There was a time in my life when staying out of trouble consisted mostly of knowing when to hide from my mom. As a child, my highly honed hiding skills spared me any number of spankings. Now days staying out of trouble consists of not doing illegal acts. This can be challenging when you have friends who want you to do them a favor.

Just the other day a friend of mine called me. He raises sheep. He wanted to feed them Paylean (ractopamine). I told him that we feed Paylean to hogs, not sheep. The conversation went something like this:

Him: Hey, Doc, I got some finishing lambs that’s kinda’ scrawny. I want to feed them Paylean. What do think of hitting them with 18 grams per ton?

Jim: I think that is a really stupid idea. You can’t feed Paylean to sheep.

Him: Why not? They are my sheep.

Jim: Because Paylean is not approved for use in sheep—such use is illegal. The feds might say all sorts of very scary things like “federal offense” or “non compliant” or “injunction.”

Him: So? Lots of things say they’re federal offenses. Like they’ll notice.

Jim: So the FDA might say things like “substantial fines and penalties for each violation” or “criminal prosecution.” Phrases like that make me want to pay attention.

Him: If that’s so stupid, I have a lot of stupid friends.

Jim: I’m not sure I like the implication—if I’m a friend of yours.

Him: OK, so explain why I should pay attention to these FDA regulations.

Jim: I’m glad you asked. The Food and Drug Administration—the FDA—is an agency of the Department of Health and Human Services, which is part of the executive branch of the federal government. FDA is a regulatory agency. It is one of several public health agencies, and it is charged with protecting consumers from products that are not safe, or pure or effective. FDA is responsible for ensuring the safety, wholesomeness and economic integrity of food. The principle law enforced by FDA is the Food, Drug and Cosmetic Act. FDA issues regulations which dictate how the law will be enforced.

Him: Yes, but what happens if I don’t comply with FDA?

Jim: First, rest assured. I’ll come visit you if you go to jail. In simple terms, there are two ways to achieve the objectives of any law. One is by informing and educating the regulated groups so they will not do what is forbidden. The other is by taking action in the courts if the law is broken. FDA works to make sure the industry knows the requirements of the law. This is sometimes called “preventive enforcement.” In this way violations are kept to a minimum. However, when FDA discovers that a product does not conform to set standards, the agency has several legal recourses which it can take. They can seize the product. The seizure of a food, drug, cosmetic, device or biological product that violates the federal Food, Drug and Cosmetic Act is an action taken against the product, not against the owner. Its purpose is to prevent consumption or use of the seized product. When by inspection or laboratory analysis, FDA discovers a product that has crossed state lines does not conform to the law, the FDA requests the Department of Justice to file a “libel,” as the FDA calls it, with the proper federal court. Acting on a warrant issued by the court, a U.S. marshal seizes the articles. The owner is notified and given an opportunity to appear in court to contest the government’s charges. If the owner of the seized products fails to appear in court, the case is disposed of—by default. This means that the court accepts the charges of FDA and no one challenged it. Or, the owner may appear in court, admit that the product violates the law and request to be given the opportunity to bring it into compliance.

Then things grow more interesting. The entity responsible for violating the federal Food, Drug, and Cosmetic Act may be subjected to a criminal prosecution with escalating fines and possible jail time.

And for shifty players, there are injunctions or restraining orders. These are used when a person or a firm has a record of repeated violations. A big part of the government’s case in an injunction action is to show that if the injunction is not issued another violation will probably occur. Violation of the injunction amounts to contempt of court and may be punished accordingly.

Him: Hey, Doc, I see the light. I don’t want to use anything but approved feed additives or approved combinations.

Jim: Glad you do. MFA feeds have only approved additives at approved and appropriate concentrations for the intended purpose. So get those sheep a legal complete feed and forget the Paylean.