FDA rebukes 17 firms for selling Alzheimer's drugs illegally

The Food and Drug Administration announced plans Monday to step up its policing of dietary supplements, which it said has mushroomed into a $40 billion industry with more than 50,000 products.

In contrast in Canada, Health Canada said it assesses natural health products "for safety and efficacy, so claims made about their use to diagnose, prevent, mitigate, or treat a specific disease can be substantiated".

Supplements are big business, as three out of four Americans consume some type of dietary supplement, such as a daily vitamin or herbal supplement, as part of their regular routine.

As is well known, there is no cure for Alzheimer's disease, which the FDA spelled out in its warnings Monday.

"As the popularity of supplements has grown, so have the number of entities marketing potentially unsafe products, or making unproven or misleading claims about the health benefits they may deliver", he noted.

In what's been interpreted as a nudge to lawmakers to boost the FDA's authority over supplement makers, Gottlieb pointed out just how much the supplement industry has changed and grown since Congress passed the Dietary Supplement Health and Education Act in 1994.

In the USA, dietary supplements are considered to be food products.

The Alzheimer's Association says there is a "growing number" of alternative treatments, including dietary supplements, that are "promoted as memory enhancers or treatments to delay or prevent Alzheimer's disease and other dementias". It also said it's developing a way to more quickly and consistently alert people about supplements that might have illegal ingredients.

The trade group that represents supplement manufacturers applauded any effort by the FDA to take what it calls "bad actors" out of the marketplace.

"All [natural health products] products for sale in Canada must have a NPN or a DIN-HM that consumer can look for to assure the product is approved for sale in Canada", Maryse Durette, a spokeswoman for Health Canada, said in an email.

A study published in October found that almost 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, based on an analysis of FDA data.

He added the FDA will be engaging the public in dialogue around the topic of supplements and will announce more details of its oversight plan in the "near future". The companies have 15 days from the receipt of the letters to tell the regulator how they will correct the violations.

"As soon as you have an environment where you can say supplements are good for your brain and you don't need clinical data to support that, then you've got an environment that's ripe for fraud", Cohen said.

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