Natural products in the United States: alarm bells ringing

Are the new natural health product regulations better protecting consumers here?

“Yes”, answers without hesitation Pierre Haddad, full professor in the Department of Pharmacology at the University of Montreal. “A survey of consumers revealed that consumers have three demands on natural health products (NHPs): quality, safety and efficacy. The new regulations set very clear guidelines on these three points, while putting safety at the forefront. »Thus, by the 1^er June 2006, manufacturers and distributors of raw plants and extracts produced in the traditional way will have to provide the Natural Health Products Directorate (NHPD) with a marketing application for their product providing, among other things, safety information of their products, otherwise, they will simply be withdrawn from the market. Submission dates vary depending on the type of NHP: for example isolates, amino acids and fatty acids not prepared in the traditional way will have to comply by 1^er January 2005, vitamins and minerals, by 1^er January 2007 and homeopathic products by 1^er June 2007.

“The new regulations also oblige the industry to report to the NHPD every two weeks any major side effect related to one of its products and to submit an annual report in this area”, underlines Jean-Yves Dionne, pharmacist. This is another big difference with the United States where industry is not required to disclose this information. It was therefore necessary for the FDA to start a legal battle so that in 2002, a manufacturer of ephedra supplements was obliged to provide it with documents concerning the thousands of side effects reported by consumers. The IOM report finds this situation unacceptable and recommends that the government oblige the industry to report all cases of adverse reactions that come to its attention.

The NHPD now requires, among other things, that companies adhere to manufacturing standards that will ensure the quality of supplements available on the market. “In the United States, nothing like this is required. In 1994 when the DSHEA came into effect, the authorities thought that the industry would discipline itself, but some manufacturers took advantage of it by putting anything on the market, says Jean-Yves Dionne. The new Canadian regulations create a framework that will prevent such abuses. It better protects consumers and allows them to get their money’s worth. Among other things, each company will need to have an on-site employee who is properly trained in quality control.

The Canadian approach is avant-garde, because it advocates an attitude that is both open and rigorous, according to Pierre Haddad. “Open, because, for example, the NHPD has chosen to take into account the knowledge accumulated by other health approaches, such as traditional herbalism, homeopathy or traditional Chinese medicine, rather than dismissing them out of the blue. hand. Rigorous, because regulations require the industry to meet high standards. “All without falling into the prohibition or excessive alarmism as desired by some American organizations whose tolerance threshold is very low. Indeed, some of the cases of toxicity noted by Consumer Reports, ephedra, lobelia and kava in particular, are linked to the intake of dosages much higher than those recommended by practitioners. “Canada does not want to prevent the sale of certain products, but rather to force clear labeling,” continues Pierre Haddad. “It’s all a question of dose and quality control,” says Jean-Yves Dionne. So rather than banning ephedra supplements altogether, Canada has instead limited their ephedrine content to 8 mg per dose and their dosage to 32 mg per day. Rather than banning all species of aristolochia, Pierre Haddad thinks it would be more logical to force manufacturers to market products with zero or very low levels of aristolochic acid. “Regarding organ or gland extracts, the risk of mad cow disease is only theoretical, because these extracts are not made from organs at risk (brain, marrow, for example), they are highly purified and the dosages are generally low. However, it is true that certain natural supplements could be offered only under prescription in order to force the medical follow-up ”, suggests Jean-Yves Dionne.

In the Consumer Reports article that sounds the alarm, we are surprised that the FDA spends proportionately much less money on the control of supplements than on drugs. Members of Congress and the Senate have also undertaken to correct this situation by proposing additional budgets to allow American regulations to have more teeth. “It is true that it is not because a supplement is natural that it is automatically safe, warns Jean-Yves Dionne, but let’s set the record straight: drugs are much more dangerous than natural products. and that’s why they are watched very closely. Let us not forget that each year the side effects of drugs cause, in Quebec alone, 40,000 hospitalizations ”.

Françoise Ruby – PasseportSanté.net

References
Consumer Reports, May 2004. Dangerous supplements: still at large. http://www.consumerreports.org
NewScientist.com. Special Report: a health fad that’s hard to swallow. http://www.newscientist.com/
Institute of Medicine, April 2004. Dietary Supplements:A Framework for Evaluating Safetyhttp://www.iom.edu/report.asp?id=19578
Natural Health Products Directorate, March 2004. Natural Health Product Compliance Guide. http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn
HerbalGram, issue 61. Congress Increasingly Active on Herbs and Dietary Supplements.