## Facts

- ChemNutra, Inc. was a Nevada-based company that imported food and food products from China into the United States.
- ChemNutra was owned by Sally Miller and Stephen Miller.
- The Millers caused ChemNutra to contract with U.S. pet-food manufacturers to supply food-grade wheat gluten with a minimum protein content of 75%.
- The Millers also caused ChemNutra to contract with a Chinese exporter to purchase the wheat gluten that ChemNutra intended to sell to the U.S. pet-food manufacturers.
- The Chinese exporter contracted with a Chinese manufacturing company to supply the wheat gluten the exporter would sell to ChemNutra.
- Between late 2006 and early 2007, the Chinese exporter sent more than 800 metric tons of wheat gluten to ChemNutra.
- Wheat gluten was listed by the Chinese government as a food product subject to mandatory inspection before export, but the exporter used an inaccurate product code and allegedly falsely declared that the wheat gluten was not subject to inspection.
- After the wheat gluten arrived in the United States, ChemNutra sold it to U.S. pet-food manufacturers, which used the ingredient in pet food.
- The wheat gluten contained melamine, which the Chinese manufacturer allegedly added to fraudulently inflate the gluten’s protein content.
- Melamine was not approved as a food additive in the United States.
- Over 3,000 cats and dogs in the United States died or became seriously ill after eating pet food made with the melamine-laced wheat gluten.
- The United States charged ChemNutra and the Millers with distributing adulterated food and distributing misbranded food in violation of federal law.

## Issues

1. Whether the wheat gluten containing melamine could be treated as “adulterated food” under the Federal Food, Drug, and Cosmetic Act (FDCA).
2. Whether the charged conduct involving representations about the wheat gluten’s quality (including protein content) supported a theory that the food was “misbranded” under the FDCA.
3. Whether ChemNutra’s importation and sale of wheat gluten to domestic manufacturers constituted prohibited distribution of adulterated or misbranded food in interstate commerce.
4. Whether the individual owners (Sally and Stephen Miller) could be charged along with the corporate importer based on their alleged direction of the contracting, importation, and sales activity.

## Decision

- Publicly available sources describing this case report federal criminal charges alleging distribution of adulterated food and distribution of misbranded food tied to melamine-contaminated wheat gluten sold for use in pet food.
- No published, reporter-available judicial opinion or publicly accessible order tied to Case No. 08-00023-01CR-W-DW was located from free public databases, so a specific court ruling, disposition, or reasoning cannot be summarized here without access to the docket and filings.

## Legal Principles

- Under the FDCA, food may be deemed adulterated when it bears or contains certain added substances that are unsafe or otherwise prohibited under federal law.
- Under the FDCA, food may be deemed misbranded when labeling or related representations are false or misleading in a material respect.
- The FDCA prohibits introducing or delivering for introduction adulterated or misbranded food into interstate commerce; importation and subsequent distribution to domestic manufacturers can satisfy the interstate-commerce element.
- Criminal liability under the FDCA can extend to a corporate entity and, depending on the charged theory and alleged conduct, to responsible individuals who direct or cause the prohibited acts.

## Conclusion

United States v. Miller, Case No. 08-00023-01CR-W-DW (W.D. Mo. 2008), concerns the federal prosecution of ChemNutra and its owners, Sally and Stephen Miller, arising from the importation and sale of more than 800 metric tons of Chinese wheat gluten that allegedly contained melamine and was sold to U.S. pet-food manufacturers, after which thousands of pets reportedly became seriously ill or died; however, without a publicly available opinion or docket materials, the specific court rulings and final procedural outcome cannot be stated from free sources alone.


United States v. Miller, Case No. 08-00023-01CR-W-DW (2008)