Package Violations

Understanding Front-of-Package Violations: Why Warning Letters Are Sent to Industry

Ever wonder if what you say on your label or packaging could draw the attention of the FDA?  It’s always helpful to be able to learn from examples of what’s unacceptable before you release your product packaging.

The FDA has a helpful chart that summarizes  FDA warning letters for nutrition claims on packaging that provides great examples of what to avoid.

So if, for example, your product is intended for children under 2 years of age, you may want to study the chart to understand why the FDA issued multiple warning letters to companies making nutrition claims for products intended for children under 2 years of age.

Good News on Senator McCain’s S.3002, the Dietary Supplement Safety Act?

The dietary supplement industry received good news when Senator John McCain recently backed away from a bill that would have given the FDA greater authority to regulate the industry.  Senator Orin Hatch, who had been critical of the bill, thanked Senator McCain for withdrawing the bill.

Dietary Supplement Manufacturers Encounter “New Drug” Labeling Pitfalls In FDA’s Enforcement of Federal Food, Drug, and Cosmetic Act

Manufacturers of dietary supplements should continue to keep a wary eye toward the claims they make in their product labeling, in light of recent government action.  Regulatory enforcement actions by the FDA, in association with the United States Attorney’s Office, highlight the risks associated with the manufacture and labeling of dietary supplements.

Recently, government ire was peaked when one dietary supplement manufacturer made broad labeling claims touting its products’ ability to diagnose, mitigate, treat, cure or prevent certain diseases (including diabetes, irritable bowel syndrome, gout, high blood pressure, heartburn and diarrhea).

According to the government, the maker’s claims made it subject to several FDCA provisions, including Section 343(r)(6), and corresponding requirements under the Code of Federal Regulations.  Consequently, the claims reflected in the products’ respective labeling resulted in the “designation” of each as a “new drug,” triggering federal regulatory compliance relating to the maker’s submission, and subsequent government regulatory review, of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) or Investigational New Drug applications (INDs), for each product.

After each was designated a “new drug”, the following enforcement action was filed by the United States Attorney’s Office:  United States v. Thao, et al (.pdf).  Further, the “new drug” designation, and the resulting trigger of additional regulatory requirements, left the maker subject to charges stemming from several statutory violations leading to government claims of wire and mail fraud, money laundering and conspiracy.

The stakes associated with inaccurate or overreaching product labeling are high.  Effective guidance through the labeling process, with the advice of counsel familiar with requirements under Federal law, is a must.