FDA Food Labeling Review and Compliance

The Food Law Firm is your go-to resource for mitigating recalls, FDA Warning Letters, or class action lawsuits from plaintiff’s attorneys. For label review services that will keep your food business compliant, contact us today.
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No product is ready to hit the shelf until it has undergone a thorough labeling compliance check, and there are many other complex regulations food manufacturers must comply with. The Food Law Firm’s unique subscription-based plans give you access to our skilled legal counsel for everything from copacking agreements to confidentiality agreements, and more. 

By packing our services as a subscription, we give businesses access to a wide array of legal services and the comfort of having a team of experts behind you. 

If, however, a limited consultation is for you, then we’d be delighted to review your labeling with traditional hourly billing.

Traditional law firms are slow, often fail to understand your overall business priorities and goals, and charge you minute-by-minute for each interaction. The Food Law Firm’s subscription-based packages change that. Not only do you get comprehensive legal services, you get to select a plan that fits your budget, has consistent pricing, and doesn’t hit you with surprise fees or charges.

In addition to receiving expert legal counsel across our service lines, our clients love that we:

• Don’t charge fees for calls or emails lasting fewer than 15 minutes.
• Provide simple, direct access to our team of experts and attorneys.
• Take a holistic approach to your business’ legal needs.

Label review is a comprehensive check to ensure food product labels meet compliance standards. 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.

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. 

Our label review philosophy is simple, and is rooted in two rules: 

1. We participate in your idea generation by integrating into your team.
2. We think about your labeling and marketing in the context of your supply chain and manufacturing agreements.

So what do we mean by this?

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. We then had the displeasure of tearing the labeland the website copy that supported it to pieces. 

To do our job well meant that we often had to rip the core out of the marketing strategy, resulting in a wasted investment in time and talent. Marketing teams and graphic designers billed the food business for a second round of designs, and production stalled.

Today, we bill on a subscription basis. Because of this, we make it easy to integrate legal services during conceptualization, and the results have been outstanding. Clients are much more comfortable putting us on the team at the beginning of the creative process, not at the end. Additionally, we can train the team on the regulatory parameters and be on stand-by for any follow-up questions during design. 

Finally, when we are asked to perform the final label review, we usually review a flawless label because we’ve been involved each step of the way. Your business saves money because there are no re-design fees, printing delays, recalls or regulatory fines. We’ve made the label review process efficient and cost-effective 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.

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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