FDA warns niacin marketers about drug claims

By Shane Starling

- Last updated on GMT

Related tags: Atherosclerosis

"Clinically proven, trusted niacin delivery"? Not according to the FDA
"Clinically proven, trusted niacin delivery"? Not according to the FDA
The Food and Drug Administration has affirmed the principal that references to scientific studies can amount to drug claims under the Federal Food, Drug, and Cosmetic Act (FDCA).

In a January 19, 2011, warning letter to Minnesota-based Upsher Smith Laboratories, the FDA rapped the company over scientific web references that were linked cardiovascular and cholesterol benefits for the company’s niacin-based dietary supplements. Upsher Smith Laboratories has subsequently taken the website for Slo-Niacin products offline.

“The therapeutic claims on your website establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,”​ wrote FDA director from the Minneapolis District, Gerald J Berg.

Diseased citations

Berg went on to highlight the problem of companies referencing scientific studies in online marketing materials.

“Furthermore, the ‘References’ and ‘In the News’ sections of your website for this product cite a number of articles about the usefulness of the ingredient niacin in treating and preventing diseases,”​ he wrote.

“When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C),​ [of the FDCA] a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.​”

Claims at stake

Claims being made on the retracted site included:

  • SLO-NIACIN…Reduced risk of cardiovascular events* when combined with a statin
    • SLO-NIACIN…Halted stenosis progression when combined with a statin.
    • Niacin is clinically proven to help manage cholesterol levels, a major factor in heart health
    • SLO-NIACIN Offers an affordable option for Cholesterol Management
    • Niacin is the oldest of today’s commonly used agents for lowering cholesterol
    • See how…niacin complements statin therapy for heart health

The FDA cited numerous examples of studies that contributed to disease marketing including a 1992 study published in the American Journal of Cardiology titled: ‘Marked benefit with sustained-release niacin therapy in patients with ‘isolated’ very low levels of high-density lipoprotein cholesterol and coronary artery disease.’

The letter qualified the drug accusations by noting that Slo-Niacin did not have generally recognized as safe (GRAS) status for use as a food ingredient.

It also highlights several images used on the Slo-Niacin website that can also, “be considered as a claim to diagnose, mitigate, treat, cure, or prevent disease if in the context of the labeling it suggests that the product has an effect on a disease or diseases.”

Niacin, vitamin B3, has been shown to benefit atherosclerosis at high doses by reducing total cholesterol, triglycerides, very-low-density lipoprotein, and low-density lipoprotein.

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1 comment

why niacin?

Posted by denise cordes,

niacin dramatically increased my hdl with a lesser impact on my ldl. took awhile for the flushing to go away at the high dose i use but i cannot tolerate statins. those drugs are poison and the fda should be vigilant in monitoring these meds for side-effects and efficacy in actually reducing the number of hear attacks.

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