The Food and Drug Administration (FDA) maintains and regularly updates a complex set of guidelines to ensure that food and other products sold for ingestion or external use on the human body are safe for human consumption. Compliance with the FDA guidelines also helps to ensure that people with allergies or dietary restrictions can easily identify and avoid products which, though generally considered safe, would be harmful or undesirable for people with certain medical conditions or who choose to follow special diets. A summary of the current version of the guidelines appears below. If you still have questions about whether your business is in compliance with current FDA regulations, contact a food safety law attorney.
Food Labeling and Presentation of Nutritional Information
Here are some of the current rules about food labeling and advertising:
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A full list of ingredients should appear on the product’s label
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All claims that a food provides certain health benefits (as identified by a heart symbol) such as “heart healthy” or “low glycemic index” should be supported by FDA-approved research
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Health claims not supported by current FDA research are known as “qualified health claims” and should be accompanied by a disclaimer
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Product labels should contain allergen information, including sources of cross-contamination (such as “processed in a facility that also processes tree nuts”)
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Ingredients should be identified by their common names (for example, “vitamin C” instead of or in addition to “ascorbic acid”)
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The country of origin of food products should be identified on their labels
Facility Registration
Most facilities that manufacture foods, medications, cosmetics, and personal care products must register with the FDA and keep accurate and detailed records of safety practices at the facility. Wholesale and retail distributors of food, pharmaceuticals, and cosmetics must also register. Food production and distribution facilities must renew their registration annually, paying registration fees each year.
Hazard Monitoring, Inspections, and Recalls
Every food production or distribution facility registered with the FDA must document its procedures for preventing contamination and other safety hazards; the written hazard prevention plan must also include strategies for eradicating hazards in the event that they are detected. Facilities must undergo regular inspections and must provide the required documentation to inspectors. Facilities that have handled food products subject to a safety recall must undergo more frequent and more intensive inspections.
Advertising and Marketing
In addition to the product labeling requirements mentioned above, companies that market food products must comply with laws about advertising and marketing. Important factors to consider, with regard to Federal Trade Commission guidelines, include truth in advertising and substantiation of claims. In other words, your marketing promotions should not be misleading, and they should not contain unsubstantiated health claims. If promotional materials include health-related claims not based on FDA-approved research, the advertisement should also contain disclaimers. Be careful not to mislabel or misidentify food products. Likewise, trade dress, packaging, and advertising strategies should comply with current intellectual property laws and should not infringe on trademarks held by other parties.