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Fraudulent Dietary Supplements Highlighted in the 2016 National Consumer Protection Week

In case you hadn’t heard about it or didn’t get involved in any of the events hosted by various campaign members, the week of March 6-12 was National Consumer Protection Week.  Besides the usual efforts to educate the public about our basic rights as consumers, the risks of identity theft, and certain types of scams such as crimes aimed at seniors and other vulnerable populations, this year’s campaign included a significant focus on fraudulent and unsafe dietary supplements.

First, U.S. Attorney General Loretta Lynch recorded a video message as part of National Consumer Protection Week that highlighted the Justice Department’s (DOJ’s) recent work against fraudulent, deceptive, or unsafe dietary supplements.  Her verbal statements noted that DOJ has partnered with other federal law enforcement agencies to make the policing of such products a priority and that, in 2015, over 100 civil and criminal actions involving fraudulent or unsafe "supplements" were filed (in some cases, the products were so unlawfully marketed that I hesitate to label them as actual dietary supplements).  In the video, Attorney General Lynch talks about too-good-to-be-true claims that a product can cure a serious disease as being an “abuse of consumer trust” and takes companies to task for being greedy and willing to prey on very sick people.  But she also encourages consumers to become more educated and informed, laying out some concrete steps people can take to confirm the safety and appropriateness of a dietary supplement.

In addition, the Food and Drug Administration (FDA) used the occasion of this year's Consumer Protection Week to launch a new initiative on supplement safety -- available through www.FDA.gov/SupplementSafety -- that provides information for consumers in English, Spanish, Simplified Chinese, Korean, Vietnamese, and Tagalog.  The multimedia initiative consists of a video and a consumer-focused article that explains the dangers of imported, tainted products falsely marketed as dietary supplements and targeted at specific ethnic groups or other populations that may be vulnerable to health fraud scams.  Some of the consumer safety concerns cited by FDA include that:

  • Imported products marketed as “dietary supplements” or non-prescription drugs may be contaminated or contain undeclared, potentially harmful drug ingredients.
  • Such products may claim to prevent, treat, or cure serious conditions like cancer, HIV/AIDS, or diabetes, and their use may lead to very sick patients not getting the medical treatment they actually need.
  • Similarly, products may be labeled as “antibiotics” but not actually contain any antibiotic activity – potentially spreading a bacterial infection and keeping the patient from recovering from her illness. On the other hand, products that are antibiotics but are sold without a prescription may be used inappropriately, further contributing to the growing problem of antibiotic resistance worldwide.

Dietary supplement manufacturers, distributors, and marketers should take heed of the increased scrutiny being placed on the industry as a whole in light of the actions of a few unscrupulous people and, as always, ensure that your business practices and products meet (or even exceed) all applicable requirements.  And in light of the fact that we are all consumers in addition to being involved with the consumer-products industry, these reminders from FDA and Attorney General Lynch are good for us to keep in mind too as we go about our purchasing lives!

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.