Foodborne illnesses claim the lives of nearly 3,000 people each year. Another one in six, or 48 million people, get sick and 128,000 of them are hospitalized. The numbers are high and the dangers are real. This is why the U.S. Food and Drug Administration (FDA) is empowered, by way of strict regulations and a watchful eye, to help protect consumer safety. Companies failing to adhere to FDA’s rules and regulations are subject to serious penalties. Make sure your company is prepared and ready to comply, which all begins with understanding and following the proper submission protocol.
What Is FDA Compliance For Food Contact?
Product developers seeking approval for a new food contact substance (FCS) are required to submit a food contact notification (FCN) to the Office of Food Additive Safety (OFAS) at least 120 days prior to the marketing of the FCS. The submission of the FCN must contain sufficient information to demonstrate that the item is safe for the intended use stated in the notification. Safe for the intended use is the key phrase, as some companies take liberties with FDA’s wording.
FDA Compliance Controversy
FDA keeps a close watch over food contact substances for consumers, who may not be aware of the potential dangers that come with food contact substance, including the migration of materials into food. FDA experts—toxicologists, endocrinologists, chemists and epidemiologists—have determined a fine line for safety, which is mapped out by the Code of Federal Regulations Title 21. Companies large and small often fudge the line, citing rule 21 CFR 170.39, better known as the “housewares exemption.”
The housewares exemption means the product does not have to go through review because the company’s submission relies on the product’s intended use to guarantee its safety. Controversy arises when plastic materials are supposed to be used one way, yet are regularly used another. For example, colored plastic utensils, plates and cups are a great way to get ready for a party. You can serve a large group, then throw the plastics away and never worry about dishes. That’s the way the products are supposed to be used. But plenty of people wash the items and reuse them. This form of recycling may not be the use reported to FDA. In fact, many manufacturing companies never mention washing and reusing their products on their website at all, despite knowing that the practice commonly occurs. The result is that potential safety questions about long-term use are not addressed. This also opens up the issue of whether the manufacturer used the housewares exemption as a legal loophole.
Facing the Penalties
Packaging is designed to protect. Utensils, plates and cups are created as a sanitary solution for eating and drinking. But when public safety is called into question, FDA will invoke its power, as given by Congress, to protect consumers from unsafe food. FDA usually starts with a written warning. Failure to comply means you could be penalized with a recall, product seizure, suspension of registration, administrative detention or even prosecution. So be sure what you list in your initial notification and the required proof of safe use match up to the product’s actual use. This goes for self-submitting for FDA approval and the housewares exemption.
If you need assistance verifying that your product is safe and you are providing all the proper notification for FDA compliance, contact a food regulatory service attorney. Reaching out for a full evaluation is a great way to double check before submission—and you avoid becoming part of an FDA compliance controversy.
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