Label & Claims Review

The Food and Drug Administration (FDA) label & claims review and regulations consist of hundreds of pages containing thousands of rules, options, and critical details that you must follow.

Beyond the regulations, you must also contend with many written and unwritten FDA policies. All of these apply to your product labels, as well as other advertising and marketing efforts.

Failure to comply with FDA labeling requirements can result in Warning Letters, import detentions, placement on Import Alerts (automatic detentions), and, in the case of allergen labeling, nationwide product recalls.

Having an advocate that has extensive experience in navigating these regulations and possible enforcement actions is critical to keeping your product on the market.

FDA & FTC Jurisdiction
The FDA regulates the labels of all products under its jurisdiction, such as foods, supplements, drugs, medical devices, and cosmetics.

Labeling violations are one of the most frequent problems companies face with the FDA. These violations can lead to various FDA enforcement actions, which can cause loss of profits, delays, damaged relationships with customers and distributors, and damage to your brand reputation.

In addition to the FDA, companies need to comply with Federal Trade Commission (FTC) law. The FTC regulates the advertising for all FDA-regulated products, focusing almost entirely on the truthfulness of advertisers’ claims.

In addition to the FTC, the Better Business Bureau’s National Advertising Division (NAD) privately enforces FTC standards and then reports violations to the FTC, FDA, and private class action attorneys. Both the FTC and private class action plaintiffs can obtain massive money judgments from companies using false and misleading advertising.

Consequently, FTC and related advertising violations for misleading claims are some of the most monetarily costly violations you can commit. By hiring experienced counsel to help you comply with FDA and FTC labeling and claims requirements, you can significantly reduce the risk to your brand and bottom-line.

Label & Claims Review Terms to Familiarize Yourself With
Learning these terms will help you understand labels and claims.

Label –The written, printed, or graphic material on the package (the immediate container, not including liners).

Labeling –The written, printed, or graphic material on the product, its container, wrappers, or accompanying a product (an insert or rack card).

Misbranded – There is a problem with the product label. It means that the label or labeling violates FDA law because it has false or misleading statements, or otherwise lacks required label or labeling statements.

FTC – The Federal Trade Commission, which is tasked with regulating advertising, among other things.

NAD – The National Advertising Division of the Better Business Bureau, which purports to be a private self-regulatory body. They bring cases of their own initiative or after being paid by an industry member (i.e., your competitor). When the NAD initiates a case, they demand evidence of claims substantiation. If the NAD is unsatisfied with the company’s substantiation, they will report the company to the FTC and/or FDA and issue a negative press release. The press releases are monitored by class-action attorneys looking for cases.

Class Action – A lawsuit where there are numerous plaintiffs represented by a member of the group. Because of the number of plaintiffs, class action lawsuits can have some of the highest money awards.

How an FDA Attorney Can Help

We can help you with a new or ongoing enforcement action. If you already face an FDA detention or Warning Letter, an FTC (Civil Investigative Demand), or an NAD case, we can quickly evaluate your situation, respond to the government, help you control the damage, and create a plan to avoid future such issues.

Some of the most common labeling issues likely to lead to FDA or FTC action
  • Unsubstantiated claims.
  • Labels lacking required elements, such as a statement of identity, drug or nutrition facts, net quantity, or ingredient lists.
  • Claims taking your product out of your intended category, such as claims that make a cosmetic product into an illegal, unapproved new drug.
  • Missing or incorrect allergen labeling.
  • Language violations.
  • Claims not permitted for the product or product type.
We are experienced at responding to government enforcement actions, but we are just as experienced in helping clients avoid enforcement action.

We routinely help clients bring their labels, advertising, and websites into compliance. We also help in evaluating claims substantiation (required by FTC) and in drafting compliant and robust claims. Our reviews and advice will give you confidence that your labels and marketing are legal and unlikely to result in violations.

We will help you with the following
  • Label Review: A written document that details all required and recommended changes to comply with FDA regulations. This includes a review of the label claims and ingredient declarations.
  • Claims Review: A written review of claims that the company will use in labels, advertising, and websites.
  • Advocacy: We will represent you before FDA, FTC, NAD, and even state regulators that bring charges against your products, labels, or advertising.

We have handled numerous and varied government enforcement actions. We have also reviewed hundreds of labels and websites for foods, drugs, dietary supplements, medical devices, and cosmetics. Let us be your advocates and advisors.

Solve Your FDA Problems
Imagine focusing on growing your business without the stress of having to deal with regulatory issues.

Take the first step to freedom and schedule a call with us today.

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