FDA’s ‘abundance of caution’ should extend to supplements
By SARAH GREEN CARMICHAEL | Bloomberg Opinion | Published: May 4, 2021
It’s a weird system when an effective vaccine was suspended during a deadly pandemic for a maybe-one-in-a-million chance of blood clots, but you can get free two-day shipping on an elixir of elk antler velvet.
The U.S. Food and Drug Administration is known for being cautious — in the case of the Johnson & Johnson COVID-19 vaccine, the watchwords were “abundance of caution.” I can’t help but think: I sure wish these folks were more risk-averse when it comes to the supplements in my medicine cabinet.
Supplements — vitamins, hormones, herbs, enzymes and probiotics — are only lightly regulated, and the existing rules are poorly enforced. The pandemic underlines why this is not a good thing.
Snake oil salesmen have always taken advantage of uncertain times to peddle their concoctions: The Center for Science in the Public Interest found 46 supplements on Amazon improperly touting antiviral powers.
Many consumers assume the FDA tests supplements before they can be sold, but that’s not so. The FDA does not review products like melatonin or magnesium before they hit the market; they can only tell supplement-makers to recall their products if it turns out they cause harm.
The system for reporting side effects is haphazard. Supplement-makers are supposed to provide safety data to regulators on “new ingredients” — those that didn’t exist before 1994 — but this system is full of loopholes. The bottom line: supplements are assumed to be safe until proven otherwise, which we only find out after they’ve hit store shelves.
“It’s like a faith-based system,” says Dr. Pieter Cohen, an associate professor at Harvard Medical School. That might work for consumer goods like, say, mattresses. But “it’s really a problem if you’re selling pills,” Cohen said.
The laws are lax because of a bipartisan bit of 1994 legislation, the Dietary Supplement Health and Education Act, which mostly allows companies to regulate themselves. Supplement-makers heavily favored the law, and no wonder. In the years after its passage, the number of supplements on the market skyrocketed. Between 1994 and 2019, the market quadrupled from $4 billion to $40 billion. The surge in CBD products is expected to keep this growth going.
Despite this booming business, many experts say supplements are essentially useless. In the memorable wording of my high school biology teacher, our bodies don’t absorb the extra nutrients and we end up with “very expensive pee.”
But useless doesn’t mean innocuous. In a Pew poll, one in eight Americans said they or someone they knew had suffered serious side effects from taking a supplement. And multiple studies have shown that supplements are often contaminated or mislabeled. One 2013 study tested 44 herbal supplements from 12 companies, and found that a significant number contained no trace of the plant they advertised. Many also included substances not listed on the label. Just two of the 12 brands tested contained only what they said they did.
More recent studies have found supplements containing unsafe levels of arsenic, lead, mercury, toxic fungi or salmonella. Some contained anabolic steroids or prescription drugs. Some supplements have caused liver damage or even death.
“The FDA does a certain number of inspections of supplement firms every year, and time and again we see they’re not in compliance” says Cohen. “There are basic manufacturing problems.” The worst offenders are complex compounds of different substances — the products often touting improved athletic performance, sexual performance or weight loss.
Basic herbal supplements — such as echinacea or St. John’s Wort — can also have issues. Reviews by outside scientists have found that the former is sometimes not echinacea at all, but a different plant “linked to rashes, nausea and flatulence,” while the latter was sometimes Alexandrian senna — a “powerful laxative.”
Cohen says vitamins suffer fewer problems. But at the same time, many doctors tell patients to take them, which raises the stakes. Calcium is urged on older women, iron on anemics, Vitamin D on people suffering from dark Northern winters, and folic acid on people planning to get pregnant. In such cases, you really want to be sure what you’re putting in your body is both safe and effective.
It’s up to the consumer to figure which vitamins might be worth the money. Gummies are popular but essentially useless. “Everyone loves them, because they’re basically candy,” writes Dr. Monique Tello of Massachusetts General Hospital. “I do not recommend gummy vitamins for anyone.”
When my doctor recommended I start taking vitamins, I picked bottles off the shelf using the same approach I take to wine-buying: Does it have a nice label? Is it a little bit expensive, but not the most expensive? This method worked about as well as it does with wine, which is to say, not very well at all.
It’s not that there’s no regulation of supplements, Cohen says. But the rules just don’t match the complexity of the products involved. “We need to make some changes to the law so the regulations can ensure the safety of these health products,” he said. “And I say this as a physician who recommends supplements every single day.”
I understand the FDA has more important things to do right now. But the COVID-19 pandemic has only reminded us that we need to know what we’re putting in our bodies is safe. Consumers often think of supplements as “natural” or “safer” than traditional pharmaceuticals, but that’s not necessarily the case. We could do a lot worse than to unleash the full force of the FDA’s caution on this $40 billion-a-year industry.
Sarah Green Carmichael is an editor with Bloomberg Opinion. She was previously managing editor of ideas and commentary at Barron’s, and an executive editor at Harvard Business Review, where she hosted the HBR Ideacast.