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FDA Warning Concerning Ethnic or Imported Supplements and Nonprescription Drugs

By: NCSF  on:  Mar 29 2016
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The FDA recently released a public warning concerning imported dietary supplements and nonprescription drug products. According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), dietary supplements scammers often target advertising to people who prefer to shop at “nontraditional places” such as ethnic or international stores. The aforementioned consumers often are purchase motivated by magazines, infomercials, flea markets or online marketing; especially those who have limited English proficiency and access to health care information. “These scammers know that ethnic groups who may not speak or read English well, or who hold certain cultural beliefs, can be easy targets,” Nunez says. For example, some Native Americans, Latinos, Asians and Africans may have a long tradition of relying on herbal or so-called “natural” remedies for ailments. Many advertisers put the word “natural” somewhere on the package, knowing it inspires trust in certain groups. One must remember that “natural” does not mean safe - as many natural substances and plants throughout the globe are toxic or deadly to humans. Other suspicious buzzwords can include “doctor recommended” or “physician approved”.

Gary Coody, R. Ph., the FDA’s national health fraud coordinator explained that many of these products claiming to be “natural” are often contaminated with hidden and potentially-harmful drug ingredients and chemicals not listed on the label. And even if the product contains an ingredient seen in an FDA-approved drug product, this does not mean it is safe in the dosages or amounts used in a nonprescription product. Scammers often seek out ethnic populations who are overweight or have serious conditions such as cancer, diabetes, or heart disease. They target consumers looking for easy and inexpensive solutions to difficult problems, playing on their fantasies of a “quick fix”. Others illegally sell imported antibiotics without a prescription or physician oversight. According to Coody, this can easily lead to misuse and overuse, a key factor contributing to antibiotic resistance. Conversely, some of these products do not actually contain any antibiotics.

Products are often advertised as coming from a specific country or region to gain the trust of that consumer base; but by the same token, products with the claim “Made in the USA” may not be made here. Consumers sometimes see this claim as an assurance of safety, Coody says, but any scammer can slap the label on without any legal review. The law does not require companies who make dietary supplements to get FDA approval before marketing their products. “Remember, dietary supplements are not drugs,” Coody says. “They are not substitutes for the drugs your health care professional prescribes. And you should let your health care professional know what supplements you are taking, because they may interact in a harmful way with prescribed medications or keep a prescribed drug from working.”

The FDA recommends avoiding nonprescription health products that focus on the following claims as these are potential red flags of fraudulent advertising and practices:

  • One product does it all: Be suspicious of products that claim to provide wide ranging health.
  • “Independent research”: Clinical trials within prestigious circles are implemented for many legitimate products. Scientifically-valid information is quite welcome and exchanged amongst the top researchers and scientists. This lends itself to question why supplement “research” is often performed independently of these circles if it is actually valid.
  • Personal and celebrity testimonials: Success stories such as “I feel younger and more vigor,” are easy to make up and are not a substitution for scientific evidence.
  • Pharmaceutical appearance: Some companies use pharmaceutical labeling so that their products appear similar to what one would get after fulfilling a prescription with their local pharmacy. This is again a ploy to instill unwarranted trust in the product.
  • Free trial give-away: Some companies will claim their product so effective that they will give it away for a number of months because they are confident the consumer will continue using the product long-term. This is usually just an effective way to make money on shipping and handling charges.
  • Quick fixes: Few diseases or conditions can be treated in a rapid fashion. Beware of language such as “lose 30 pounds in 30 days”.
  • “All natural”: Some plants found in nature will cause death to humans if eaten; this slogan is not synonymous with safe.
  • “Miracle cure”: Consider this claim or others like it such as “new discovery” or “scientific breakthrough” as major red flags. A real cure for a serious disease would be all over the media and prescribed by doctors - not buried in TV infomercials or on sale-based websites.
  • FDA-approved: Domestic or imported dietary supplements are not approved by FDA.

Check the FDA’s website to see if the agency already has a history of fraudulent or dangerous practices.

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