Provexis wins unique EFSA health claim, but will the consumer understand it?

The UK company Provexis and its rich tomato extract Fruitflow® have won a positive health claim decision from EFSA. The applied for claim was quite consumer friendly i.e. “Helps to maintain a healthy blood flow and benefits circulation”. However, the approved claim is very non-consumer friendly, “helps maintain normal platelet aggregation”. With a claim 99% of consumers would not understand is the decision by EFSA so positive after all? Lets take a closer look at the application and the outcome! The ingredient mix in Fruitflow® contains 37 constituent parts and comes in two...
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FDA shoot down Cheerios cholesterol health claim

On the 5th of May 2009 the FDA posted its warning letter to chairman of General Mills stating they had violated the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). In essence the FDA was classifying their claims for the Toasted Whole Grain Oat Cereal ‘Cheerios’ as a drug claim. Based on claims made on their product’s label, the FDA determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention,...
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FDA Seized $1.3 Million Worth of Illegal and Contaminated Sports Supplements

FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements. At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed...
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Is Glucosamine safe - FSA speaks!

The Committee on Toxicity (COT) has today published its view on whether glucosamine, a popular food supplement, can be linked to hepatitis. This follows a small number of case reports, including one that became the subject of a Scottish Fatal Accident Inquiry (though it was later concluded that there was no link), the COT was asked to consider whether a causal association was plausible. The COT concludes that the available data on glucosamine does not indicate any adverse effects of glucosamine on the liver. Glucosamine occurs naturally within the human body and no plausible mechanism by which...
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Muscletech’s Hydroxycut removed from market after reports of consumer death

The first of May see’s the FDA releases a public warning after 23 reports of serious health problems following the use of Hydroxycut containing products. Some within the industry are calling this the next ephedrine fiasco with suggestions of a huge fall out across the weight loss industry damaging an already damaged consumer confidence in such products. Iovate Health Science has agreed to withdraw 14 associated products from the market according to the FDA press release. The 23 reports received by the FDA range from elevated liver enzymes to liver failure and one report of death of a 19 year...
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Health claim community list will not be released in 2010

The European Commission is responsible for co-ordinating the authorization of the list of Article 13 health claims. In response to a question from Mike Penning, the Public Health Minister, Dawn Primarolo, has confirmed that the Commission has acknowledged that the Community List of authorized claims will not be published by 31 January 2010 (the original deadline) because the assessment exercise by the European Food Safety Authority may extend beyond this deadline. In that case, the Minister said that “continued use of these claims would need to be permitted until the final list is adopted. The...
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