Too few food business owners understand the range of commercial risks created by food labeling.

Poorly designed food labels expose food manufacturers to a range of regulatory risks. Products that deviate from regulations in any particular are considered “misbranded”. Misbranded foods subject manufacturers to adverse administrative action, such as voluntary or mandatory recall, administrative detention, or they may receive an official Warning Letter and demand for corrective action by regulators.

A packaged food or beverage product is not market-ready until its labeling has undergone a thorough compliance audit. Compliance is just as important as creating the aesthetically perfect label.

Food and Drug Administration food labeling regulations begin at 21 C.F.R. 101.01, and run on for several hundred pages. Even the FDA’s Guidance for Industry, an excellent and concise resource for food labeling guidance, comes in at 130 pages. Contained within these volumes is everything you need to know about how to name a product, where to place the required objects on the label, how to make structure/function and other claims, and much more.

The typical fiber claim provides the perfect example of how tricky it can be to market a product while navigating these pages and pages of rules. A “high fiber” claim, like any other “high” claim on a food product, can be made when a single serving of food contains more than 20% of the daily recommended amount of a certain ingredient. 21 CFR 101.54(b). However, there is an important requirement for fiber claims that is not required when making many other “high” claims. To find the additional requirement, you’d need to know to read further down in the regulation. If a fiber claim is made and the food is not low in total fat, then the label must disclose the level of total fat per labeled serving. 21 CFR 101.54(d)(1).

Even successful companies, whose products you know and have maybe eaten, have missed this. Kind was cited by the FDA for making this precise mistake in a 2015 Warning Letter.

Labeling rules are not only vast, dense, and potentially confusing – they are also subject to change. In May of 2016, the Food and Drug administration promulgated rules that changed the Nutrition Facts Panel, recalculated Recommended Amounts Customarily Consumed (RACCs), and changed the Daily Reference Values and Reference Daily Intakes of many nutrients.

A good product label requires more than handsome aesthetics. We take a rigorous approach to compliance, but we are also sensitive to the aspirations of our clients. Compliant labeling is an effective tool for risk mitigation, but we also understand that the right kind of legal advice should try to mitigate your risk without sacrificing the central message of your brand.

The responsibility for accurate food labeling needs to be addressed in the supply chain, not just on the product package. In June of 2017, an unlabeled allergen in a single ingredient, breadcrumbs, caused a cascade of recalls by other food manufacturers that incorporated the breadcrumbs into their products. We always recommend that our clients address issues exactly like this in our supplier agreements.

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