HEALTH

Reckitt Benckiser makes $2.3 billion offer for Adams

BY Michael Johnsen

CHESTER, N.J. Reckitt Benckiser Group on Friday commenced its previously announced cash tender offer for all of the outstanding shares of Adams Respiratory Therapeutics in a deal that would be worth $2.3 billion, first announced Dec. 10.

The deal will expire if not approved by Adams’ shareholders by Jan. 23.

The offer is being made through Twickenham, a wholly-owned subsidiary of Reckitt Benckiser. Adams’ board has unanimously determined that the offer is fair to and in the best interests of Adams’ stockholders and recommended that holders of Adams common stock accept the offer and tender their shares in the offer.

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NAD finds in favor of Relaxane’s ad claims

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus has determined that advertising claims for Relaxane, a dietary supplement advertised by Indegene Pharmaceuticals to relieve the symptoms of stress, are supported by the evidence provided by the advertiser.

NAD examined labeling claims and Internet claims that included: 

  • “For the first time—a clinically tested non-addictive product that relieves the symptoms of everyday stress.”
  • “Relaxane is effective in managing everyday stress, it alleviates multiple symptoms of everyday stress—frustration, irritability, restlessness, stress-related gastrointestinal discomforts (fullness, bloating, cramps) and stress-related minor muscle pain.”
  • “Relaxane is designed to provide stress relief and address multiple symptoms of stress.”
  • “Relaxane is an innovative stress reducer, clinically tested, optimized plant-derived Natural molecular composition of valeriana officinalis, melissa officinalis, passiflora incarnata and petasites hybridus that work on the multiple symptoms of stress.”

The advertiser presented as evidence three studies performed on the product.

Following its review of the evidence, NAD was satisfied that the challenged advertising clearly conveys that Relaxane is for, and has been tested for, relief and alleviation of the symptoms associated with stress. NAD determined as well that the advertiser provided a reasonable basis for a claim that Relaxane, when taken as directed, is non-addictive.

Indigene Pharmaceuticals, in its advertiser’s statement, said the company is pleased that NAD has found that claims for Relaxane are substantiated. “In particular,” the company stated, “Indigene Pharmaceuticals, is pleased that NAD has found that clinical testing on a Relaxane product itself is the gold standard for supporting advertising claims.”

NAD, the advertising industry’s self-regulatory forum, has expanded its review of dietary-supplement advertising, pursuant to a series of grants made by the Council for Responsible Nutrition. 

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Senators propose DHEA Abuse Reduction Act of 2007

BY Michael Johnsen

WASHINGTON Sens. Charles Schumer, D-N.Y. and Chuck Grassley, R-Iowa, on Tuesday announced a set of proposals that in part would make it illegal to sell dehydroepiandrosterone, a supplement touted for both its anti-aging and muscle mass boosting claims, without a prescription.

Specifically, the bill, S. 2470, or the Dehydroepiandrosterone Abuse Reduction Act of 2007 proposes to amend the Controlled Substances Act to prevent the access of DHEA to minors and create penalties to those who would provide DHEA to minors.

“DHEA is a precursor steroid hormone to testosterone that is banned by all professional sports leagues, except Major League Baseball,” Grassley told reporters at a press conference Tuesday. “The opponents of my legislation will tell you that DHEA does nothing to kids, but studies reveal this isn’t the case. When taken in high doses over time, DHEA, like its relatives in the steroid family, may cause liver damage and cancer,” he said. “What is even more disturbing is the fact that DHEA is being marketed online to kids. One bodybuilding website, directed towards teenagers, features a teen bodybuilder of the week to promote performance-enhancing drugs. The person you see in this chart is a former Junior National Champion bodybuilder. When asked what supplement gave him the greatest gains for his competition this teenager replied ‘DHEA.’”

 “We strongly oppose the attempt to restrict access to a legal and safe supplement product—DHEA—under the guise of protecting consumers from ‘performance-enhancing drugs,’” countered Steve Mister, president and chief executive officer of the Council of Responsible Nutrition. “There is no evidence that DHEA is being abused by minors nor is there evidence that DHEA works as a performance-enhancing product in young healthy adults,” he said. “This bill would in no way address the problem of illegal anabolic steroid use. In short, this proposed legislation is a solution in search of a problem.”

Many manufacturers of DHEA supplements already recommend on their labels that children under the age of 18 not use the supplements, Mister added.

Unlike anabolic steroids, DHEA is naturally produced and is the most common steroid hormone in the body, CRN noted. The body tightly regulates the conversion of DHEA, preventing excess production of testosterone—essentially the body recognizes when it is already achieving normal hormone levels and thus ‘ignores’ the additional DHEA.

Hundreds of thousands of older adults safely and responsibly use DHEA due to their bodies’ inability to effectively produce healthy hormone levels on their own. According to CRN, DHEA has promising use to help support immune function, maintain cognitive function and elevate mood, improve sleep patterns, maintain strong bones and normalize glucose metabolism.

But Grassley has singled out DHEA before, calling for an out-and-out ban of the supplement, and this latest bill seems to be a compromise. “I have introduced two bills in the past that would make DHEA a controlled substance, but I realize that many people use this product legitimately,” Grassley said. “I think it’s important that we at least make sure that our children do not have access to DHEA. So, the bill I introduced just last week will make the sale of DHEA to individuals under the age of 18 a civil offense.”

The need for the series of regulations was prompted by the release last week of the Mitchell Report, a report that identified several prominent professional Major League Baseball players who allegedly cheated by taking performance-enhancing anabolic steroids and/or human growth hormone supplements.

“The real tragedy of the Mitchell Report is that it shows how easy it is to beat the system,” Schumer stated. “The majority of players named in the report are accused of taking human growth hormone, a drug for which there is currently no reliable test. We have to do everything we can to keep dangerous substances out of young hands. Together, these two bills [the second bill would classify HGH as a Schedule III controlled substance] are a big step in that direction.”

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