Thursday 29 June 2017

Two New Studies Debunk Benefits of Multivitamins; What is the Impact on Industry?

Two studies released on Monday gained national headlines for their findings on the effectiveness of multivitamins.  The two studies found multivitamins didn’t protect aging men’s brains or help heart attack survivors. At Harvard researchers focused on long-term multivitamin support for brain health, in particular questioning their role in mitigating or dealing Alzheimer. The study examined 6,000 male doctors age 65 or older who were part of a larger study. The men were given either multivitamins or a placebo. The study found that after a decade of supplementation the vitamin-takers showed no difference on memory or other cognitive tests.

The second study looked at a broader range of ailments. The Physicians Health Study II examined 15,000 healthy male doctors age 50 or older. It found those who supplemented their diet with a multivitamin had a slightly lower risk of cancer and cataracts. The vitamins, however, did not have an effect on the risk for heart disease.  For more on the studies click here.

The impact for industry is mixed. All dietary supplements sold in the US must support the health and structure/function claims made for the products. Supporting claims is both a Food and Drug Administration and a Federal Trade Commission (FTC) regulation. Supporting claims not only avoids regulatory enforcement, but also provides a defense from plaintiffs litigation. Dietary supplement companies are routinely targeted by plaintiff’s lawyers claiming the product failed to work as claimed. The demand letter will cite to counter studies and seek a settlement out of court. The studies released on Monday will no doubt find their way into some demand letter, which the need to provide an equally credible counter study to provide a defense.

The good news from the study is that it found no adverse events or consequences from supplementation. In an industry plagued with regulatory violations and recall this is welcome news. The new studies likely won’t tamper growth in this billion dollar industry, but it will likely provide new fodder to plaintiff’s lawyers writing demand letters for supplements focused on memory and heart health.

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