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Regulatory Focus™ > News Articles > FDA in Crackdown Against Diabetes Companies for Marketing Unapproved Drugs

FDA in Crackdown Against Diabetes Companies for Marketing Unapproved Drugs

Posted 23 July 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) seems to be on a major kick against unapproved and misbranded diabetes drug products, according to the most recent batch of Warning Letters released on 23 July 2013.

Start of a Crackdown

FDA often uses batches of Warning Letters to make an enforcement point against practices it does not favor. Rather than releasing 10 Warning Letters over 10 weeks, it may concentrate them all into a single week in the hopes of making a statement. In the last few years, the practice has been used to call attention to cosmetic manufacturers using drug claims, manufacturers of unapproved flu products, unregistered foreign facilities exporting to the US, and supplement manufacturers exercising insufficient oversight over contract manufacturers.

On 23 July 2013, FDA released 10 Warning Letters, most of which appeared to be geared toward smaller "natural health"-type firms marketing diabetes products.

Despite their small size, however, some of them were found by FDA to be peddling outsized and egregious claims.

One letter, for example, to Anastasia Marie Laboratories of Oklahoma City, OK, claimed one of its products, marketed to treat diabetic neuropathy, was "FDA-approved" to relieve foot and leg pain. The problem, FDA wrote, was that it actually had no such approval.

"Your product is not the subject of a FDA-approved application and therefore connoting FDA approval is a false statement that misbrands your product," the agency wrote in the Warning Letter. "Introduction of such product into interstate commerce is prohibited under § 301(a) of the FD&C Act [21 U.S.C. § 331(a)]."


The majority of other letters cite unapproved claims made with respect to unapproved products. Many of the letters cite patient testimonials on the websites of the respective companies, such as the letters to Internal Remedies, PharmaTerra, Nature's Health Supply, Magnilife and Neuliven Health.

Other companies, including Hi-Tech Pharmacal and Health King Enterprise & Balanceuticals Group made more straightforward - though still prohibited - claims about the efficacy of their respective products.

The Warning Letter to Magnilife was also notable in that it references a product type not often seen in Warning Letters: Homeopathic products. FDA's letter takes care to note that while most homeopathic drugs fall outside its usual marketing purview and are instead overseen by the Homeopathic Pharmacopeia of the US (HPUS), because diabetes is not a self-limiting disease amenable to self-diagnosis, any homeopathic product intended to treat diabetes must be marketed as a prescription product.

Finally, one Internet-based company (which FDA seems to misidentify as the registration proxy, perhaps in lieu of being able to positively identify the owners of the website), was accused of marketing an unapproved version of the diabetes drug Januvia. FDA said it conducted a straw purchase of the drugs through the company's website, and was also given free pills of a generic variant of the drug Viagra. The company's products were apparently marked with a "For Sale in India only - Not for Export" label, and FDA noted that the drug should never have been sold outside of India.

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