Take a walk down the vitamin aisle at your local pharmacy and if you read a few of the bottles, you might suddenly find yourself wanting what’s promised – more energy, improved performance, healthier hair and nails — the claims are endless.
Who wouldn’t want those things delivered in a reasonably priced bottle that can be purchased right off the shelf?
But do the supplements really help? More importantly, is what’s on the label actually in the bottle? Is there any way to know if the pills work?
The Food and Drug Administration does not monitor supplements as it does prescription drugs. For a medication to be sold in the United States, it has to be FDA-approved, with trials to show it’s safe and does what it’s made for. There is a cost to FDA approval and each application costs thousands of dollars.
Every approved medication is produced to meet quality standards and every dispensation of the product is tracked with lot numbers. If there is a problem with a particular batch of drugs, they are recalled, and the patients affected are identified by pharmacies and notified about the glitch. Constant monitoring for quality assurance is required by the FDA.
As for supplements, most have a disclaimer that states the product is not meant to diagnose, treat, cure or prevent disease. And there is no certainty that what is stated on the label truly represents what is inside the bottle, in the amount specified, or that it accomplishes what it claims.
Thus far arguments have centered around the FDA not having the time to review each and every supplement without taking up precious time better spent on evaluating actual prescription drugs. After all, the time it takes from discovery to market can be longer than a decade. Last year “compassionate use” and “right to try” legislative efforts highlighted the need to allow patients who might not have long to live the right to use medications still under the review process.
What if there were a subsection of the FDA funded by the $40 billion supplement industry that would provide quality oversight of the products currently on the market? This could be done in two phases.
The first step would be at least monitoring the labelling of supplements and testing to ensure they contain the ingredients they list on the packaging. The Journal of the American Medical Association reported last fall that in a study of supplements from 2007 to 2016, almost 800 products were found to contain unapproved ingredients. In some cases, toxic ingredients, such as what was seen with OxyElite in Hawaii just a few years back.
The second phase should be an industry-funded series of clinical trials to provide some proof of the claims made by the supplement companies. The rigorous types of trials required for prescribed medications are best, but may not be possible in the supplement industry. Rather, alternative clinical observation trials can be done, or some other clinically validated substitute so that there is a scientific basis upon which people can decide if the supplement they are considering is right for them.
What if there were a subsection of the FDA funded by the $40 billion supplement industry that would provide quality oversight of the products currently on the market?
Although more energy might be a subjective response to certain ingredients, if 80 percent of people felt that when taking a product, there is at least a chance that it might work.
The FDA has recently gone after claims made by supplement-makers that are touted to treat Alzheimer’s dementia and posted information for the general public on their website. However, this is only after versions of the product were sold by different companies.
The only reason the FDA has declared the products unsafe is because of the claims to treat and cure a disease. This does not include an actual evaluation of the ingredients or any trials of the products themselves.
Rather than this retroactive approach, having a supplement approval process would save potential consumers thousands of dollars.
Creating such a system does not have to limit the usual operations of the FDA and would be funded by the very industry that is making billions of dollars on the products they sell to consumers. The additional cost for this can be mitigated by having an official certification process that reassures users that the product meets more rigorous standards than before.
That’s worth the extra dollars, particularly if certification becomes an expectation.
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Kathleen Kozak, M.D., is an internal medicine physician at Straub Clinic and Hospital. She is also a part-time medical director for UHA Health Insurance and is the host of “The Body Show” on Hawaii Public Radio.