Who regulates vitamin patches anyway?
In the United States, dietary supplements are regulated by the Food and Drug Administration (FDA) as food, not drugs, but the Dietary Supplement Health and Education Act of 1994 (DSHEA) made it possible for supplement companies to bring their products to the market without FDA review. Instead, manufacturers themselves are responsible for ensuring their products are safe and accurately labeled. Once a supplement is on the market, the FDA can inspect manufacturing facilities and ensure products are being correctly labeled. This includes the large market of oral capsules, as well as things like gummies, powders, bars, and liquids. But do you know what isn’t regulated as a dietary supplement? Transdermal patches. “A dietary supplement must be intended for ingestion,” an FDA spokesperson explained over an email exchange. “Because of this, transdermal patches cannot be dietary supplements and, therefore, are not regulated as supplements. The FDA is aware that some transdermal vitamin patches are being falsely marketed as dietary supplements; the agency considers this action to be health fraud. Generally, the FDA considers any patch product that is promoted as a dietary supplement with claims to affect the structure or function of the body to be an unapproved new drug.” In other words, the FDA does not consider vitamin patches to be supplements—which is why they don’t regulate them that way. If a vitamin patch is marketed with claims about a product’s ability to diagnose, cure, mitigate, treat, or prevent diseases or conditions, then it would technically be considered an unapproved drug. Some patch companies market their products by simply listing the ingredients—this is typically considered okay, depending on the intended use. On its site, the FDA gives an example of essential oils: Totally fine to say they’ll make you smell good, but calling them a form of aromatherapy that can help you sleep better qualifies them as a drug. So when patch companies claim that their products boost energy or help you sleep, for instance, they are sliding into unapproved new drug territory and could be inspected by the FDA as drugs.
Has any research been done on vitamin patches?
In 2019, board-certified general surgeon Shireesh Saurabh, MD, published a retrospective chart review comparing bariatric surgery patients who used a multivitamin patch versus those who took an oral multivitamin. His trial found patients who used a vitamin patch were more likely to be deficient in vitamin D and had lower serum concentrations of B1, B12, folate, and ferritin. Given his findings, today he only recommends oral supplements for his patients. When I reached out and asked about the vitamin patches branded for wellness, he points out, “Most of the patches in the market do not have any data/study information on their website which can back their claim.” The trials we do have on transdermal vitamin patches are small and unblinded, a research approach where both the researchers and the participants are aware of the treatment or intervention being administered. An unblinded study is considered less reliable than a blinded study because the level of awareness regarding what’s being studied can introduce bias and influence both the participants’ and researchers’ perceptions and outcomes. Until these patches can be tested in larger populations, in a more controlled environment, it’s hard to tell just how meaningful the results are.
So… do vitamin patches work?
Every doctor and pharmacist I spoke to for this story agreed that, while vitamin patches have the potential to work in some scenarios, we simply don’t have the data to prove they are an effective route to getting the nutrients our bodies need. “The thing with transdermal patches is that we just don’t have the same amount of data in terms of studies [being] done on them as compared with oral supplementation,” says Fatima Stanford, MD, MPH, MPA, a physician at Massachusetts General Hospital and recent appointee by Biden to the Dietary Guidelines Advisory Committee, which provides evidence-based recommendations to inform the development of dietary guidelines for Americans by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA). Dr. Standford does not use transdermal vitamin patches with her patients. What is already well-understood? Nutrient absorption through the GI system. This is why one pharmacist I spoke with told me they lean toward recommending oral supplementation, whether that be gummies, capsules, or tablets. Our skin works as a barrier, keeping foreign things from entering our bodies. However, there are FDA-approved drugs in patch form—think nicotine, scopolamine (used to prevent motion sickness), hormones (birth control), etc.—that are capable of penetrating the skin barrier. What’s more, Dr. Stanford also points out that most people don’t need supplementation in the first place, since we get the majority of our nutrients from the foods we eat. “Before deciding to go to your favorite pharmacy or Amazon or wherever you go to buy your vitamins, first, check and see if you really need it,” she says. If you suspect you may be deficient in vitamins, the best approach is to consult a doctor. They can assess your symptoms and medical history, and possibly order blood tests to determine your vitamin levels accurately. Self-diagnosing deficiencies can be unreliable, so it’s important to seek professional guidance for an accurate assessment and appropriate recommendations. So while the hype around vitamin patches does make them sound appealing (I’ve tried more than a few billed as being able to boost your energy) and I do love self-diagnosing, I’m going to save the money I’d spend on them for Starbucks instead, a tried and true way to energize myself.