United States v. Articles of Drug (826 F.2d 564): A Landmark Case on FDA Regulation

The case United States v. Articles of Drug, 826 F.2d 564 (7th Cir. 1987), serves as a significant legal precedent in the enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA). The ruling highlighted the Food and Drug Administration’s (FDA) authority over products marketed with therapeutic claims, reinforced the importance of compliance with drug approval regulations, and addressed whether certain toothpaste products were considered "new drugs" under the FDCA.

The dispute arose when the U.S. government filed a forfeiture action against Block Drug Company, a manufacturer of oral hygiene products. The government argued certain toothpaste products contained unapproved active drug ingredients and were being marketed with therapeutic claims without FDA approval. The FDCA defines a "new drug" as one not generally recognized among experts as safe and effective for its labeled uses. 21 U.S.C. Sec. 321(p)(2). The court outlined three criteria to determine this general recognition:​

1. Consensus among experts regarding the drug's safety and effectiveness.​

2. Existence of adequate and well-controlled studies providing substantial evidence of safety and effectiveness.

3. Availability of published scientific literature supporting expert consensus on the drug's safety and effectiveness.​

Block Drug Company contended the products were over-the-counter (OTC) drugs, which, they claimed, did not require FDA approval. However, the government asserted that any product making therapeutic claims falls under the FDCA’s definition of a drug and, therefore, must go through the new drug application (NDA) process before being lawfully marketed.

In the case at hand, Block combined sodium monofluorophosphate (sodium MFP) and potassium nitrate into a single toothpaste with claims of providing both protection against cavities (through sodium MFP) and relief from dentin hypersensitivity (through potassium nitrate). Despite multiple warning from the FDA, Block continued to market its toothpaste with anticaries and sensitivity reduction with a single product. The key legal questions in this case included:

1. Whether the toothpaste products in question qualified as drugs under the FDCA.

2. Whether the manufacturer violated FDA regulations by marketing them without prior approval.

3. Whether the government had the authority to seize and forfeit the products based on noncompliance with federal drug approval laws.

Block attempted to utilize both known active ingredients, which are identified as generally recognized as safe and effective for their respective monographs, together to solve two individual issues; cavities and hypersensitivity in teeth. This combination product in turn became a combination drug in accordance with 21 C.F.R. Sec. 310.3(h)(2), requiring Block to obtain a new drug application in order to proceed with its claims.

The Court agreed with the Government in its position the FDA advisory panel during the creation of the anticaries monograph limited its approval of OTC anticaries products to those containing "single active ingredients." 45 Fed.Reg. 20,673-74.

The Seventh Circuit Court of Appeals upheld the district court’s decision in favor of the U.S. government, affirming the forfeiture of the products. The court ruled that:

• The toothpaste contained ingredients with intended therapeutic effects, which legally classified them as drugs under the FDCA.

• Since the products were marketed with claims related to health benefits, they could not be sold without obtaining FDA approval.

• Block Drug Company’s failure to comply with the FDA’s regulatory process made their products subject to seizure and forfeiture.

This case reinforced the FDA’s authority in regulating OTC drug products and clarified that therapeutic claims trigger regulatory oversight. The ruling had lasting implications, including:

• Stronger enforcement of FDA approval requirements for OTC products.

• Greater scrutiny on manufacturers making health-related claims about their products.

• A legal precedent ensuring that consumer health is protected by requiring compliance with established safety and efficacy standards.

Since this Seventh Circuit ruling, the FDA advisory panel revisited this exact issue and now allows the combination of sodium monofluorophosphate and potassium nitrate and a combination product in its 1991 tentative final monograph. Thanks to the Block Drug Company's forward and innovative thinking, we now have the anticaries and hypersensitivity reduction from these two combination ingredients with Colgate Sensitive, Sensodyne and Crest Sensitivity.

Despite this, the United States v. Articles of Drug case underscores the critical importance of FDA compliance for any company marketing products with therapeutic claims. The decision serves as a cautionary tale for businesses that attempt to bypass federal drug approval regulations, highlighting that failure to comply can lead to severe legal consequences, including forfeiture of products. This landmark case continues to shape FDA enforcement policies and protects consumers by ensuring that all drug products meet rigorous safety standards before reaching the market.