Just last month Registrar Corp blogged about how labeling errors were one of the most common violations of FDA regulations. A concrete example is in the headlines, as popular baby food manufacturer Gerber is being sued for inappropriate claims in its advertisements. The U.S. Food and Drug Administration (FDA) considers advertisements to be an extension of labeling; therefore, advertisements must follow FDA labeling regulations. FDA has strict regulations regarding health claims made about food and beverages. Food manufacturers must obtain authorization from FDA before including health claims on their product labels.
Though advertisements must adhere to FDA regulations, non-compliance issues dealing with advertising are handled by the Federal Trade Commission (FTC). FTC is suing Gerber for advertising that one of its baby formulas could prevent or reduce the risk of allergy development, as well as for advertising that the claim is approved by FDA. According to FTC, Gerber has no scientific evidence to support its allergy-prevention claims. As for the claim being approved by FDA, Gerber received permission from FDA in 2009 to state that the formula may reduce one specific allergy, but only if Gerber clearly stated that there was little scientific evidence to support the relationship. Gerber, however, did not follow either of FDA’s guidelines. The company placed a gold sticker on some of its ads saying “1st and Only: Meets FDA Qualified Health Claims,” leaving consumers to potentially believe that Gerber’s formula was likely to reduce or prevent all allergies. FTC wants Gerber to pull its claims from its labels and advertisements, and may also request of the court that Gerber be required to issue refunds for the formula sold since 2011.
Along with advertising, FDA considers labeling to include all written, printed, or graphic matter accompanying a product, including instruction manuals, websites, posters, and more. FDA labeling requirements are detailed and extensive, so it’s always a good idea to have your product’s labeling reviewed by someone familiar with the regulations. Registrar Corp’s Regulatory Specialists have extensive experience with FDA labeling regulations. Registrar Corp offers a Label Review Service through which Regulatory Specialists will cross reference a company’s product label against thousands of pages within the Code of Federal Regulations, as well as FDA guidance documents, warning letters, and other references.
If you have any questions regarding FDA labeling regulations or would to request a label review, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at: Http://www.registrarcorp.com/LiveHelp