Avoiding Liability Through a Focus on Regulatory Compliance
The attorneys of Ullman, Shapiro & Ullman advise clients nationwide on compliance issues relating to the federal regulation of the natural foods and nutritional supplements industries. Our expertise covers issues ranging from the safety and efficacy of new products to basic operational considerations under current good manufacturing practices and accurate labeling. Whether these issues are of concern to an established company or an emerging our attorneys are ready to provide support based on our decades of experience with food, drug and consumer product safety regulation.
Our lawyers offer dependable advice and prompt answers to questions concerning your responsibility to comply with rules and regulations enforced by a variety of federal administrative agencies, including:
- Food and Drug Administration (FDA)
- Federal Trade Commission (FTC)
- Consumer Product Safety Commission (CPSC)
- U.S. Drug Enforcement Agency (DEA)
- U.S. Customs and Border Protection (CBP)
Avoiding Potential Violations of FDA and FTC Regulations
Although the rules of numerous federal and state agencies can affect your business in the nutritional supplements industry, most of our clients are especially concerned about FDA and FTC compliance and enforcement issues. FDA compliance is primarily concerned with product labels and labeling and the nature of claims made for these products (an improperly crafted claim can cause a dietary supplement to be regulated as a “unapproved drug”). On the other hand, FTC compliance relates more to how the products are advertised to consumers and the use of testimonials and endorsements. The need for an accurate ingredient list, truthful product claims and adequate substantiation of claimed product performance is paramount.
The consequences of noncompliance can be serious. You run the risk of a consumer class action lawsuit. Your company might lose the whole of its profits from a product found to violate FTC rules and be subject to a 20-year decree. A product recall or product safety violation could not only hurt you in the market for a long time, but could also expose you to the risk of criminal prosecution.
For additional information about our ability to provide protection from regulatory risk to your company through sound advice on compliance issues, contact Ullman, Shapiro & Ullman in New York.