FDA issues warning to consumers about tainted products sold in ethnic markets

08-Mar-2016 - Last updated on 08-Mar-2016 at 15:40 GMT

A screen shot from FDA's warning video for consumers. The video is posted in English, Spanish, Chinese, Korean, Tagalog and Vietnamese.

In a move widely applauded by industry groups, the Food and Drug Administration sent out a warning on a category of purported health products sold in ethnic communities that are subject to tainting with undeclared pharmaceutical ingredients.

The warning, issued yesterday, seeks to arm consumers against fraudulent products masquerading as dietary supplements or nonprescription drug products sold in ethnic or international stores, flea markets, swap meets or online. According to the warning, health scammers often target such outlets, preying upon populations with limited English or who feel more comfortable shopping in such settings.

Preying on ethnic preferences

“These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets," FDA expert Cariny Nunez said in the warning.

Indeed many of these products have shown up over and over in FDA warning letters about the inclusion of undeclared pharmaceutical ingredients, including sibutramine (a one-time prescription weight loss drug) in weight management products or various analogues of sildenafil or tadalafil (brand names Viagra and Cialis, respectively) in sexual enhancement products. Many industry observers, almost all of whom are English-first speakers and few of whom are closely connected with the ethnic market sales channel, often remark that the first time they hear about such products is when they read the warning letters.

The warning lays out for consumers why they should be cautious. Merida (sibutramine) was pulled from the market a number of years ago over health concerns, yet still shows up in these products. And even if an undeclared pharmaceutical ingredient might have been approved by FDA for sale under prescription, that does not mean that it is present in the flea market product in the correct dosage and matrix. And in any case, if a consumer does not know they are taking the drug, they cannot take precautions against counter indications, such as if they have a pre-existing heart condition.

Industry is on board

As they have often done, industry trade organizations were quick to applaud what they consider to be an appropriate FDA action. And the work the groups have done to make the case that products tainted in this way are not dietary supplements at all but are rather misbranded, illegal drugs seems to be gaining increasing traction at the agency; the warning uses quotation marks when saying products may be marketed as “dietary supplements.”

“We applaud FDA making consumers aware of potentially fraudulent products in the marketplace,” Steve Mister, president and CEO of the Council for Responsible Nutrition told NutraIngredients-USA.

“AHPA appreciates any and all efforts by FDA to call attention to unlawful products that contain undeclared drug ingredients,” said Michael McGuffin, president of the American Herbal Products Association.

Loren Israelsen, president of the United Natural Products Alliance, said that while his organization (as do the others) often rails at the current mainstream media perception that dietary supplements can pose serious health risks, in this subcategory of fraudulent products there is legitimate cause for concern.

“This is one of those areas within the dietary supplement horizon line where there is reason to be concerned. These are products coming through unorthodox channels of importation that are clearly not built to be compliant with US law. They are intended to be marketed to ethnic communities, and there is a vulnerability because FDA’s testing results for these types of products show that a disproportionate amount of them are spiked,” he said.

Warning is good; enforcement is better

The warning lays out for consumers some ways to help identify risky products, including those that claim to be all things to all people, products that rely heavily on florid testimonials, promises of quick fixes and products that claim to be “all natural.” In an effort to better serve these ethnic communities, the agency is posting translations of the warning in the following languages: Chinese, Korean, Spanish, Tagalog and Vietnamese. A short video warning in those languages has been posted, too. What would help even further is if FDA followed up the consumer warning with enforcement action, Mister said.

“We would hope that FDA would follow up with these sorts of markets with swift enforcement activity,” Mister said. “On one hand I agree with FDA’s approach to try to address the problem from the demand side to make consumers aware of the potential risks. On the other hand, it needs to be paired with some enforcement on the supply side so that people who might want to get into this market are aware that there are some real consequences.”

Vulnerability for industry at large

Israelsen noted that this ethnic channel is not only an issue for consumers but a potential black eye for the entire industry. Perhaps the most currently active and prominent critic of dietary supplements is Dr Pieter Cohen of the Harvard Medical School, and his ire and alarm over the state of the industry was first aroused by experiences he had in his day-to-day medical practice.

“It’s interesting to note that when Dr Cohen descibres how his interest began in dietary supplements he said it came from his work in Boston. He was seeing primarily Brazilian patients, many of whom were first generation immigrants. They were showing unusual signs and symptoms and he asked them what they were taking and had them bring the products in and he started to test them. He’d be the first to say that there is a problem with this category of products,” Israelsen said.

Interestingly, Portuguese is not one of the languages into which the warning has been translated.