FDA Warns Possible Lead Contamination from OTC Drug


The U.S. Food and Drug Administration (FDA) issued letters of warning involving an over-the-counter asthma drug, a skin and hair product, and a mammography clinic.

Dr. Natural Healing, seller of bronchodilators containing epinephrine powder capsules, received one of the strongest warning letters from the FDA, claiming the combined formulation and usage of its product is not recognized as safe and effective. The concern is with the accuracy of the dosage. Too little, it may be ineffective. Too high, cardiovascular problems may occur due to the stimulating effects of epinephrine, according to Law360. In either case, “serious and possibly fatal” outcomes could result, said the FDA.

Another warning letter went to Bentonite Me Baby (BMB), a clay product for skin and hair care. A Florida-based company, Alikay Naturals, markets the product that is available nationally at Target Corp. and Amazon.com, Inc. The FDA letter alleged that BMB contained lead and thereby posed a variety of dangers such as damage to the kidneys, immune system, and central nervous system, reports Law360.

BMB has technically been marketed as a drug, as opposed to a cosmetic, and carries a label alleging it treats of inflammation and eczema, as well as the ability to “remove harmful toxins from the body.” This caused the FDA to view the BMB as a “misbranded” drug, citing a lack of adequate information and instruction for proper use.

A Georgia clinic, MRI Imaging Specialist, has received a warning letter from the FDA alleging violations of the Mammography Quality Standards Act of 1992. This was on the heels of two previous inspections in 2014 and 2015 that had revealed violations that were not corrected. The FDA threatened penalties of $11,000 per day and revocation of the facility’s certification if the problems were not fixed. The “Level 1” violation posing a serious risk to patients was a failure to promptly provide exam results. The other seven violations were “Level 2” indicating moderately serious risks.