The Dr. Rinse Case: An Inside Look at FDA
Dietary Supplement Regulation in the 1980s

Stephen Barrett, M.D.

In 1979, an FDA consumer safety officer named Paul Sage asked me to help gather evidence against Robert F. Linblad, the proprietor of Linblads Inc., which sold vitamins and other products mainly to chiropractors. Sage, who investigated and prepared cases for FDA regulatory action, was concerned that Linblads was marketing "Dr. Rinse Formula" with false claims that it was effective against a long list of serious diseases. (To read the 6-page promotional brochure, click on the image to the right.) The formula is said to have been developed by Jacobus Rinse, Ph.D., a Dutch research chemist who moved to the United States in 1949 [1]. After experiencing chest pain (angina pectoris) in 1951, Rinse experimented on himself and concluded that his formula improved the circulation of blood to his heart [2]. In 1975, Nederma, a Dutch pharmaceutical firm began marketing the formula through health-food stores in Holland under the trade name Linogistine [3]. Marketing under the "Dr. Rinse" name began about three years later in the United States with articles and ads in chiropractic and health-food industry magazines.

  

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.

In 1976, the FDA prosecuted Linblad for shipping an amygdalin product made from apricot kernels with literature claiming that amygdalin (better known as laetrile) was effective against cancer. Linblad pled guilty to two criminal counts and paid a small fine [4]. This case was significant because it was the only one of its kind that the FDA had initiated since the early 1960s. Before that time, the agency had brought many prosecutions and it was clear that marketing quack products with illegal claims could result in imprisonment. But the 15-year absence of stern FDA action had made the agency look like a paper tiger.

Sage reasoned that prosecuting Linblad again would be a cost-effective way to warn like-minded proprietors that illegal marketing was risky. Sage instructed me to order one box of Dr. Rinse with a personal check made out to Linblad personally. Sage said that if Linblad cashed the check, the FDA could prosecute him personally in addition to prosecuting the company. A few days after my order arrived, an FDA agent interviewed me and picked up the product and a copy of the check. (Click here to read the labels.) During the next two years, when I asked about the progress of the case, Sage said that he was not permitted to disclose anything about ongoing investigations. But he eventually said that the relevant FDA official in charge of enforcement had blocked the prosecution—and he sent me a lengthy memo that revealed what had happened.  

The official was Joseph Paul Hile, who served as FDA Associate Commissioner of Regulatory Affairs (ACRA) 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. Sage's memo states that the recommendation to proceed with a criminal search warrant in the Dr. Rinse case was stalled for a year by a "communication problem" in Hile's office, but the final decision not to prosecute was supported by the others who attended the meeting at which this decision was announced [5]. Sage later noted that the FDA sent the manufacturer a regulatory (warning) letter and that the company changed its labeling, making it more difficult to prosecute [6]

During the early 1980s, illegally marketed products flooded the marketplace. Sage believed there were so many 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 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 [7]. The FDA took more than four years to answer the petition [8] 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 [9], 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.

Today, FDA regulation of worthless products is much more vigorous, with a reasonable mix of warning letters, seizures, and criminal prosecutions. There still is room for improvement—particularly with respect to quack devices—but I think Paul Sage would have been pleased.

References

  1. Question and answer: Linogistine. Nedederlands. Tijdtschrift voot Geneeskunde 120:1805, 1976.
  2. Rinse J. Atherosclerosis: Prevention and cure. Prevention Magazine, Nov 1975, pp 57-65.
  3. Walker M. The Dr. Rinse Formula: How to Prevent Hardening of the Arteries. Old Greenwich, CT: Devin-Adair Publishers, 1983.
  4. Notices of judgment on criminal actions: Linblads, Inc., Robert F. Linblad, president, and Elmer A. Linblad, resident agent and director. FDA Consumer 11(3):36-37, 1977.
  5. Sage PJ. Note for the fille: Approach to regulating a serious health fraud—The Dr. Rinse Formula, April 6, 1982.
  6. Sage PJ. Quoted in Food Chemical News, Aug 5, 1985, p 5.
  7. Sage PJ. Citizen petition, July 9, 1984.
  8. Taylor JM. Response to citizen petition, Docket No. 84P-0242/CP
  9. Page PJ. Undated memo, circa 1985.

This page was revised on June 20, 2011.

Links to Recommended Vendors