Consumer Health Digest #02-46

November 12, 2002

Your Weekly Update of News and Reviews
November 12, 2002

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

American Medical Association blasts lack of “dietary supplement” regulation. On October 8, at a U.S. Senate hearing on dietary supplement safety, an AMA board member, listed four questions that must be addressed in assessing the extent to which the public is protected against products that are ineffective or dangerous:

  • Do dietary supplement products actually contain the active ingredient(s) (and strength[s]) that their manufacturers claim on the labeling?
  • Are these products really as safe as the promotional materials of the manufacturers claim them to be?
  • Does the degree of safety change in individuals who have preexisting diseases and conditions, or in those individuals who are also taking prescription medications?
  • Are the structure/function claims for these products accurate and based on good science?
  • Are these products being used inappropriately to treat diseases or potentially delaying individuals with diseases from obtaining effective care that may include prescription medications?

Concluding that no satisfactory answers exist for any of these questions, Davis stated:

Because dietary supplements are classified as foods rather than drugs, rigorous safety and efficacy standards are not required for these products. Also, standards for product quality and for Good Manufacturing Practices (GMP) do not yet exist.

The primary obstacle to effective regulation in this area is the Dietary Supplement Health and Education Act of 1994 (DSHEA), which fails to provide for adequate Food and Drug Administration (FDA) regulatory oversight of dietary supplements.

[Davis R. Statement for the record of the American Medical Association to the Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia Committee on Government Affairs, United States Senate, Re: Dangers of dietary supplement ephedra. Oct 8, 2002]

DSHEA’s passage was spearheaded by a massive lobbying campaign organized by the marketers of dietary supplements and herbs. Although claimed to increase consumer protection,DSHEA’s real purpose was to cripple FDA regulation of these products. Although the October 8 hearing was focused on adverse reactions to ephedra products, low-quality products and misleading claims are rampant throughout the “dietary supplement” marketplace. The public cannot be protected unless DSHEA is repealed and federal regulation is toughened. [Barrett S. How the Dietary Supplement Health and Education Act of 1994 weakened the FDA. Quackwatch Web site, revised May 18, 2002]

Osteopath agrees not to make unsubstantiated claims for alleged anti-snoring spray. Robert M. Currier, D.O., of Alpena, Michigan, who appeared in infomercials for SNORenz, has agreed to settle Federal Trade Commission charges that he made unsubstantiated claims about the product. The FTC also charged that Currier had: (a) falsely represented that clinical research has proved that SNORenz worked, (b) failed to disclose that the product is not intended to treat sleep apnea (a life-threatening disorder in which the person stops breathing) and that persons experiencing sleep apnea should seek medical attention, and (c) had failed to disclose his material connection to the product’s manufacturer. The agreement bars him from making unsubstantiated claims that SNORenz or any other food, drug, or dietary supplement:

SNORenz is a throat spray consisting of oils and vitamins. Last year, its principal marketers settled FTC charges that they lacked adequate substantiation for their claims. The consent agreements included the manufacturer (Med Gen, Inc., of Boca Raton, Florida and its principal, Paul Kravitz) and an infomercial maker (that Tru-Vantage International, LLC, based in Niles, Illinois). The agreements forbid the parties from making unsubstantiated claims that SNORenz or any other food, drug, or dietary supplement reduces or eliminates snoring or eliminates, reduces, or mitigates the symptoms of sleep apnea. SNORenz was promoted through 30-minute infomercials produced first by Tru-Vantage International and later by Med Gen itself. The product claims also appeared on its labels, on Med Gen’s website, and on many other Web sites. [Promoters of dietary supplement that purports to treat snoring agree to settle FTC charges. FTC news release, March 29, 2001]

Medical Letter comments on generic drugs. The Medical Letter on Drugs and Therapeutics has concluded that the vast majority of FDA-approved generic drugs are bioequivalent to their brand-name counterparts. Those validated in humans or considered inherently valid are rated “A.” Drugs approved on the basis of chemistry, manufacturing controls, and laboratory solubility tests are given a “B” rating. The article lists all 39 “B”-rated drugs and states that they represent fewer than 3% of marketed generics. [Generic drugs. The Medical Letter 44:89-90, 2002.]

Several tobacco control ballot measures succeed. Bill Godshall, who publishes an e-mail newsletter about tobacco control, has reported that last week’s election contained several significant victories for tobacco control advocates:

  • Florida voters approved (70.8% – 29.2%) an amendment to require smokefree policies in all restaurants and other enclosed workplaces throughout the state, except for stand alone bars.
  • Arizona voters (by a 2-1 margin) voted to increase the state’s cigarette tax from $.58 to $1.18 per pack and to increase the tax rate on other forms of tobacco, with the new revenue to fund tobacco control and healthcare programs.
  • Salina (Kansas) voters rejected (59% – 41%) a referendum that would have repealed the city’s recently enacted smokefree ordinance.
  • Washoe County (Reno, Nevada) voters approved (59% – 41%) an advisory referendum to let local governments enact smokefree laws that are more protective of public health than the existing state law that preempts local smokefree laws.
  • Washoe County voters also approved (67.88% – 32.12%) an advisory referendum for a statewide smoking ban in restaurants and many other workplace.

 


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