## Facts

- The United States, acting through the FDA, filed an in rem action under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking seizure and condemnation of vitamin, mineral, and other dietary preparations found in Foods Plus, Inc.’s possession.
- The products were seized pursuant to 21 U.S.C. § 334(a); Foods Plus filed a claim and contested misbranding allegations.
- Foods Plus distributed a printed “Foods Plus 1962 Vitamin Catalog” with the products; the catalog described products, suggested dosage, and made health-related representations.
- The catalog included statements implying product superiority because the preparations were formulated by Carlton Fredericks, described as an “internationally prominent nutritionist.”
- For multiple products, the catalog represented effects such as promoting vigor, promoting children’s growth, converting fat to energy, and preventing tiredness or poor appetite.
- Carlton Fredericks, a radio nutrition commentator closely associated with Foods Plus, discussed Foods Plus products on radio programs and directed listeners to obtain products from Foods Plus.
- The government alleged Fredericks’s broadcasts represented the products as effective in preventing or mitigating disease conditions, while the container labels and catalog did not provide directions for such disease-related uses.

## Issues

1. Whether the Foods Plus vitamin catalog constituted “labeling” under the FDCA for purposes of determining misbranding.
2. Whether radio broadcasts closely tied to the products’ marketing and distribution could be considered in evaluating whether the products were misbranded.
3. Whether the products were misbranded under 21 U.S.C. § 352(a) because the labeling was false or misleading in any particular.
4. Whether the products were misbranded under 21 U.S.C. § 352(f)(1) because the labeling failed to bear adequate directions for use consistent with promoted disease-related or health-related claims.

## Decision

- The court held the vitamin catalog constituted FDCA “labeling” and could support misbranding findings.
- The court treated Fredericks’s broadcasts, given their close association with Foods Plus’s sales scheme, as relevant communications in assessing product representations.
- The court found the products misbranded under § 352(a) because the labeling, taken as a whole, was misleading, including superiority implications and broad health claims.
- The court found the products misbranded under § 352(f)(1) because the disease-related and other promoted uses were not matched by adequate directions for use for lay consumers.
- The court ordered condemnation of the seized articles as misbranded drugs under 21 U.S.C. § 334, subject to statutory disposition procedures.

## Legal Principles

- “Labeling” under the FDCA extends beyond container labels to materials that accompany a product and are used to describe, promote, or instruct its use, including catalogs distributed with the goods.
- Promotional communications functionally connected to product distribution may be considered with other labeling materials in determining the overall representations made to consumers.
- Under 21 U.S.C. § 352(a), labeling may be “misleading” based on the net impression on ordinary consumers, including implications, ambiguity, and overall context, not only literal falsity.
- When products are represented as effective for disease prevention or mitigation, 21 U.S.C. § 352(f)(1) requires labeling to provide adequate directions for use for those represented purposes; failure to do so independently renders the product misbranded.
- Courts may evaluate an integrated marketing scheme (product + accompanying printed matter + coordinated promotional statements) to determine whether misbranding requirements are violated.

## Conclusion

The court condemned the seized dietary preparations as misbranded because accompanying promotional materials, including a catalog and closely connected radio representations, constituted labeling that created misleading impressions and extended product uses beyond what the labeling instructed, while failing to provide adequate directions for those promoted uses.


United States v. Articles of Drug Consisting of Undetermined Quantities of Vitamin, Mineral, & Other Dietary Preparations … Foods Plus, Inc., 239 F. Supp. 465 (D.N.J. 1965)