FDA Overhauls Supplements
For the first time in a quarter-century, the feds are reviewing everything from vitamins to herbal tonics.
Four out of five older consumers take dietary supplements, according to the U.S. Food and Drug Administration (FDA), in spite of the fact that they can interact with commonly prescribed medications. You may not know what is actually in the supplements. Some contain drugs that aren’t listed on the label; others make claims that can’t be substantiated.
Recently, the FDA announced an initiative to inform the public more quickly about potentially illegal or dangerous ingredients, enact updated enforcement strategies and change the way it evaluates products coming on the market. It’s “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” FDA Commissioner Scott Gottlieb says.
Industry Growth Inhibited Regulation
The dietary supplements industry has grown from $4 billion dollars and 4,000 products 25 years ago to a worth of more than $40 billion and at least 50,000 unique items today, according to Gottlieb. These products include vitamins, minerals, and herbs that many older adults consume daily.
The first move from the feds was to mail warning letters to 17 companies selling products that claim to prevent, treat or cure Alzheimer’s disease, diabetes, and cancer. The claims have no basis in fact and carry an additional danger. "Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions," Gottlieb says.
The government has struggled to keep up with the explosion of new ingredients on the market that claim to remedy everything from erectile dysfunction to hair loss. The last major regulation of the industry occurred in 1994 with the Dietary Supplement Health and Education Act. Recognizing that they’d fallen behind, the FDA created the Office of Dietary Supplement Programs three years ago.
New Tool to Alert Public
As part of its new effort, the FDA is launching a tool to make public ingredients that “appear to be unlawfully marketed in dietary supplements.” Dubbed the Dietary Supplement Ingredient Advisory List, it will be located on the FDA website. Consumers can sign up to get the most recent updates.
In a press release, the FDA announced that it had already taken action against eight companies for marketing supplements containing DMHA, which it considers “a new dietary ingredient” for which it hasn’t received notification, or an “unsafe food additive.” The FDA also warned three companies for marketing supplements containing phenibut, which does not meet the statutory definition of a dietary ingredient.
Should You Take Supplements?
What supplements do experts recommend seniors take on a regular basis?
None. Not a single one. Surprised?
“I think supplements are seen by many as only having the potential for benefit, but there is real risk of harm,” according to Dr. Stephanie Nothelle, post-doctoral research fellow in general internal medicine at The Johns Hopkins University School of Medicine. Supplements aren’t regulated the same way as drugs, and you can’t be sure of what’s inside the bottle.
As for vitamins, they’re more readily absorbed from foods than pills. “For a healthy older adult, I do not routinely recommend any supplements,” says Dr. Nothelle, a specialist in the health care of older adults. “The best form of vitamins is from the foods we eat. I recommend that all older adults eat a balanced diet of minimally processed foods.”
The National Institute of Health’s National Institute on Aging concurs. “Most, if not all, of your daily vitamins and minerals should come from food.”
Source: Society for Certified Seniors Blog http://blog.csa.us/2019/06/supplements.html