No product is ready to hit the shelf until it has undergone a thorough labeling compliance check. We refer to this as a “label review”, and our clients know to seek our guidance when designing labeling and marketing. Product labeling can be regulated by the FDA, the USDA, or the TTB. Getting it wrong exposes food manufacturers to a range of 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.
The 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 nutrient content claims like “low fat” and “high fiber”, and much more.
Food Labeling Pitfall: The Disclosure Statement
A typical nutrient content claim involving fiber 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)). That part of the rule is a straight-forward math problem. So far, so good.
- However, there is an important requirement for fiber claims that is not required when making many other “high” claims. 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)). To find the additional requirement, you’d need to know to read further down in the regulation.
- This is called a “Disclosure Statement”. The disclosure statement is required when a nutrient content claim is made about one ingredient and another nutrient considered “unhealthy” is present in an amount that exceeds certain prescribed levels.
We spot issues like this routinely during a label review. Even successful companies, whose products you know and have maybe eaten, miss details like this. Kind was cited by the FDA for making this precise mistake in a 2015 Warning Letter.
Food Labeling Pitfall: The Antioxidant Claim
Manufacturers get tripped-up on anti-oxidant claims all the time, which can be just as enigmatic as the “Disclosure Statement” example described above. Food products cannot characterize the amount of an unspecified anti-oxidant using relative terms such as “high” or “excellent”. Here is why:
- A product cannot make a relative claim of “high” or “low” for any nutrient unless the FDA has established a Daily Value for the nutrient that is subject to the claim.
- The FDA has not published a Daily Value for the group of nutrients classified as “anti-oxidants”.
- FDA has, however, published Daily Values for nutrients that are classified as antioxidants, like beta carotene when present as Vitamin A, or Vitamin E.
If you apply these rules, a product cannot say “An Excellent Source of Antioxidants”. However, a product can say “An Excellent Source of the Antioxidant Vitamin E”, or “Rich in the Antioxidant Vitamin A”, so long as those nutrients are present in excess of 20% of the Daily Value published by the FDA.
Without a thorough label review, the antioxidant labeling rules will confound even the big manufacturers. The FDA cited Snapple for violating the antioxidant labeling rule in 2010.
The Rules, They Do Change
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 totally revolutionized the Nutrition Facts Panel, recalculated Recommended Amounts Customarily Consumed (RACCs), and changed the Daily Reference Values and Reference Daily Intakes of many nutrients.
Our Label Review Philosophy
- We participate in your idea generation by integrating into your team.
- We think about your labeling and marketing in the context of your supply chain and manufacturing agreements.
Integration. Years ago, when we billed strictly on an hourly basis like a typical law firm, clients would ask us to perform a label review as a last step before the labels went to print. By the time we were asked to perform the label review, leadership, marketing, and design teams had put lots of thought and energy into the marketing strategy. We would then tear the label to pieces, and the website copy that supported it. To do our job meant that we often had to rip the core out of the marketing strategy, a wasted investment in time and talent. Marketing teams and graphic designers billed the food business for a second round for reconceptualizing everything, and production delayed.
Because we now bill on a subscription basis, we made it easy to integrate legal services during conceptualization. Clients are much more comfortable putting us on the team at the beginning of the creative process, not at the end. We can train the team on the regulatory parameters and be on stand-by for any follow-up questions during design. When we are asked to perform the final label review, we usually review a flawless label. There are no re-design fees or printing delays. We’ve made the label review process efficient because we made it easy to get plugged-into your business.
Context. Doing label review also makes us think about your product in the context of your entire supply chain. 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 can make sure that our clients address issues exactly like this in their copacker agreements and private label agreements.
Our subscription service
Clients realize the greatest value out of our services when they stack them together comprehensively. Our subscription-based service plans enable our clients to weave our services into the fabric of their businesses at affordable and predictable rates.