March 10, 2003 – In the United States, the days of unscrupulous dietary supplement makers are numbered.
New regulations put forward by the Food and Drug Administration (FDA) would indeed guarantee consumers that their dietary supplements contain the dose of active ingredients indicated on the packaging and are of good quality. Currently, US law allows manufacturers to sell their products without having to prove that they are safe or effective, or even that they actually meet the amount of active ingredients promised.
The FDA believes that about a thousand dietary supplement manufacturers share a market valued at US $ 19 billion annually.
The proposed new rules are a hybrid of those already regulating the trade in edible foods and medicines. They would force manufacturers to ensure that their products actually contain the advertised dose and do not contain any dangerous ingredients.
In the past, tests1 demonstrated that some products actually only offered one-third of the dose promised on the packaging, or that they had been contaminated with substances as dangerous as lead2.
However, with these new rules, the FDA would only vouch for the quality of dietary supplements, not their efficacy or safety. The FDA does not claim, for example, that ipriflavone tablets actually fight osteoporosis or can be taken without precautions; it only ensures that what is indicated on the packaging will be found inside.
In Canada, the Natural Health Products Directorate (NHPD) is currently finalizing the creation of the new Proposed Natural Health Products Regulations3. This regulation, which could be adopted in the coming months, would affect six general areas of possible impact: product registration, facility approval, good manufacturing practices, product labeling and packaging, reporting of adverse reactions and clinical trials.
The FDA’s proposal will be debated over the next few months, and final regulations are expected to be passed next year. Already, nearly a hundred manufacturers governed by voluntary quality standards have applauded the government’s desire to “clean up” the environment.
Jean-Benoit Legault – PasseportSanté.net
According to CBSNews.com and CNN.com, March 10, 2003.
1. There are reviews of homeopathic products on the site (paying): www.consumerlab.com
2. Barth A, Schaffer AW, Osterode W, Winker R, Konnaris C, Valic E, Wolf C, Rudiger HW. Reduced cognitive abilities in lead-exposed men.Int Arch Occup Environ Health 2002 Aug; 75 (6): 394-8. [Consulté le 10 mars 2003].
3. Description of the proposed regulation on natural health products: www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/bit_survey_intro_e.html [Consulté le 10 mars 2003].
