FDA rebukes 17 firms for selling fake Alzheimer's drugs

Marco Green
February 12, 2019

The US Food and Drug Administration is taking new action against dietary supplements, sending warning letters to companies who claim, without proof, that their products can prevent or treat Alzheimer's, diabetes and cancer, the agency announced Monday. FDA Commissioner Scott Gottlieb explained that the supplement market may have outpaced the agency's ability to properly regulate the volume and variety of products hitting the market, and that the agency is working toward more rapid response methods of issuing consumer warnings and halting the production and distribution of products marketed using fraudulent claims to prevent or cure conditions that can not be treated with over-the-counter supplements.

Gottlieb added that he's concerned that "changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks". The companies have 15 days from the receipt of the letters to tell the regulator how they will correct the violations.

Roughly three-quarters of American consumers regularly take dietary supplements - including four out of five older adults, Gottlieb said.

Q: Does the FDA plan to change that rule?

The FDA's dietary supplements review group has 23 employees, he said, and is planning more oversight on products that make illegal health claims. In recent months, the agency has also gone after a number of other products, including male enhancement supplements and those claiming to treat opioid addiction. Supplement makers can make claims similar to what's found on cereals in the USA such as "calcium builds strong bones".

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.

Health Canada already issues advisories, warnings and recalls about natural health products. He said dietary supplements are regulated like foods because they pose less of a risk than drugs.

"It's very hard to take on this industry comprehensively when the law shackles the agency to the extent that it does", he said. That's one of the moves the USA aims to do introduce with the FDA's announced modernization of dietary supplement regulation and oversight.

Dr. Pieter Cohen, an associate professor at Harvard Medical School, said dietary supplements are unnecessary for most people unless a doctor recommends them for a specific reason.

Other reports by Click Lancashire

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