The Food and Drug Administration last week shut shut down several Colorado dietary-supplement companies that it said were selling “misbranded and adulterated” products that wrongly purported to treat “high cholesterol, hypertension, diabetes, depression and muscle pain.”
The agency said violations such as these “put consumers’ health in jeopardy.”
If President Trump has his way with the federal budget, it’s almost a sure thing that people increasingly will be at greater risk when it comes to the safety and effectiveness of over-the-counter supplements.
There would be a lot of damage if Trump’s budget were enacted, with massive cuts to the Environmental Protection Agency, the Labor Department and the U.S. Department of Agriculture, among others, and elimination of entire programs, such as the National Endowment for the Arts.
The final budget approved by Congress undoubtedly will be more level-headed. But the White House’s opening salvo reveals Trump’s priorities.
Potential cutbacks at the FDA underline the stakes for consumers.
There’s no word yet on the agency’s funding under Trump. But the FDA’s bureaucratic parent, the Department of Health and Human Services, would see its overall budget cut by 18% under Trump’s financial plan, or a loss of about $15 billion from current funding levels.
Now consider the FDA’s Office of Dietary Supplements. It has a budget this year of less than $5 million and fewer than two dozen staffers overseeing a $37-billion industry.
It’s a sure bet the office’s budget won’t get any larger under Trump. More likely it will have to get by on even less cash and may have to reduce the number of people charged with ensuring that pills and powders sold to consumers as health enhancers aren’t snake oil.
Lyndsay Meyer, an FDA spokeswoman, remained stoic in the face of looming budget cuts. “We do the best with what we are given,” she told me.
The Colorado supplement makers that were shuttered last week — EonNutra, CDSM and HABW — might seem like a regulatory win except for the FDA’s admission that it had been after the companies’ owner, Michael Floren, since 2012, and that it had visited his offices four times over the last five years.
Each time, the agency said, Floren promised he’d clean up his act, and each time he “failed to make the necessary corrections.”
The fact that a business owner could keep violating federal rules, and keep selling questionable products to consumers, speaks volumes about the freewheeling nature of the supplements industry. The simple fact is that much of the industry’s activities fall under the honor system.
That’s because of a 1994 law, the Dietary Supplement Health and Education Act, that defined supplements as a food rather than a drug and gave the industry considerable latitude in its messaging to consumers.
Supplement companies will tell you all’s well. “There’s more than enough regulatory teeth,” said Dan Fabricant, executive director of the Natural Products Assn., a trade group.
Prescription drugs can’t be sold to consumers until ample evidence is provided to the FDA that the med is safe and effective. A drug that purports to cure insomnia, say, would need to be backed up by clinical trials and documentation.
On the other hand, a supplement that claims to help people sleep — but, importantly, doesn’t claim to cure a disease — requires no such proof.
The FDA only wants to see a statement addressing the supplement’s intended use and a pledge from the company that it has “substantiation that the statement is truthful and not misleading.”
Substantiation? Is that like scientific evidence? Not so much.
The FDA’s Meyer acknowledged that substantiation for supplement claims might be nothing more than a website that came up in a Google search.
Moreover, she said the agency lacks the authority to require that a supplement maker reveal its substantiation. If the company says “bug off,” the FDA has no power to insist.
“We have to follow the law,” Meyer said. “There’s nothing that says the substantiation must be provided to the agency.”
This is nuts. I’m not saying that supplements should be regulated as strictly as prescription drugs. But it seems obvious that the bar is set way too low for an industry that promotes “self care” of people’s health.
Granted, many popular dietary supplements are uncontroversial. “Multivitamins, fish oil, Vitamin D — this industry is rather boring,” said Fabricant at the Natural Products Assn.
I take melatonin when I go through bouts of sleeplessness or when I travel to different time zones. It seems to work and there’s been enough research into the hormone to attest to its relative safety. The most common side effects, according to the Mayo Clinic, are daytime sleepiness, headaches and dizziness.
Not all supplements are as benign. Case in point, ephedra, which was used in pills that purported to boost energy or reduce fat.
It was banned by the FDA in 2004 after being linked to heart attacks, strokes and deaths. Yet ephedra extracts that weren’t included in the agency’s ban are still available online as a performance enhancer for athletes.
More often than not, a supplement will be little more than a placebo, according to researchers. An editorial published in the Journal of the American Medical Assn. in October said that “for the majority of adults, supplements likely provide little, if any, benefit.”
Nevertheless, millions of people use supplements on a regular basis, and they’re easily purchased at pharmacies, supermarkets and specialty stores.
At the very least, supplement makers, or their trade associations, should be required to conduct controlled trials supporting claims about a product’s usefulness. Simply saying you have “substantiation,” and not even having to reveal it, is a laughably weak public safeguard.
Nearly 20 million Americans take omega-3 fish oil supplements to fight heart disease. The American Heart Assn. issued an advisory last week concluding that the supplements “may slightly lower the risk of dying after heart failure or a recent heart attack, but they don’t prevent heart disease.”
I looked online. I found plenty of substantiation for fish oil giving you a healthier heart.
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