|Reprinted from FDA Consumer, March 1993|
It looked like business was good. The Green Bay, Wisconsin, firm had expanded its line from over 100 products in the fall of 1985 to nearly 300 in the summer of 1989. Then, one day late in 1992, production came to a halt by order of a consent decree of permanent injunction prohibiting the company from manufacturing, promoting or selling unapproved drug products.
The injunction against Enzymatic Therapy, Inc., entered Nov. 5, 1992, followed a six-year FDA investigation prompted by reports to the agency of serious injuries and a death following use of so-called "nutritional supplements" manufactured by the firm. Enzymatic Therapy signed the consent decree without admitting to any violations of the Federal Food, Drug, and Cosmetic Act.
In the complaint for injunction, FDA alleged that promotional literature, printed and distributed by Lem's Contract Printing, Inc., claimed the supplements could prevent or cure a panoply of ills ranging from obesity, aging and low sex drive to cancer, AIDS, heart disease, muscular dystrophy, arthritis and collagen disease, cystic fibrosis, diabetes, liver disease, bacterial and viral infections, glaucoma, and mental retardation.
From November 1984 to July 24, 1985, FDA received three consumer complaints about Enzymatic Therapy products. One consumer claimed she became dizzy and violently ill after taking the firm's Allernex No. 330 capsules, purchased at a health store in Lincoln, Neb.; another complained of tissue damage after using Dermazyme No. 101 ointment purchased from a Burien, Wash., health food store; and the third complained of a product purported to aid hypoglycemia., purchased from a Cedar Rapids, Iowa, health food store.
An FDA employee posing as a customer telephoned Enzymatic Therapy and requested information about its products. In response, the company sent materials promoting its products. The return address on the envelope was that of Lem's Contract Printing.
In late August and early September 1985, FDA inspected Enzymatic Therapy and found the firm was distributing more than 100 products it promoted for treating and preventing various diseases and conditions. According to the investigator, Terrence J. Lemerond, founder and president of Enzymatic Therapy, refused to provide specific product formulations or records of product distribution, and he denied he had any association with certain of the materials sent to the FDA employee.
Lemerond also told the investigator he had stopped distributing three products -- HI-BP, Raw Thyroid Complex, and L-tyrosine Thyroid Complex-because he had been informed that FDA considered these products illegal.
On Dec. 19, a physician in Houston reported to FDA that one of his patients had died after taking Enzymatic Therapy's Raw Thyroid Complex. A follow-up investigation of the Spring, Texas, health food store where the product was purchased showed the firm had continued to distribute Raw Thyroid Complex after Lemerond had promised to stop.
On June 26,1986, FDA sent Lemerond a letter warning that several of his firm's products were unapproved new drugs because they carried unsubstantiated health claims. The letter also said the products were misbranded because the labeling was false and misleading and failed to bear adequate instructions for use. Further, the letter warned that if Enzymatic Therapy continued to sell these products, it would be subject to other regulatory actions, such as seizure or injunction.
Lemerond's attorney responded with a letter claiming that Enzymatic Therapy rigorously screened and monitored all labeling to ensure its products were not misbranded and denied the firm made therapeutic claims in its labeling.
A second warning letter sent the following month was answered with another denial regarding the claims and specifically denying the firm was responsible for certain promotional materials accompanying its products.
On March 27, 1987, a Fort Smith, Ark., hospital notified FDA of a patient who, after taking Enzymatic Therapy's Raw Thyroid Complex, suffered an elevated thyroid level and was admitted to intensive care. Lemerond again promised FDA to stop selling the product.
Between January 1988 and July 1989, FDA investigators twice more inspected Enzymatic Therapy (with Lemerond again refusing to provide sales records of promotional materials, according to the investigators); inspected health food stores that sold the firm's products; and made an undercover buy from Enzymatic Therapy.
In May 1989, undercover FDA employees from the Chicago district office attended an Enzymatic Therapy sales training seminar at which all the participants were required to sign the following statement:
I am not employed by any Federal, City, or State agency under the control of the Health Department, Food and Drug Administration, or any other governmental or consumer agency. I do not work indirectly with any government agency. I also will not tape this seminar for any government agency to be used against Enzymatic Therapy.
The employees signed the statement and attended lectures they said described how the firm's products benefit the immune system and system detoxification. They were given materials recommending the firm's products for serious illnesses, "Health Guides" describing the firm's products, and an order form with Lem's Contract Printing's return address. Following a July 1989 inspection, Lemerond and his attorney requested a meeting with FDA to discuss the inspection findings. According to the complaint for injunction, Lemerond admitted some of his products were illegal and made unsubstantiated claims. He promised he would cooperate more with FDA in the future. Two weeks later, the attorney sent FDA a letter stating that many of the promotional materials FDA collected were being destroyed or discontinued and that Lemerond intended to submit revised labeling and other promotional materials to FDA for agency review. Nevertheless, during several follow-up inspections of health food stores in March 1990, FDA investigators collected promotional materials containing health claims, including some identical to those Lemerond had promised to destroy. In addition, FDA alleged that undercover buys by FDA in April 1990 and March 1991 and another inspection of Enzymatic Therapy provided further evidence that, despite the firm's knowledge of serious injuries to customers following use of its products and without regard to FDA's warnings, it continued to promote and distribute unapproved and misbranded drugs.
In May 1991, FDA asked the Department of Justice to initiate injunction proceedings against Terrence J. Lemerond, Enzyme Therapeutics, Inc., BioTherapeutics, Ltd. (a corporation Lemerond founded to market his products to professionals), Bay Natural Foods (owned by Lemerond), Lem's Contract Printing, Inc., which printed materials promoting the products, and Bradley Lemerond (Terrence Lemerond's son and owner of Lem's Contract Printing).
In November 1992, the government and the defendants signed a consent decree of injunction prohibiting the defendants from manufacturing, packing, processing, distributing, selling, promoting, labeling, or advertising its unapproved products, unless and until FDA approves new drug applications or investigational exemptions for the products. In addition, the decree stipulated the defendants must: