the authority. According to the article, the Rath Foundation said it would ignore the ruling.
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[8/29/2005] FDA Approves First Qualified Health Claim for Chromium Picolinate and Risk of Type 2 Diabetes
The US Food and Drug Administration (FDA) has issued a favorable response to a qualified health claim petition filed by US-based supplement company Nutrition 21, recognizing chromium picolinate as a safe nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes. The health claim allowed by the FDA reads, "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain." Other qualified claims proposed by the company were not permitted.
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[8/29/2005] Former Georgia Man Under Investigation for Herbal Paste Promoted as Cancer Cure
According to an Associated Press article, a Georgia man has been accused by that state's Medical Board of practicing medicine without a license and FDA agents have raided his business, as he claims that his bloodroot paste triggers apoptosis and thus is effective against skin cancers. So far no criminal charges have been filed in the case.
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[8/26/2005] CRN Comments on California Bill SB 37
The Council for Responsible Nutrition is actively fighting California bill SB 37, a bill intended to protect high school athletes, (and essentially a reintroduction of a Bill vetoed last year by Governor Schwarzenegger), on the grounds that the current bill does not include performance enhancing substances such as steroids, growth hormones and illegal drugs, and instead calls for a banned supplements list, rather than a banned substances list. The communication materials issued by CRN ask for opposition to the Bill or amending the wording to state all performance-enhancing substances rather than 'dietary supplements' to make the bill more meaningful and effective.
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[8/26/2005] India Asks EU to Exempt Ayurvedic Drugs From Curbs
According to an article on India's, that country's commerce and industry minister has sent a communication to EU Trade commissioner Peter Mandelson, requesting that the EU exclude ayurvedic products from the proposed directive on traditional herbal medicinal products (THMPD), which when implemented in October, would only allow acceptance of products that had been used in Europe for at least 15 years.
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[8/25/2005] USDA Relents on Scope of National Organic Program
The U.S. Department of Agriculture's Agricultural Marketing Service (AMS) has issued a memorandum informing organic certifiers that “[t]here are agricultural products, including personal care products, that, by virtue of their organic agricultural product content, may meet the NOP standards and be labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ pursuant to the NOP regulations,” and that “products that may be labeled ‘100 percent organic’ or ‘organic’ may also carry the USDA organic seal” .
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[8/22/2005] India: New Cosmetics Rules Contemplated
According to an article in India's Financial Express, that country's government is suggesting more stringent regulations for cosmetics including registration of imported cosmetics and making it mandatory for cosmetics sold in the country to have all ingredients listed in descending order of contribution to the formulation.
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[8/18/2005] UK: Warning on Imported Herbal Remedies
According to an article in the UK's Daily Mail, that country's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning that unlicensed herbal medicines containing heavy metals, specifically mercury, arsenic and lead, may be available in the UK.
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[8/18/2005] FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition
US-based supplement company Nutrition 21, Inc. (NXXI) has announced that it has agreed to the US Food and Drug Administration (FDA) request for a two week extension for its evaluation of the company's qualified health claim petition for chromium picolinate.
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[8/17/2005] Food & Drug Administration Approves LycoMato® as Safe Color Additive
Israel-based LycoRed Natural Products Industries has announced that the Food and Drug Administration (FDA) is amending its color additive regulations, adding LycoMato® to the FDA’s listing of Color Additives Exempt from Certification.
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[8/17/2005] State Settles Claim Against Dietary Supplement Distributor
According to an article on, weight-loss products distributor Goen Technologies has agreed to revise its marketing practices and to pay restitution to customers who filed complaints with the Division of Consumer Affairs, as well as to pay $750,000 to the state of New Jersey.
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[8/10/2005] Ghana: Food & Drugs Board Warns of Dangers of Herbal Medicine
According to an Accra article on, Ghana's Chief Executive Officer of the Food and Drugs Board (FDB), Emmanuel Agyarko has announced that the Board is taking steps to curtail misleading advertising associated with herbal medicines and urging consumers in that country to not buy products that have not been certified by the Food and Drugs Board.
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[8/9/2005] LycoRed Affirms GRAS for Lyc-O-Mato® Powder
LycoRed Natural Products Industries, Ltd. has received word that FDA is satisfied with LycoRed’s determination that Lyc-O-Mato® Powder is safe for functional food use, paving the way for applications and categories such as breads, cereals, beverages and meat analogues.
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[8/9/2005] Metafolin ruled safe for use in supplements and foods by JECFA
Merck Eprova AG is a wholly-owned subsidiary of Germany-based Merck KGaA has announced that Metafolin, its new patented form of folate, has been approved as a safe alternative to folic acid for use in dietary supplements, foods for special dietary uses and other foods by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
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[8/8/2005] Natural Health Products Directorate Posts List of Approved Products
Canada's Natural Health Products Directorate, responding to industry requests, has posted a list of approved natural health products (NHPs) online. According to the Directorate, this list is now available and will be updated on a monthly basis until a more complete searchable database is available.
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[8/8/2005] FWS Extends Harvest Age on Wild American Ginseng to 10 Years
The U.S. Fish and Wildlife Service (FWS) has announced that it has determined that the minimum age for legal export will be extended from 5 years to 10 years, and require that exportable plants be limited to those that bear not less than four leaves, rather than the current minimum of three.
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[8/4/2005] CRN Supports 'Food Stamp' Bill
US-based trade association The Council for Responsible Nutrition has sent a letter of support to the Senate Agriculture, Nutrition and Forestry Committee urging the members to give strong consideration to The “Food Stamp Vitamin and Mineral Improvement Act of 2005,” introduced last week by Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah), which would provide low-income households the opportunity to use food stamps to purchase vitamin and mineral supplements.
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[8/3/2005] FSANZ seeks Public Comment on Proposed Changes to the Food Code
Food Standards Australia New Zealand (FSANZ) is seeking comment on several proposals including Phytosterols in fruit juice and fruit juice drinks, and fortification of cereal-based beverages.
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[8/2/2005] Nutrition 21 Receives Widespread Approval in Europe for the Continued Sale of Chromax(R) Chromium Picolinate and Zinmax(R) Zinc Picolinate
US-based supplement company Nutrition 21, Inc., (NXXI) has announced that it has received "derogation" (approval for continued sale) in more than 17 member states within the European Union (EU) for Chromax(R) chromium picolinate and Zinmax(R) zinc picolinate as ingredients and stand-alone brands.
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[8/1/2005] Ontario to standardize Chinese Medicine, Acupuncture by Year End
According to an article on, the Province of Ontario is planning to regulate traditional Chinese medicine and acupuncture by the end of the year, following a series of ten recommendations issued by a government-appointed panel. According to the article, the requirements will include setting up a regulatory college and designating practitioners who use Chinese herbal medicines as herbalists, with national and provincial Chinese medicine associations supporting the new regulations.
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[7/29/2005] AHPA Posts Revised Facts about Codex / EU Directive / CAFTA
The American Herbal Products Association (AHPA) has revised its document “Codex Alimentarius and dietary supplements,” to provide information on the current status of the European Union’s Directive on Vitamin and Mineral Supplements and to address emerging concerns related to CAFTA.
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[7/26/2005] Fuji Health Science Successfully Completes NDI Notification, Allowing Capacity Increase
Fuji Health Science, Inc., an American subsidiary of Japan-based Fuji Chemical Industry Co., Ltd. has announced the successful completion of a New Dietary Ingredient (NDI) notification to the FDA for its AstaREAL® astaxanthin, produced at the company's facility in Gustavsberg, Sweden. Previously, the company had been marketing the product under an NDI for material produced in Hawaii.
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[7/25/2005] DSM TEAVIGO(TM) Pure and Natural Green Tea Extract Now Self-Affirmed GRAS
Netherlands-based ingredient company DSM Nutritional Products has announced that the company's natural green tea extract, TEAVIGO(TM), has been self-affirmed GRAS (Generally Recognized As Safe).
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[7/20/2005] Court Vacates Judgment Against Ultimate Nutrition In The Matter of Kicker Vencill vs. Ultimate Nutrition
Superior Court of the State of California in Orange County granted the request of Ultimate Nutrition to vacate the judgment against the company, according to Todd Croutch, attorney with Fonda & Fraser in Los Angeles.
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[7/19/2005] Senate Confirms Crawford as FDA Commissioner
US Senate confirmed Lester Crawford, DVM, PhD, as FDA Commissioner by a vote of 78 to 16. Dr. Crawford had served as Acting Commissioner for all but 16 months since the Bush administration first appointed him to that role in February 2002
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[7/15/2005] Health Canada Warns Consumers Not to Use Some Ayurvedic Medicinal Products
Health Canada has issued a consumer warning that some ayurvedic medicinal products contain high levels of heavy metals such as lead, mercury and or arsenic and that it will remove the products from the market and prevent further importation.
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[7/14/2005] New Bill Targets Herbal Supplements
According to a release issued by the American Herbal Products Association (AHPA), a new bill, The Dietary Supplement Access and Awareness Act (HR 3156) has been introduced by US Representative Susan Davis (D-CA) and co-sponsored by Henry Waxman (D-CA) and John Dingell (D-MI), and proposes to establish legislative authority for the use of risk-benefit analysis in evaluating an ingredient’s unreasonable risk. According to the release, the Bill is the same as one introduced in the last Congress, with the addition of the clause noting that “presence of even a relatively small risk of a serious adverse health effect” would be considered unreasonable in the absence of a “sufficient benefit".
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[7/13/2005] Five Hundred Dossiers Submitted to Agency on Safety of Food Supplements
The UK Food Standards Agency has reported that it has received 500 dossiers from the supplements industry providing information on vitamins and minerals to enable the European Food Safety Authority (EFSA) to make safety assessments.
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[7/12/2005] Cos. to pay nearly $1M in Ephedra case
According to an AP article in the Seattle Post, Nutraquest Inc., the successor to Cytodyne Technologies, and three related companies have settled with the state of New Jersey for nearly $1 million over allegations that exaggerated benefits and understated risks were stated about the company's ephedra containing products.
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[7/12/2005] Digestive Health Benefit of Oliggo-Fiber® Inulin Recognized by International Authorities
US-based Cargill Health & Food Technologies has reported that the French food safety authority, AFSSA has recently approved a prebiotic health claim for food products containing native chicory inulin, specifically, Oliggo-fiber® Instant inulin.
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[7/12/2005] Health Food Industry Loses EU Vitamin Case
The European Court of Justice (ECJ) has ruled in favor of the European Commission, upholding the validity of the Food Supplements Directive which is set to ban those ingredients not on an approved list as of August. The victory comes against challenges to the Directive brought forward by consumers and retailer associations in the UK. In upholding the Directive, the court added that a positive list system must be accompanied by a procedure which allows a given substance to be added to the lists, leaving this task to the European Commission. A Dow Jones article notes the surprise decision in light of the previous rejection of the ban in April by Advocate General Leendert Geelhoed who criticized the lack of transparency in the process to add a product to the list. According to an article on, the ruling puts the European health food industry into uncertainty as the directive enters force on August 1 of this year. The article quotes John Bowis MEP, Conservative health spokesman in the European Parliament, as saying the decision was a defeat for common sense and a victory for overregulation.
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[7/11/2005] Canada: NHPD Site License Deadline Approaching
Canada's Natural Health Products Directorate (NHPD) has issued a note reminding stakeholders that the December 31, 2005, deadline is fast approaching and that those individuals who have not yet submitted a site license application should do so as soon as possible. Individuals that do not have a valid site license by the December 31, 2005 deadline, will no longer be authorized to manufacture, import, label, or package natural health products for sale in Canada.
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[7/8/2005] Nutrition 21 Sues GNC for Patent Infringement
US-based Nutrition 21, Inc. (NASDAQ: NXXI) announced that it has filed a patent infringement lawsuit against GNC Corporation, Inc. and its wholly owned subsidiary, General Nutrition Centers, Inc. for infringement of Nutrition 21’s chromium picolinate patents.
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[7/6/2005] Natural Alternatives International, Inc. Awarded TGA Recertification of Good Manufacturing Practices
US-based custom formulator Natural Alternatives International, Inc. (NAI) has announced that the Therapeutic Goods Administration of Australia has completed its audit of the company's Good Manufacturing Practices and recertified the company's U.S.-based manufacturing facilities.
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[7/5/2005] FDA Warns Against Chinese Supplement
According to an AP article in the Daily Democrat, the U.S. Food and Drug Administration has notified consumers of a safety risk associated with the use of a Chinese herbal supplement, sold in herbal product stores and by mail order through Bugle International. According to the article, the product was sold as part of a two-bottle set, one containing 90 capsules labeled Liqiang 4 Dietary Supplement Capsules and the other labeled Liqiang 1, with the Liqiang 4 capsules containing a diabetes drug that could cause life-threatening reactions in some people.
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[7/5/2005] Codex Adopts Proposed Vitamin and Mineral Guidelines
Yesterday, the full Commission of Codex Alimentarius adopted in final form, the Codex Guidelines for Vitamin and Mineral Food Supplements, by consensus method, following limited discussion and comments from a few countries and two NGO's. This adoption means that the Guidelines are no longer in draft form and future steps in the dialogue will be the establishment of permitted levels for vitamins and minerals - based on risk assessment. According to a release issued by Diane Miller, JD of the National Health Freedom Coalition (currently attending the Rome meeting), Attorney Scott Tipps of the National Health Federation (consumer organization with NGO status) requested the guidelines not be adopted but rather be sent back to committee, while NGO IADSA (International Alliance of Dietary/Food Supplement Associations) noted that the draft guidelines should be adopted because they had been worked on in committee for almost 10 years and that valuable consensus had been reached in the Bonn Germany committee meeting last year. The guidelines apply only where these products are regulated as foods.

[7/1/2005] Lane Labs Agrees To Pay $8 Million
According to an article on, US-based supplement company Lane Labs has agreed to pay $8 million as part of a settlement, to customers who purchased the company's BeneFin, MGN-3 and SkinAnswer between September 1999 and July 2004. According to the article, the company is continuing one of its appeals, disputing that violation of the federal Food, Drug, and Cosmetic Act carries a restitution penalty. If the appeal is denied, the company would settle the case for the $8 million.
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[7/1/2005] FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers
The U.S. Food and Drug Agency (FDA) has announced the results of a review of qualified health claims that green tea may reduce the risk of certain types of cancer, and determined that it considers it unlikely that green tea reduces cancer risk. According to the agency, it is currently considering exercising enforcement discretion in the matter.
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