June 8th, 2016 By Virtual Paralegal Services

Here’s what you need to know.

What is Product Label Review?

Product label review is the process of reviewing product labels for compliance with all applicable local, state, federal, international and/or other regulatory guidelines.  Examples of products that this may include are human food, nutritional supplements, drugs, animal feed, cosmetics and medical devices.  To ensure their product labels are in compliance with applicable regulations, large companies may have trained regulatory professionals on staff and smaller companies may rely on outside label review services.  However, many times companies fail to obtain the appropriate level of review for various reasons that include time and cost.

Who Monitors Product Labels?

There are many regulatory agencies that monitor product labels.  Which agency governs depends on various elements such as the product type, intended use, distribution area and many others.  The state provides regulatory oversight of product labels for meat and agricultural commodities such as eggs, milk, grains; processed human food and nutritional supplements; and animal feed and nutritional supplements including pet food and treats.  However, as soon as these products are presented for interstate commerce, they fall under the jurisdiction of federal agency oversight.  The United States Department of Agriculture (USDA) oversees meat and raw agricultural commodities, and the United States Food and Drug Administration (FDA) oversees processed human food, animal feed, human and animal drugs and supplements, cosmetics, and medical devices.  In some cases, there are national trade-organizations that have a form of regulatory oversight.  Additionally, if these products are offered for international sale, there is a regulatory body that is responsible for ensuring products entering the country are labeled correctly.  Although limited, there are even some instances where local government has regulatory oversight over product labeling.  One example would be farmer’s market-type products.

At the state level, regulatory authority and requirements are written into state statutes and administrative code per product type.  At the federal level, regulatory authority and requirements are written into the Code of Federal Regulations as well as supplemental laws.  The majority of products regulated by the FDA are required to be labeled according to the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labeling Act.  Depending on the product type, manufacturers may be required to be licensed at the state and/or federal level and to obtain pre-sale approval for all product labeling.

If the product is offered for sale internationally, the manufacturing facility will be required to register the product in that country and obtain a certificate of free sale for each shipment. The product label must be compliant with all applicable state, federal and international regulations.

Why is Label Review So Important?

Printing product labels is often very expensive.  For example, think of animal feed products where the label is printed directly on multi-layered, colorful, 50 pound bags, or cosmetic products with eye-catching, foil labels.  If a product label is found to be out of compliance on either the state, federal, or international level, it could be placed under stop sale, restricting the product from being further distributed. This can cost a company thousands of dollars before they are able to resume distribution of their product.  This demonstrates the importance of label review before distribution and often times periodically after the product has been established.

For cost effective and reliable product label review services, please contact Virtual Paralegal Services.  Our label review professionals have broad experience across a range of industries to help ensure you are compliant.

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