A prominent US researcher has accused America’s Food and Drug Administration of a ‘dereliction of duty’ after a new study found serious shortcomings in the way it deals with contaminated dietary supplements.
Contamination of supplements – most notably sports, weight loss and sexual enhancement products – has been a growing problem in the US, and one that has tarnished the reputation of the wider supplements industry. Adulterated supplements are believed to be responsible for an estimated 23,000 emergency department visits.
The FDA is the organisation tasked with identifying and removing hazardous supplements from the marketplace (although it is not responsible for assessing the safety of products before they are place on the market).
A new study by Tucker and colleagues, published this month by JAMA, found that between 2016 and 2017 the FDA identified 746 brands of supplements adulterated with pharmaceutical agents, including prescription medications such as sildenafil and fluoxetine, withdrawn medications including sibutramine and phenolphthalein, and unapproved drugs including dapoxetine and ‘designer steroids’.
Due to the seriousness of the potential public health risk of inadvertently ingesting unknown quantities, the FDA operates a system of requesting that suppliers voluntarily recall product, which – if the company agrees – is accompanied by email alerts and postings on the FDA’s website.
But the current study found that of the 746 cases of supplement contamination only 360 (48%) were actually recalled. In a commentary on the subject, Harvard Medical School professor Dr Pieter A Cohen asks why the FDA “fulfilled its responsibilities less than half the time”?
Cohen argues that the FDA is simply failing to use the full range of powers at its disposable. For example, if a company refuses to recall their products the FDA can use warning letters to pressure that company into action – but in the case of the current study period, where 140 companies were involved, just seven warning letters were sent. It can also order a mandatory recall or make a referral to the US Department of Justice. But according to Tucker and colleagues the agency made no mandatory recalls and only one Department of Justice investigation in response to the 746 brands of adulterated supplements.
Cohen asserts that findings of the latest study are “consistent with prior research that has highlighted major deficiencies in the FDA’s regulation of supplements”. He says this amounts to a “dereliction of duty” on the part of the agency that is “leaves consumers’ health at risk”.
Cohen is calling for new measures to tackle the issue of contaminated supplements, which he says will “require more than FDA action”. He writes “One practical change would be to require firms to register supplements with the FDA prior to sale and Congress could provide the FDA with more effective enforcement tools such as immediately revoking a product’s registration if a supplement is found to be adulterated with pharmaceutical drugs.”