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Dietary supplements mistaken for antibiotics
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A recent FDA inspection of Multi-Mex Distributor Inc. revealed that packaging for a dietary supplement mimics an antibiotic readily available in Mexico and likely familiar to Hispanic consumers.
In response to this inspection, the manufacturer announced this week that it is recalling dietary supplements that may be labeled as amoxicillin. The products were distributed in the following states: Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado and Indiana.
Although the labels were printed in English and Spanish, according to FDA’s MedWatch, the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers. It was determined the children had been given a dietary supplement, Amoxilina, which the parents may have believed was the antibiotic amoxicillin.
According to the FDA, warnings of these dietary supplements made news in Texas on April 28, when four children presented to a medical center with worsening illnesses after being given dietary supplements the parents may have believed were antibiotics.
According to a press release from Texas Attorney General Greg Abbott, a temporary restraining order was obtained this week against Georgia-based Multi-Mex Distributions Inc. and Houston-based San Martin Distributing Inc. for unlawfully marketing and dispensing a dietary supplement. According to the state’s enforcement action, Multi-Mex and San Martin targeted Hispanic communities in the marketing of these products.
According to state investigators, the defendants’ Amoxilina labels claim — in both Spanish and English — that the dietary supplement is “without side effects and naturally combats infection.” Multi-Mex also prints a Spanish phrase on the back of the capsule membrane that states “cualidades antibioticas naturales,” which translates to “quality natural antibiotics.” Complaints received by the Texas attorney generals’ office indicated that most of the Spanish-speaking parents purchased the supplement for children with streptococcal pharyngitis or otitis media because they believed that they were buying amoxicillin, which is available over-the-counter in Mexico.
The FDA advises health care professionals to report adverse events, side effects or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and adverse event reporting program at www.fda.gov/MedWatch/report.htm or by calling 1-800-332-1088.
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