Regulatory Compliance Challenges: OTC Drug and Dietary Supplement Labels

With the Food and Drug Administration’s (FDA’s) two announcements earlier this year regarding its interest in altering or improving the Over-the-Counter (OTC) Drug monograph system which could potentially impact labeling, followed by its proposal one week later to revise the nutrition labeling of foods and dietary supplements, it is clear that keeping your product labeling in compliance to regulation is no easy task.

The initial regulation requiring the Supplement Facts table was published in the Federal Register in 1997 and two years later came the format and content requirements (i.e., Drug Facts) for OTC products.  While these regulations brought a certain amount of uniformity to labels making it easier for consumers to compare products, there continues to be differences among brands as to how the regulations are interpreted or how the information itself is presented on the label.  In addition to what is required by these regulations, there are other laws that impact labeling, e.g. the Food Allergen Labeling and Consumer Protection Act and the Dietary Supplement and Nonprescription Drug Consumer Protection Act.  Thirdly, there are individual State requirements that may come into play, such as California’s Proposition 65 requiring notification that a product contains an ingredient that may cause cancer, birth defects or reproductive harm.  And finally, companies must be cognizant of making false advertising claims that could come to the attention of the Federal Trade Commission.

So how can a manufacturer or distributor keep track of all of these requirements?  There are strategies that can be implemented to help navigate this minefield.

Read and become familiar with the Code of Federal Regulations, or at least those titles and sections that are applicable to your products.  They provide the framework from which any label should be developed.

Be vigilant.  Check the Federal Register routinely for new labeling regulations being published.  Be aware of new legislation that gets enacted by Congress.  Monitor the FDA’s website as well as industry press announcements for new safety information that comes to light regarding a specific product or ingredient.

Know your products.  Know what is in them and be familiar with any regulations that are applicable to the individual ingredients or their quantity within the product that may necessitate an allergen declaration or a quantitative content declaration.

Check competitors’ product labels.  Don’t necessarily rely on them to be correct but, depending on the knowledge and experience of their regulatory personnel, they might include information that you missed and it gives you an opportunity to correct your own labels.

Develop label specifications.  Use these to review your labels while they are being developed or revised. This will ensure uniformity of label content between different package sizes and/or among similar families of products.

Invest in proofreading software.  While this might not be feasible for smaller companies or those with a limited product line, such equipment can detect errors in the text and artwork before they become costly.

Learn from mistakes (both yours and others.)  If you get cited by the FDA for misbranding due to an error or omission, or see that your competitor has, check all of your labels to ensure it is not duplicated elsewhere.

Remember that your label is arguably the best advertisement for your product.  While its artwork may provide the initial attraction for a consumer, the content on that label and how it is presented will not only help with the sale but will also keep the product from subsequently being recalled.