HEALTH

Fucopure’s advertising claims forwarded to FTC

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising published by Nutraceuticals International for Fucopure to the Federal Trade Commission for further review.

Nutraceuticals declined to participate in an NAD proceeding, following a challenge to its advertising by P.L. Thomas, a competing maker of dietary supplements.

NAD, the advertising industry’s self-regulatory forum, asked the advertiser to provide substantiation for disease claims that tout FucoPure as a “totally new, totally innovative approach to combating obesity, hyperlipidemia and Type II diabetes.”

Under Food and Drug Administration regulations, no dietary supplement can be purported to treat, mitigate or prevent a disease, which would include obesity, hyperlipidemia and diabetes.

NAD also requested substantiation for weight-loss claims that state FucoPure was proven in the “First U.S. human clinical trial to show the ability of a physician strength Fucoxanthin extract to significantly reduce body weight, percent body fat …” and strong superiority and exclusivity claims, including claims that state that FucoPure is “The Only Clinical Strength Fucoxanthin 10% Extract.”

The advertiser failed to respond to NAD’s initial inquiry, but responded through its attorney after receiving NAD’s second letter. At that time, the advertiser, through its attorney, requested an extension as a professional courtesy, which was granted. The advertiser failed to file a response on the agreed upon date, and despite continued outreach from NAD, has refused to participate.

Given the advertiser’s failure to provide a substantive response, pursuant to Section 2.9 of the NAD/NARB Procedures, NAD will refer this matter to the FTC and FDA for possible law enforcement action.

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Study finds specific probiotic strain safe for human consumption

BY Michael Johnsen

CLEVELAND The results of a safety study to be published in the May issue of Food and Chemical Toxicology demonstrated that the probiotic strain bacillus coagulans GBI-30, 6086 is safe for human consumption, even in massive amounts.

Many experts recognize the health benefits of probiotics, but some have stressed that probiotic strains must first demonstrate safety before recommendations can be made about their widespread use.

“Some probiotics manufacturers want things both ways, suggesting, for example, that clinical studies done on their particular strains apply only to their probiotics, but then staking claim to safety studies conducted on different strains,” stated Andrew Lefkowitz, president and CEO of Ganeden Biotech, which sponsored the study. “It is our belief that both the benefits and the safety of probiotics are specific to individual strains and should be demonstrated by studies.”

Probiotics, also referred to as friendly bacteria, are becoming increasingly popular with consumers for several health benefits. However, safety studies do not exist for many strains of probiotics. Most food manufacturers require some evidence of safety for any ingredient they put into their products, but few probiotic manufacturers are able to cite safety testing on their particular probiotic strains and instead refer to the safe history of use of probiotic strains in general.

“While Bacillus coagulans has always intrigued me as a probiotic strain due to its ability to survive commercial conditions and gastric acidity, I didn’t know much about its safety and efficacy because there was little published data to review,” stated Gary Huffnagle, author of The Probiotics Revolution. “Now that the studies are being published, it will be much easier to recommend it to consumers and to food manufacturers looking to enhance their foods with probiotics.”

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Study reveals babies born to smokers have increased risk of SIDS

BY Michael Johnsen

VICTORIA, Australia Monash University researchers have found that babies born to a mother who smokes are more likely to be slower to wake or respond to stimulation – and this may explain their increased risk of Sudden Infant Death Syndrome, researchers reported last week.

Scientific director of the Ritchie Centre for Baby Health Research Rosemary Horne and researcher Heidi Richardson compared babies of mothers who smoked both during the pregnancy and after the baby was born, with babies who lived in a smoke-free environment.

Horne said the study suggested that maternal smoking can impair a baby’s ability to respond to external stimuli, which may explain their increased risk of SIDS.

“Those babies whose mothers smoked did not have as many arousals overall and the progression of the arousal response through the brain was also impaired,” Horne said. “Mothers who smoked while pregnant and continued to smoke afterward significantly increased their baby’s chances of succumbing to SIDS.”

The study involved 12 healthy, full-term infants born to mothers who smoked an average of 15 cigarettes per day. Their arousal responses during daytime sleep were monitored and compared with that of healthy infants who were born to non-smoking mothers.

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