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Part 6: Legal & Regulatory (June 2005)

Companies in the News: InterHealth Nutraceuticals Inc., Chrysantis(TM), Inc., Nutrition 21, Inc., Lonza Group, Nutraceutical Corporation, Berkeley Premium Nutraceuticals, Lifekey Inc., Warner Health Care, Boland Naturals, Wagner Nutraceuticals, Gero Vita International, Tropicana Products, Inc., Sabinsa Corporation.

[6/30/2005] ChromeMate(R) Affirmed GRAS (Generally Recognized as Safe)
US-based ingredient company InterHealth Nutraceuticals Inc. has announced the completion of its GRAS (Generally Recognized as Safe) affirmation process for ChromeMate(R), the company's patented form of biologically active, niacin-bound chromium.
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[6/29/2005] Chrysantis(TM) NDI Application Gets Green Light
US-based Chrysantis(TM), Inc. has announced that FDA has not objected to the company's New Dietary Ingredient (NDI) submission, therefore allowing Chrysantis' zeaxanthin to be legally sold as a dietary supplement in the United States.
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[6/22/2005] FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition
US-based ingredient company Nutrition 21, Inc. (NXXI) has announced that the U.S. Food and Drug Administration (FDA) has requested a 60-day extension to review the qualified health claim petition the company has submitted asking to associate chromium picolinate with a reduced risk of insulin resistance, type 2 diabetes and related disease.
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[6/21/2005] FTC Settles Claims with Marketers of Fiberthin and Propolene
The U.S. Federal Trade Commission (FTC) has announced that the marketers of the dietary supplements FiberThin and Propolene have settled FTC charges that their misleading weight-loss claims violated federal laws. The defendants are barred from making false claims about any dietary product in the future and are required to pay $1.5 million in consumer redress.
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[6/21/2005] Lonza and Nutraceutical Agree to Settlement of Litigation
Lonza Ltd., a subsidiary of the Switzerland-based Lonza Group has announced that the company and US-based supplement company Nutraceutical Corporation, have settled pending litigation involving Lonza's U.S. Patent No. 5,073,376 involving L-carnitine. According to the release, As part of the settlement, Nutraceutical and Lonza each agreed to dismiss their claims against each other, with Nutraceutical agreeing to purchase all of its requirements for L-Carnitine L-Tartrate in the United States from Lonza Inc.
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[6/20/2005] India: Health Supplement Draft to be Part of Food Safety and Standards Bill
According to an article on, India is set to make the Health Supplement Bill proposed by the Union Ministry of Health into part of an integrated food law, Food Safety and Standards Bill, 2005. According to the article, this is the latest move in a tug of war over whether health supplements would be under the purview of drug control officials or moved to the jurisdiction of food authorities.
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[6/16/2005] Six States File Suits Against Berkeley
According to an article in the Cincinnati Enquirer, attorneys general in Arkansas, Illinois, North Carolina, Ohio, Oregon and Texas have all filed civil suit against supplement company Berkeley Premium Nutraceuticals and owner Steve Warshak accusing the company of deception in the sale of unproven sexual aids and other nutritional supplements. The Ohio lawsuit, according to the article, also names four Berkeley sister companies: Lifekey Inc., Warner Health Care, Boland Naturals and Wagner Nutraceuticals and cites 15 products.
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[6/15/2005] Government to Fight Ephedra Ruling
According to an article on, the U.S. Department of Justice has filed a notice of appeal asking the U.S. court of Appeals to reconsider its April ruling in favor of Nutraceutical Corp. that the Food and Drug Administration failed to prove that ephedra is unsafe at low doses.
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[6/14/2005] UAE- Herbal Medicines to Join List of Approved Medicines
According to an article in the Khaleej Times, the General Authority of Health Services for the Emirate of Abu Dhabi (UAE) is planning to incorporate a list of herbal and traditional medicines into the list of approved medicines while also finalizing a draft for Good Manufacturing Practices.
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[6/14/2005] India: Kerala To Allow Nutraceuticals Sales at Reduced VAT
According to an article on, the state of Kerala has become the first in India to allow the sale of dietary supplements through retail 'chemists' at a 4% Value Added Tax (VAT), the same rate as prescription drugs rather than the 12% rate which would otherwise apply.
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[6/9/2005] Supplement Marketers Settle FTC Charges
US-based supplement company Gero Vita International and six related defendants have settled Federal Trade Commission (FTC)charges that they violated federal law by claiming that their products could cure or treat numerous illnesses and conditions, including asthma, diabetes, Alzheimer’s disease, overweight, and sexual dysfunction. The defendants are barred from making misleading claims about their products and are required to pay judgments totaling $605,000.
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[6/7/2005] Lycopene Extract Draft Opinion Announced
The Food Standards Agency (UK) has announced that it is calling for views on the agency's draft opinion on allowing lycopene-rich tomato extract to be used as a novel food. The applicant, LycoRed, proposes to market its lycopene oleoresin for use as a novel food ingredient in a range of food products, including yoghurts, cheese, bread, sausages and cereal bars, at a level of 5 mg of lycopene per serving.
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[6/6/2005] Oregon House Downs Athlete Dietary Supplement Bill
According to an AP article, the Oregon House has rejected a bill to bar coaches from encouraging students to use performance-enhancing nutritional supplements, claiming the bill was misguided and overly broad. According to the article, the Bill, which had passed the Senate, was defeated 30-27, as opponents noted that it is already illegal to use unprescribed steroids, while the current bill is targeted at legal supplements such as creatine.
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[6/3/2005] FTC Puts the Squeeze on Tropicana’s Orange Juice Claims
The U.S. Federal Trade Commission has settled a complaint against Tropicana Products, Inc., in which it alleged the company misled consumers with claims that drinking two to three glasses a day of its “Healthy Heart” orange juice would produce dramatic effects on blood pressure, cholesterol, and homocysteine levels, thereby reducing the risk of heart disease and stroke.
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[6/1/2005] Sabinsa's ForsLean Brand Coleus Forskohlii Extract Not Connected With Product Contamination in Italy
Ingredient company Sabinsa Corporation has responded to notices issued by the Italian Regulatory Authority and the Medicines and Healthcare Products Regulatory Agency in the United Kingdom regarding adverse drug reaction reports associated with the use of Coleus forskohlii containing products in Italy. The company states that its ForsLean® brand Coleus forskohlii extract is not linked in any way to the contaminated Coleus forskohlii products discovered in Italy.
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