Does That Label Say What It Should?

The Food and Drug Administration has many tools for the protection of consumers. One of those tools is the requirement that manufacturers submit certain products for testing before making claims about the benefits of those products. When the FDA learns about products on the market that have not been submitted for testing, it often negotiates with the manufacturer on how best to resolve the situation.

Flawless Beauty, LLC, has issued a voluntary recall of 19 products that it sold which the FDA has determined to be “misbranded or unapproved drugs”. These products were sold online through to individuals in countries throughout the world, including the United States.

These misbranded and unapproved drugs have not undergone the thorough testing that other FDA-approved drugs undergo. Therefore, there is no body of research from which to draw conclusions not only about a drug’s efficacy, but also from which to draw conclusions about possible side effects. This presents a dangerous drug to consumers, who rely on a product’s labeling to guide their decision making and to determine whether a product is right for them.

In the case of Flawless Beauty’s 19 products, the manufacturer reported to the FDA that it had received no notification of “adverse events” related to the recall – meaning they were unaware of any harm being caused by the products. Unfortunately, that does not guarantee that an adverse event will not occur.

If you purchased any of the products found here, you should stop using them immediately, and contact the individual listed on the recall notice to determine the process for obtaining a refund. If, however, you used these products and suffered an injury that you believe was caused by the product, the proper authorities must be made aware.

“Flawless Beauty and Skin marketed a product as something that it was not, and for that, they are being encouraged to recall it and reimburse buyers,” said Ben Whitley, a partner with Whitley Law Firm, which deals regularly with dangerous products litigation. “They are taking the right steps, at least initially. But they marketed a product as something it wasn’t. If that product resulted in an injury, the consumer should be able to see justice done, whether through enforcement by the FDA or enforcement through the courts.”

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