Why the FDA Should Use More Criminal Prosecutions

Stephen Barrett, M.D.

During the early 1980s, illegally marketed health products flooded the marketplace. The FDA official in charge of enforcement actions was Joseph Paul Hile, who served as FDA Associate Commissioner of Regulatory Affairs from 1976 through 1986. Many observers regarded Hile as a tough, effective regulator, but he had very little interest in quackery-related cases. During his tenure as the agency's third-highest ranking official, the FDA did not initiate a single quackery-related criminal prosecution, and several FDA enforcement officials told me that he often blocked the issuance of warning letters.

During Hile's reign at the FDA, I reported many violations, helped with several investigations, served as an occasional consultant, and was interviewed by many reporters who were concerned about FDA inaction. I also met and spoke with many FDA enforcement officials at consumer-protection conferences. I was also part of a team at Consumer Reports that tried to get the agency to become more aggressive. My activities were sufficiently prominent that in 1984, I received an FDA Commissioner's Special Citation Award for Public Service in fighting nutrition quackery. My activities sparked the interest of Paul Sage, an FDA consumer safety who saw me as a valuable ally in trying to deal with the problem of quack products.

The Federal Food, Drug, and Cosmetic Act defines "drug" as any article (except devices) "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." These words permit the FDA to stop the marketing of products with unsubstantiated "drug" claims on their labels. If a product's labeling lacks required information or contains false or misleading information, the product is misbranded. Marketing a drug that is unapproved or misbranded is a criminal offense. A first offender may be imprisoned for up to one year. Any subsequent offense is a felony punishable by up to three years in prison. "Labeling" is not limited to what is on a product's container. It also includes claims made by any written or graphic matter that explains a product's use and is physically or contextually connected with its sale.

Sage believed there were so many illegal promotions that civil action on a case-by-case basis was impractical, but if criminal sanctions were used routinely, future violations of this kind would be deterred. He also believed that criminal cases would require less of the agency's resources than civil cases because they are simpler to carry out. In 1984, Sage he tried to loosen Hile's control by filing a petition—as a private citizen—asking the FDA to change its enforcement policy so that criminal prosecution became routine [1]. The FDA took more than four years to answer the petition [2] and did so only after I threated to sue if they continued to ignore it. Meanwhile, the FDA's Litigation and Recall Staff (the team that prepared cases for enforcement) was disbanded [3], Sage was reassigned elsewhere, and the agency's relative indifference to what Hile called "economic frauds" (products that were misrepresented but not cause direct physical harm) continued until he retired.

In 1985, Sage sent me a hand-written letter explaining why he believed that the FDA should focus on criminal prosecutions:

I believe that using civil litigation will usually be wasteful. There are several reasons for this.

First, if you consider returns per unit of resources invested, criminal cases are vastly more efficient. Consider a firm that markets 15 to 20 violative products, preferential use of criminal charges lets you focus on one or two products, the most egregiously violative and set the violations up for a second offense felony conviction on any subsequent violation. Trying to attack all violative products at once with civil seizures would mean the government would have to make it make its case against every product. This would be very burdensome and inefficient. FDA would soon choke on the load.

The second disadvantage would be would flow from the inherent differences between civil and criminal litigation. In civil cases, the defendant can use the Rules of Civil Procedure to place enormous burdens on the government. Depositions can be taken from dozens of prospective witnesses. We can be compelled to produce mountains of documents. Interrogatories can be used to ask almost endlessly complex questions in the guise of exploring for evidence. Your own lawyer will tell you that discovery in civil litigation is often exceedingly complex and burdensome. Remember, too, that as long as the costs of the products, their promotion, and the litigation do not exceed product sales, it pays the quack to litigate. There is no penalty as long as the bottom line shows a profit.

In criminal cases, on the other hand, there is a penalty. The actions are essentially punitive. Discovery is much more limited, far less burdensome. In fact, most of the burden is on the defendants. They must comply with grand jury subpoenas. They must produce witnesses. Proceedings of the grand jury are secret and not open to discovery. Ordinarily, depositions and interrogatories cannot be used.

Civil litigation also invites negotiation that in itself is often disadvantageous. Judges often force settlements. Overt claims maybe trimmed back, but promoters often wind up with products that they can continue to market to exploit the reputation that they have established by their previous promotion. They do this with the blessing of the court and government. Quacks love this kind of negotiation. They never lose.

If FDA announced its intent to seize violative products in advance, the marketers could respond in two ways. They could file suits for declaratory judgments in jurisdictions of their choice. More important, they could initiate a political response to scuttle the action. Criminal cases do not lend themselves to the same kind of political influence because this would carry the risk of obstructing justice. Politicians shy away from this risk

I think that the FDA's management would be happy to see you press for anything but more routine use criminal prosecution. If we could persuade the Commissioner to adopt the policy and the compliance program that would stimulate development of the kind of small, simple, non-political cases you developed with Consumers Union. I could manage well over a dozen such prosecutions a year and a well-managed fraud branch should be able to handle 50 to 60 such cases. I hope that you will not lead Joseph Hile or the Commissioner to think that agreeing two or three cases a year would be a satisfactory achievement. In today's environment, with so many easy cases to be made, it would be far from enough.

Consider this too. I think FDA would like to be under pressure to bring a variety of different kinds of cases. That we give the agency an excuse the weigh the pros and cons of every possible regulatory alternative even more carefully and waste more time pondering than doing.

Finally, remember that there aren't enough trucks around too haul off $10 million worth of quack remedies if we did have the resources to seize them. We should strive to keep attention focused on the people who commit the violations. Except in rare cases, it would not be practical to attempt to control this problem otherwise.

— Paul Sage, September 5, 1985

Today, FDA regulation of worthless products is more vigorous, with a mix of warning letters, seizures, and criminal prosecutions. But it is not enough to cope with the huge increase in illegal activity promoted through the Internet. Paul Sage was right that the only way to deter product-related crimes is to reduce the odds of profiting from them. Systematic criminal prosecution is necessary to do this. This is as true today as it was when Sage penned his insightful words.


  1. Sage PJ. Citizen petition, July 9, 1984.
  2. Taylor JM. Response to citizen petition, Docket No. 84P-0242/CP.
  3. Sage PJ. Undated memo, circa 1985.

This article was posted on July 27, 2018.

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