On On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, Inc. of New Jersey and marketed the topical products, deemed drugs by the FDA to consumers.
The FDA conducted an inspection in late 2014 that revealed that Stratus was marketing these topical products without first acquiring the required FDA-approved drug applications, which is typically required when marketing drug products under the Federal Food, Drug and Cosmetic Act (“FFDCA”). The FDA found these products to be drugs under the FFDCA, as opposed to cosmetics, like many other topically-applied products, as they were being marketed to treat various diseases and/or conditions, including:
- a solution used to treat excessive sweating;
- an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea and seborrhea;
- a topical ointment used to treat wounds;
- a topical cream and gel to treat psoriasis, eczema and other skin conditions; and
- analgesic ear drops used to treat ear pain.
After the investigation concluded, the U.S. Attorney’s Office filed a complaint in federal court in the Southern District of Florida, alleging that the products sold by Stratus are unapproved new drugs and misbranded drugs under the FFDCA.
The FDA had the authority to seize Stratus’ products under the FFDCA, as explained in detail in the Marketed Unapproved Drugs Compliance Policy Guide. The compliance policy guide states that persons or companies that are marketing unapproved drugs are subject to FDA enforcement at any time. The FDA is not required to, and generally does not give special prior notice to a person or company that a drug product may be subject to enforcement action, including seizures.
The Policy guide also explains the priorities of the FDA for enforcement actions against violators. The enforcement priorities include drugs with potential safety risks, drugs that lack evidence of effectiveness, drugs that are reformulated to evade an FDA enforcement action, and unapproved new drugs that also violate the FFDCA in other ways (such as a new drug violating current good manufacturing practice).
Prior to marketing any product that may be deemed a drug or pharmaceutical product, it is very important that all steps be completed correctly to ensure compliance with, not only the Federal Food, Drug, and Cosmetic Act, but all other applicable laws. To ensure that your drug or cosmetic product is not in violation of federal law, it is important to consult with a seasoned professional.
We offer professional assistance to companies and individuals seeking to comply with all applicable rules and regulations. Our firm offers comprehensive review of structure function claims, label reviews, and health claims to help our clients ensure that their products are in full compliance with FDA regulations. If you would like assistance with your products, please contact us at [email protected].
