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 potential 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.

"I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks," Gottlieb says.

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.

Five Supplements You May Need


While a lot of supplements are falsely advertised or, more likely, simply not needed, there are some that medical professionals agree are worth asking your doctor about. Here are five supplements that may be needed to meet the increased nutrient needs of older adults.
  1. Vitamin D. The use of sunscreen prevents many adults from absorbing the vitamin D they need from the sun. Try exposing arms and legs to sun for a limited time daily to increase your levels. Older adults who don’t spend much time outside or whose bodies don’t absorb vitamin D well may need extra, according to Dr. Nothelle.
  2.  
  3. Calcium. While older adults often need extra calcium, the caveat is that this supplement increases the risk of a heart attack. And calcium doesn’t have to come in a pill or gummy. “Eating plenty of dairy, canned fish with soft bones, and dark, leafy greens like kale may be a safer option,” Dr. Nothelle says.
  4.  
  5. Vitamin B12. “Vitamin B12 needs acid from the stomach to be properly absorbed,” Dr. Nothelle reports. Some older adults might not produce adequate acid, or it can be inhibited by acid reflux medication like Prilosec or blood sugar drugs such as metformin. Ask your doctor to test for adequate B12 in your blood.
  6.  
  7. Vitamin B6. This helps protect nerves and form red blood cells. You can boost Vitamin B6 by eating potatoes, bananas and chicken. 
  8.  
  9. Acetyl-L-Carnitine (ALCAR). Some studies connect ALCAR with the body’s ability to ward off age-related fatigue and cognitive decline. It may be helpful for older adults with mild cognition impairment or Alzheimer’s, according to a study from the NIH Office of Dietary Supplements. 
"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.

Sandra Eskin, food safety project director for the Pew Charitable Trusts, says that the new plan is a good start, but much more needs to be done.

"This is a great first step to improving the safety of dietary supplements," she said. "In recent years, there’s been an explosion of products with risky ingredients, and we think it's absolutely critical that the agency address this problem.”

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.

The FDA welcomes feedback from consumers while seeking to balance access to lawful supplements and protect the public from unscrupulous marketing. Anyone can submit feedback to support or refute the FDA’s preliminary drug assessments by sending an email to odsp@fda.hhs.gov.

Should You Take Supplements?


Alcohol and Supplements Don’t Mix


Beware of taking supplements and drinking alcohol. Just like combining supplements with prescription drugs, there may be unintended consequences that can be dangerous or even fatal.

For instance, alcohol combined with aspirin can increase the risk of intestinal bleeding. Cold and allergy medicines containing antihistamines mixed with alcohol can make you exceptionally sleepy. Alcohol and acetaminophen may cause irreversible liver damage. Sleeping pills, pain pills or anxiety or anti-depression medication can be deadly when combined with alcohol.

Your friends routinely recommend this supplement or that herbal remedy, swearing that it’s helped whatever the current concern may be. But 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.”

Sources:

https://www.cnbc.com/2019/02/11/fda-plans-to-strengthen-regulation-of-dietary-supplements-create-rapid-response-tool.html
https://www.healio.com/family-medicine/pharmacology/news/online/%7Baef542ba-ff12-40a7-a4bf-7313bfcccbb1%7D/fda-proposes-overhaul-of-dietary-supplement-industry
https://www.usatoday.com/story/money/2019/02/11/dietary-supplements-grow-safer-first-fda-overhaul-25-years/2835763002/
https://www.fda.gov/newsevents/newsroom/pressannouncements/default.htm
https://www.silversneakers.com/blog/supplements-older-adults-need-know/
https://www.livestrong.com/article/375909-what-are-the-effects-of-alcohol-in-vitamins-minerals/
https://www.nia.nih.gov/health/alcohol-and-medicines?utm_source=NIA+Main&utm_campaign=2c2547dee4-20190401_alcohol&utm_medium=email&utm_term=0_ffe42fdac3-2c2547dee4-7425877



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