FDA Points to OTC Drug Dangers Due to Lead Contamination

According to Law360, the U.S. Food and Drug Administration (FDA) warns of severe risks posed by the following: an over-the-counter asthma drug; possible lead contamination in a popular skin product; and imaging violations in a mammography clinic.

The FDA cited Dr. Natural Healing, based in Delaware, who sells bronchodilators over the counter in drugstores. These inhalers, under the name Prime Asthma Relief, use epinephrine powder capsules that the FDA says are not recognized as safe and effective. The concern is the possibility of inaccurate dosing. If dosing is too low, an asthma attack may not be dealt with properly. If dosing is too high, cardiovascular problems may occur from the stimulating effect of epinephrine. In either case, “serious and possibly fatal outcomes” could result, the FDA said.

The next item to be flagged is a clay skin and hair care product suspected of lead contamination. It is sold by Bentonite Me Baby (BMB), and available nationally at Target Corp. and Amazon.com, Inc. A letter from the FDA alleged that BMB contained lead and carried various risks such as damage to the kidneys, central nervous system, and immune system.

The FDA found 37.5 parts per million of lead levels in the clay product. Although there are no exact lead limits in cosmetics, as a comparison, lead levels in candy have a limit of 0.1 parts per million. The FDA also alleged “misbranding” of the product as the BMB label included statements about treatment of inflammation and eczema as well as an alleged ability to “remove harmful toxins from the body.”

A warning letter from the FDA relating to an MRI Imaging Specialist clinic in Georgia alleged violations of the Mammography Quality Standards Act following a February 2016 inspection. Two previous inspections had revealed violations in 2014 and 2015. The FDA threatened penalties of $11,000 per day and revocation of the clinic’s certification if the problems were not fixed.  The FDA cited eight types of violations, including one “Level 1” violation alleging that patients were not promptly given exam results constituting a serious risk. The other seven violations were “Level 2” representing moderately serious risks.

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