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FDA Issues Multiple Warnings Over OTC Asthma Inhaler, Bentonite Me Baby Clay Product, and MRI Imaging Specialist Located in Georgia

Mar 30, 2016

Inspectors from the U.S. Food and Drug Administration (FDA) recently released warnings concerning severe risks associated with an over-the-counter (OTC) asthma medication, a skin and hair product, and a mammography clinic.

An OTC asthma drug was described as "Possibly Fatal," according to the FDA in its strongest warning letter issued to Dr. Natural Healing in Delaware. The firm sells OTC bronchodilators in drug stores. Law360 indicated that the FDA's letter redacted the product name; however, Dr. Natural's website advertises inhalers with powder capsules under the name "Prime Asthma Relief." Epinephrine powder capsules are used in the Dr. Natural Healing inhalers, and the FDA indicated that the combined formulation and usage is not recognized as safe and efficacious and also indicated its concerns of inaccurate dosing. Too low of a dose may result in an improperly treated asthma attack and too high may lead to cardiovascular issues due to epinephrine's stimulating effects, according to the letter. The FDA indicated, among other things, that too high or too low of a dose may lead to "serious and possibly fatal adverse outcomes."

The agency also issued a warning letter concerning lead contamination in "Bentonite Me Baby," which is touted for skin and hair care and marketed by Florida-based Alikay Naturals. Law360 reported that the product has been sold by national retailers such as Target Corp. and Inc. The letter followed a January safety alert issued by the FDA over problems including that "Bentonite Me Baby" contains lead and could cause kidney damage, as well as damage to the immune and central nervous systems. The FDA indicated that "Bentonite Me Baby" contained lead levels of 37.5 parts per million (ppm). While there are no set limits for lead in cosmetics, lead levels in candy, set by the FDA, are a significantly lower 0.1-ppm.

The agency also indicated that its ongoing discipline involves "Bentonite Me Baby" being marketed as a drug, not a cosmetic, noting that the product's labeling includes treatment of inflammation and eczema and its purported ability to "remove harmful toxins from the body," thereby increasing energy. The FDA also wrote that "Bentonite Me Baby" was a "misbranded" drug as its labeling did not contain sufficient instructions, only instructions to "do research or consult a professional" before using "Bentonite Me Baby" internally. There is no label information on proper frequency and duration of use, added Law360.

The FDA also published a warning letter alleging violations of the Mammography Quality Standards Act (MQSA) of 1992 by Georgia clinic, MRI Imaging Specialist. This was the first FDA warning letter of its kind focused on MQSA violations since December 2014 and followed a February inspection and two prior inspections in 2014 and 2015 that revealed violations, indicated Law360. "The continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility," the FDA wrote, threatening daily penalties of $11,000, as well as the clinic's MQSA certification being revoked if the problems are not rectified. Under federal law, MQSA certification is mandatory to the clinic's operation.

The FDA cited eight violation types, including a "Level 1" violation that constitutes a serious risk to patients under the MQSA and concerned an alleged failure to create a system for promptly providing patients with exam results. Seven issues were deemed "Level 2," moderately serious risks, over failure to enter all positive mammograms into a tracking system and failure to conduct quality assurance by following up with patients to determine the accuracy of positive mammograms.

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