FDA Food Labeling Review and Compliance

Believe it or not, that eye-catching and artful product label is probably the biggest risk to your food business. A food labeling error can be the source of industry scourges like FDA Warning Letters, product recalls, or class action lawsuits from plaintiff’s attorneys. No product is ready to hit the shelf until it has undergone a thorough labeling compliance check. Most label review consultations have a 2-3 day turn around time. For label review services that will keep your food business compliant, contact us today.
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Label review entails a comprehensive check of your product and its ingredients to ensure it complies with federal labeling laws. Product labeling can be regulated by the FDA, the USDA, or the TTB. Getting it wrong exposes food manufacturers to a range of risks:

• Food products that deviate from regulation in any way could be considered misbranded
• Labeling errors or misbranded foods can 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..
• Class action sharks are constantly on patrol for errors that create five- and six-figure headaches for Marketers.

Label review is essential for catching errors that may seem like small details, but can have massive implications for the success of your business. 

A typical nutrient content claim involving fiber provides the perfect example of how tricky it can be to market a product while navigating the complex regulations outlined by the FDA: 

• 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. That part of the rule is a straight-forward math problem. So far, so good.
• However, unlike with  other “high” claims, if a high-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. To find the additional requirement, you’d need to know to read further down in the regulation.
• This is called a “Disclosure Statement”. A 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.

At the Food Law Firm, we spot issues like this routinely during a label review. Even well-known companies miss details like this: the producers of KIND snack foods were cited by the FDA for making this precise mistake in a 2015 Warning Letter.

Manufacturers get tripped-up on antioxidant claims all the time, which can be just as enigmatic as disclosure statements. Food products can’t characterize the amount of an unspecified anti-oxidant using relative terms such as “high” or “excellent.” Here’s why:

• A product can’t make a relative claim of “high” or “low” for any nutrient unless the FDA has established a Daily Value for that nutrient..
• The FDA hasn’t published a Daily Value for the group of nutrients classified as antioxidants. 
• However, the FDA has 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,” but it could say “An Excellent Source of the Antioxidant Vitamin E,” 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 can confound even the big manufacturers—in fact, the FDA cited Snapple for violating the antioxidant labeling rule in 2010.

Labeling rules are not only vast, dense, and potentially confusing – they’re also subject to change. In May of 2016, the FDA promoted new 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.

The Food Law Firm’s team of experts and attorneys keeps a close watch on developments in food regulation, labeling, and compliance so you can focus on creating outstanding products. 

There are two ways to perform a label review.

The “Red Pen” Method. We commonly get labels to review that have already been through the design phase. The product has already been formulated to meet a certain dietary need in the marketplace. Around that formulation, the artwork has been generated and agreed upon (and paid for), and the Food Law Firm is the last stop before printing. We then take a red pen to the copy and provide corrective guidance to the client. Clients then need to go back to artists and designers and pay again for the edits. In order to do our job, we often had to rip the core out of the entire marketing strategy, resulting in a wasted investment in time and talent. While there is never a “wrong time” to catch a critical mistake, there is a better way to give labeling advice.

The “Sandbox” Method.

A product launch is always a team lift, and a good product seldom launches from the mind of a single individual. The earlier you can integrate our guidance, the less corrective action and waste you will experience in your development cycle. If you can put us in the room when the copy is being generated, we can describe the regulatory parameters for compliant marketing. The legal guidance builds the “sandbox” for the creative types to play in. Better still, we can advise when a new product is being formulated, so that we can help make sure the nutrient profile of the product can substantiate the labeling claims you want to make. It is literally never too early to get our guidance on product marketing.

Context

There is a synergistic aspect to our label review philosophy. We think about your label in the context of your entire supply chain, which includes your co-packer relationship. Accurate food labeling needs to be addressed in the supply chain, not just on the product package. 

For example, 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.

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.

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