Placebo supplement spawns opposition

By Lorraine Heller

- Last updated on GMT

Related tags: Dietary supplement, Food and drug administration, Placebo

A placebo dietary supplement aimed at soothing children's pains has
been criticized as being 'unlawful' and 'unethical'.

The sugar pill, marketed by Efficacy Brands, was introduced on the US market in March this year, and is currently being sold at $6 for a bottle of 50. The product is called Obecalp - or 'placebo' spelt backwards. The idea behind the cherry-flavored pill is to allow parents to play on the 'placebo effect' as a way to soothe their children's aches and pains in the event that medicine is not needed. The placebo effect is what occurs when people feel better because they believe they have been given come kind of treatment. However, the product has been received with a general rumbling of suspicion and criticism from representatives in the supplement industry, the scientific and legal community, and even the US regulatory agency Food and Drug Administration (FDA). Industry opposition "This is not a lawfully marketed product, and it shouldn't be on the shelves at all,"​ said Daniel Fabricant, PhD, science and regulatory affairs vice president at the Washington DC-based Natural Products Association (NPA). "Basically, the only time you have a placebo is when you're running a clinical study. By calling a product a placebo you are indicating that you're treating something. It is consumer fraud,"​ he told NutraIngredients-USA.com. Beyond the legal implications, there is also a strong ethical argument against such a product. The Council for Responsible Nutrition (CRN), another supplement industry group, said: "In general, we have concerns with a supplement product - particularly a placebo - being marketed as a therapeutic substitute for pharmaceuticals, particularly without the advice of a physician or other healthcare professional."​ Such a product would also encourage children to believe that pills solve everything, said Dr Douglas Kamerow, an associate editor of the British Medical Journal in comments made to the BBC. Legal doubts ​According to Ivan Wasserman, an FDA and FTC compliance lawyer and partner at Manatt Phelps & Phillips in Washington, DC, the product presents "some very tricky regulatory conundrums".​ By claiming it has certain therapeutic benefits, it may be more appropriate to regulate it as a drug, he explained. However, in this case it would have to go through FDA approval, and 'efficacy' would need to be demonstrated, he said. "Similarly, if claims are made in advertising, the FTC would require that the company possess adequate scientific substantiation for any efficacy claims. While the 'placebo effect' has been documented, it is unclear whether the FTC would allow the company to rely on general literature or require some evidence of the efficacy of this particular product." Regulatory concerns ​Although FDA was unable to give a formal comment before a clear examination of the case, an agency spokesperson did express doubts that such a product would meet the legal definition of a dietary supplement as contained in the Dietary Supplement Health and Education Act of 1994 (DSHEA). This defines a dietary supplement as a product that is "intended to supplement the diet". ​ It must contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients. ​Previous legal cases also provide an indication on the general position of the Federal Trade Commission, which regulates product marketing. In an FTC case vs. Q-ray magnetic bracelets, it was upheld that "if a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer".​ ("See Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir.1992) (a statement violates the FTC Act "if it is likely to mislead consumers, acting reasonably under the circumstances, in a material respect".) Efficacy Brands did not respond to calls for comment in time for publication.

Related topics: Regulation

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