Why Is Supplement Fraud A Growing Problem?
Key takeaways
- Poor regulation abroad harms U.S. consumers
- Beware of rogue E-Pharmacies
- The FDA's role is to take action against unsafe dietary supplement products in the U.S.
- WiseHuman provides free testing reports to prove our quality
Weak International Regulation Negatively Impacts US Consumers
Most international markets classify dietary supplements as food, and not drugs. This classification is the same as the US, but many of these international markets have even less regulation for dietary supplements than the FDA has in the US. Unfortunately, this lack of regulation leaves the door open for unscrupulous people or companies who take advantage of regulatory loopholes to advance products of dubious quality.
Counterfeit health products have historically been a problem in low-to-middle-income countries, but increasingly pose a threat in developed high-income countries.11 The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) estimates that 10 to 30% of the medicines in developing markets may be counterfeit! IMPACT estimates that developed markets see penetration of 1% by fraudulent dietary supplements, and this amount is rising.12
Beware Rogue E-Pharmacies!
Electronic/online pharmacies that traffic in adulterated or substandard nutritional supplements are even given a nickname, “rogue e-pharmacies”. An undetermined number of these rogue e-pharmacies operate overseas, where they can operate with less control and regulation. These companies send dietary supplements of doubtful quality to customers via mail and are responsible for an important percentage of the dietary supplement market.13
US Supplement Fraud Is Accelerating!
The popularity of Internet e-commerce is accelerating the rate of fraud in the United States market.13 IMPACT estimates that “medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases”12! Unscrupulous nutritional supplement manufacturers are distributing these products online at the biggest online marketplaces, as well as special e-pharmacies.13
From 2009 to date, the FDA has found nearly 1,000 fraudulent products in the U.S. market that contained hidden or mislabeled ingredients.14 Many of these dietary products were in the categories of weight loss, sexual enhancement, and bodybuilding, but some cases were categorized as “other”. Some of "other" cases include products tainted with pharmacologically active substances (aka, drugs). One of the products alone contained five hidden substances: chlorzoxazone, nefopam, diclofenac, ibuprofen, naproxen, indomethacin!
In 2019, the FDA acted against 17 companies (foreign and domestic) for illegally selling products claiming to treat Alzheimer’s disease, with more than 50 products containing unapproved and misbranded drugs.15
How Does The US FDA Fight Fraud?
The FDA has the responsibility to act against any unsafe dietary supplement product that comes on the U.S. market.16 The FDA handles fraud investigations through its Office of Criminal Investigations. Enforcement actions may include injunctions, seizures, administrative detentions, and other legal measures. This office can also bring in the U.S. Department of Justice if consumer health is at risk.