Topical Product Claims Turn Magnesium Oil Into Drug
All marketing is “labeling”
FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was an analgesic drug.
Here are some of the cited claims from the warning letter.
“For muscle cramps or pains, spray directly on problem area.”
“Designed to provide relief from body tension and soreness.”
“Leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.”
FDA classified this as a “topical external analgesic (OTC) drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h,” which is allowed if the product is made using a specific OTC monograph (recipe) under applicable GMPs. Since the product did not follow the monograph, primarily because other “active” ingredients like MSM are not on the monograph, FDA deemed this product an unapproved new drug.
To be fair, the other sections of the warning letter contain very serious disease claims like “cancer” and “depression,” which are likely the primary reason reasons for the letter. Some warning letters like this are very comprehensive and may cite “secondary” claims, which may not be enough to trigger a letter on its own. In the case of the magnesium oil, I doubt making claims about pain or soreness is enough for agency action, but listing diseases related to magnesium deficiency, such as insomnia, and then suggesting the product can address these deficiencies is high risk. I have seen some companies use the nutrient deficiency and disease claim strategy on dietary supplements, which is out of my risk tolerance, but when used on topical products that do not provide absorbable nutrients, it goes too far.
As a friendly reminder, topical non-drug products are not allowed to “affect the structure or any function of the body,” which supplements are permitted to do.
So would a topical product with a “relieve and soothe” claim attract a warning letter? This is unlikely unless there were adjacent claims like “helps with arthritis,” which turned the product into a drug.
Read the full warning letter here.
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.