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Non-Compliance with FDA Labeling Requirements Leads to Numerous Recalls

Recalls require products to be removed from the market until the issue in question is resolved. Companies can initiate a recall themselves, but the U.S. Food and Drug Administration (FDA) can also request or order a recall. This situation can be a financial burden for a company. Products being off the market can lead to a loss of potential sales, and it takes time and money to fix the necessary problems.

In recall cases involving food the losses can be even greater. The FDA Food Safety Modernization Act (FSMA) authorizes FDA to order mandatory recalls of articles of food if the responsible party fails to voluntarily conduct a recall. FSMA also authorizes FDA to collect fees for non-compliance with food and feed recall orders. Non-compliance with a recall order includes not initiating an FDA ordered recall, not conducting the recall in the manner specified by FDA, and not providing FDA with requested information regarding the recall.

In July 2014 alone there were 143 recalls due to labeling issues, 94 of which were food products. The labeling issues included improper claims, such as claiming to be organic, and missing or incorrect required information like instructions, ingredients, and expiration dates. FDA label requirements can be complicated. Registrar Corp can revise your food, drug, medical device or cosmetic label to comply with U.S. FDA regulations.

Registrar Corp is an FDA consulting firm that helps companies with U.S. FDA regulations. If you have questions about FDA label requirements or any other FDA regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.





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