Ashely Monti

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In 1999, the Food and Drug Administration (FDA) approved a beta-agonist drug commonly known as ractopamine.[1] Meat producers use ractopamine to accelerate weight gain and promote leanness in pigs, cattle, and turkeys.[2] Today, over 160 countries either restrict or completely ban the use of ractopamine.[3] However, the United States (U.S.) and 25 other countries still permit its use.[4] Most countries have banned or restricted ractopamine due to animal or human health concerns.[5] Many of these countries took a precautionary approach in reviewing the drug because studies have insufficiently demonstrated the drug’s safety.[6] Yet, the FDA fails to adopt a precautionary approach in approving animal drugs, which is highly problematic and concerning for meat consumers, animal welfare advocates, environmentalists, and others alike.[7] Even more concerning is that ractopamine is not the only non-essential, beta-agonist drug on the market. The FDA recently approved a drug known as Experior, which purports to reduce ammonia in cows.[8] Although this may sound like a good, environmentally conscious idea, its known and unknown risks substantially outweigh any benefits.[9] Overall, the U.S. must proceed with caution when approving drugs that are non-essential, non-therapeutic, and only serve some other—likely economic—purpose.

This Note argues that the current approval process for beta-agonist drugs is insufficient to protect animal welfare, the environment, and human health. Part I outlines the current regulatory structure for animal drugs, describes various types of animal drugs, and briefly introduces prior and current legal challenges to beta-agonist drugs. Part II illustrates how the current regulatory scheme fails to protect animal and human health through an analysis of those legal challenges. Then, Part III dives into the various ways the FDA could promulgate rules to better safeguard animal welfare, the environment, and human health. Finally, Part IV discusses how these new rules could restore consumer confidence in the FDA’s decisions.

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[1] Lindsay Chichester et al., Beta-agonists: What are they and should I be concerned?, Univ. Nebraska-Lincoln, https://newsroom.unl.edu/announce/beef/2563/14863 (last visited May 18, 2021).

[2] Food Safety Fact Sheet: Ractopamine Factsheet, Ctr. for Food Safety (2013) [hereinafter Factsheet], https://www.centerforfoodsafety.org/files/ractopamine_factsheet_02211.pdf.

[3] Delcianna Winders, Why are U.S. Factory Farms Feeding Animals A Drug Banned in Most Countries?, Million Dollar Vegan (Mar. 10, 2020) [hereinafter Banned Animal Dug], https://www.milliondollarvegan.com/why-are-u-s-factory-farms-feeding-animals-a-drug-banned-in-most-countries/.

[4] Factsheet, supra note 3.

[5] Id.

[6] Id.

[7] Susan A. Schneider, Beyond the Food We Eat: Animal Drugs in Livestock Production, 25 Duke Env’t. L. & Pol’y F. 227, 255–61 (2015) [hereinafter Beyond Food].

[8] FDA in Brief: FDA Approves First Animal Drug that Reduces Gas Emissions from an Animal or its Waste, U.S. Food & Drug Admin. (Nov. 6, 2018), [hereinafter FDA in Brief], https://www.fda.gov/news-events/fda-brief/fda-brief-fda-approves-first-animal-drug-reduces-gas-emissions-animal-or-its-waste.

[9] Complaint at ¶¶ 1–14, Animal Legal Def. Fund v. Azar, No. 03-703 (N.D. Cal. June 4, 2020); see FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste, U.S. Food & Drug Admin. (Nov. 6, 2018), https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-experior-reduction-ammonia-gas-released-beef-cattle-waste#:~:text=The%20U.S.%20Food%20and%20Drug,by%2Dproduct%20of%20their%20waste (explaining how ammonia gas emissions contribute to atmospheric haze and noxious orders, which can irritate the eyes, nose, and throat in humans and animals. In addition, ammonia gases contribute to eutrophication, which leads to algae blooms).