US bid to take action against 'fertility' supplements
Dr Katie Howe
Progress Educational Trust26 November 2019
A health watchdog group has petitioned US regulators to take action against the manufacturers of 39 dietary supplements that claim to aid fertility.
The non-profit watchdog, the Centre for Science in the Public Interest (CSPI), carried out a review and found no scientific evidence that that the products increase chances of conceiving. The CSPI have called on the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to prohibit the sales of the products.
'Supplement manufacturers marketing fertility aids are making promises on which they can't deliver. They are selling false hope. They are preying on a vulnerable population. And they are diverting women away from treatments that actually have FDA approval and scientific evidence of effectiveness,' said CSPI president Dr Peter G. Lurie.
In its year-long review, the CSPI identified 39 women's fertility supplements containing 94 different ingredients manufactured by 27 different companies. None of the manufacturers provided any scientific evidence to support their claims that their products help women become pregnant.
Under US law dietary supplements may be sold without proof of safety or efficacy, but manufacturers are only allowed to make general health claims. Claiming that a product helps a specific medical condition is prohibited unless there is supporting evidence.
The products, which have names like Pregnitude, OvaBoost, and Pink Stork, make specific claims such as 'formulated for women to get pregnant' and 'boost your chances of conception'.
The CSPI says the products meet the FDA's definition of 'health fraud products' as they do not provide reasonable scientific evidence and asked the FDA to send warning letters to the manufacturers, prohibit the sales of the supplements and allow inspectors to seize the products.
The watchdog carried out a review of evidence on the manufacturers' websites found that four of the studies cited showed no increase in pregnancy rates and four others did not even assess pregnancy rates.
When contacted by email, 11 manufacturers did not reply and 16 cited no supportive evidence. Four cited customer reviews as evidence and three cited studies that showed no increase in pregnancy rates. One company referred to a clinical trial, published in 1942, that showed 12 of 16 previously infertile women conceived after taking a compound in folic acid. However, the study was carried out in men not women.
FTC spokesman Mitchell Katz said the agency does not comment on letters received from external parties. However, FDA spokesperson, Lindsay Haake, told Natural Products Insider: 'The agency takes these concerns seriously and intends to follow up on the information provided in this letter. The FDA is committed to doing everything within its resources and authorities to identify and remove unsafe and otherwise illegal products from the market.'
SOURCES & REFERENCES
|Calling for federal action, watchdog says there’s no evidence dietary supplements for infertility help women get pregnant|
|STAT | 18 November 2019|
|‘Fertility’ supplements lack scientific evidence, marketed as drugs, watchdog group says|
|Natural Products Insider | 21 November 2019|
|Manufacturers of “Fertility” Supplements Selling False Hope|
|Science in the Public Interest | 15 November 2019|
|Nonprofit Calls on FDA to Take Enforcement Action on 39 Fertility Supplements|
|Regulatory Focus | 18 November 2019|
Reproduced with permission from BioNews, an email and online sources of news, information and comment on assisted reproduction and genetics.