The Rise and Fall of Cal-Ban 3000

Stephen Barrett, M.D.

During the 1980s, many companies marketed guar gum tablets or capsules with claims that they can could weight loss. The most aggressive such company was Health Care Products, Inc., of Lutz, Florida, which also did business as Anderson Pharmacals. Their product, Cal-Ban 3000, cost $19.95 for a 3-week supply.

Guar gum is a soluble fiber used in small amounts as a thickener in sauces, desserts, syrups, and various other foods. It has some medically recognized value as a bulk laxative, a cholesterol-lowering agent, and an adjunct to controlling blood sugar levels in certain diabetics. But it has not been proven effective for weight control. No long-term controlled test of guar gum as a weight-control agent had been reported in the scientific literature. Although weight loss had been reported among individuals who took guar gum during studies related to cholesterol and blood sugar control, this finding had not been consistent [1-4].

Dubious Claims

Anderson Pharmacals claimed otherwise. In 1987, one of its widely circulated ads asserted:

The scientific community has at last developed a powerful, fast-acting weight-loss compound that virtually eliminates dieting, eliminates strenuous exercise and, most importantly, eliminates fat, flab and cellulite! The powerful bio-active ingredient . . . works by 'short-circuiting' the fat-building process. "Incredible But True! Cal-Ban 3000 bonds with the food you eat and prevents absorption of a substantial portion of the calories. . . . Your weight loss is automatic! . . . . Eat all you want and still lose weight. . . . Please note: . . . Do not allow yourself to become too thin. If you start to lose weight too rapidly, reduce your tablet intake or skip a day or two." [5]

Cal-Ban's marketers claimed that guar gum causes weight loss by decreasing appetite and blocking the absorption of fat. When taken by mouth, guar gum forms a gel within the stomach that may contribute to a feeling of fullness and may block some nutrients so they are not absorbed. However, it has not been proven that either of these things is enough to produce weight loss consistently. For one thing, many overweight people keep eating even when their stomach signals that it is full. For another, if food absorption is decreased, the individual may eat more to compensate.


Click to read ads

Cal-Ban ads offered an "unconditional 100% money-back guarantee." However, the Better Business Bureau of West Florida gave Health Care Products an "unsatisfactory" business performance record for failing to correct complaints of misrepresentation, nondelivery, and failure to refund money [6]. The National Council Against Health Fraud also received complaints from people in many states who said they had gotten no response to requests for refunds.

Some Cal-Ban ads—including a 1989 2-minute television infomercial—contained testimonials with "before-and-after" photographs of people who appeared to have lost a great deal of weight. I interviewed one such user, a man from Nova Scotia whom the ad said had lost 82 pounds. He told me he had regained about 20 pounds but had been taking Cal-Ban since 1986 and was still pleased with it. American Druggist noted that literature accompanying Cal-Ban offered a $1,000 reward for testimonials and photos demonstrating weight loss when used in the company's advertisements [7].

In 1986, after concluding that Cal-Ban's advertising contained many claims that were deceptive, false, or misleading, the Iowa Attorney General's office sent an investigative demand to Health Care Products,. The company did not respond, but it took two years for the state to file suit [8].

Postal Action

In September 1987, the U.S. Postal Service charged Health Care Products and three of its officers with engaging in a scheme to obtain money through the mail by means of five false representations:

  1. Ingestion of Cal-Ban 3000 will cause significant weight loss in virtually all users.
  2. Ingestion of Cal-Ban 3000 will cause significant weight loss without discipline, calorie restricted diets, or exercise.
  3. Cal-Ban 3000 prevents foods from being converted into stored fat.
  4. The weight loss claims for Cal-Ban 3000 are supported by the results of scientifically sound clinical studies.
  5. An obese person who takes Cal-Ban 3000 may reasonably expect to lose a significant amount of weight while continuing to eat all he or she wants.

A temporary restraining order and preliminary injunction issued during the next two days enabled the Postal Service to begin detaining mail to the company while further proceedings took place [9]. Three months later, a hearing was held before an Administrative Law Judge who concluded that guar gum had no proven benefit for weight-reduction—and that even if it had some value, it certainly couldn't do what the ads claimed. Accordingly, he forbade further use of the claims challenged by the Postal Service [10]. The Postal Service's case was bolstered by a declaration by William R. Ayers, M.D., who had served for five years as medical director of the Georgetown University Diet Management Program. The declaration, based on his extensive review of scientific publications, explained why each of the challenged claims was false [11].

The hearing officer's decision enabled the Postal Service to intercept Cal-Ban orders sent through the mail and return them to their senders. But the company appealed the order [12,13] and continued to run misleading ads in newspapers and magazines and on television. To evade the Postal Services' clutches, orders were solicited through a toll-free number, with payment by credit card or COD, and delivery via United Parcel Service. Cal-Ban was also marketed through pharmacies and health food stores, which were outside of the Postal Service's jurisdiction. However, a few mail-order companies that included Cal-Ban in their catalog still solicited orders with payment through the mail. Based on information supplied by Health Care Products, Dun & Bradstreet reported the company's total 1989 sales as $9.5 million with a net profit of $1.9 million.

FDA Inaction

The weight-loss claims made for Cal-Ban made it a drug subject to regulation by the FDA. But for several years, the agency refused to take action to stop its sale. Guar gum is one of many ingredients covered by the FDA's OTC Drug Review, a process begun during the 1970s to judge the effectiveness of all nonprescription drug ingredients on a class-by-class basis. In 1979, an Advisory Review Panel concluded that guar gum had not been tested enough to determine whether it is effective for weight loss [14]. In 1989, an FDA official informed Congressman Henry A. Waxman (D-CA) that "while guar gum is under the OTC Drug Review . . . and does not present a health hazard, it may be marketed at the manufacturer's discretion." No completion date for the review process had been targeted.

In March 1990, the FDA's position was sharply criticized by Iowa Assistant Attorney General Ray Johnson at a hearing held by the U.S. House of Representatives Subcommittee on Regulation, Business Opportunity and Energy, chaired by Representative Ron Wyden (D-OR). Johnson noted that he and his colleagues have stopped many weight-loss scams from operating within Iowa but seen them continue in other states. Expressing outrage, he stated, "Perpetrators of diet fraud have nothing to fear from the FDA as long as their worthless products are not branded by the FDA as unsafe. . . . The FDA's failure to bring enforcement actions against ineffective weight-loss products has given purveyors of diet fraud full reign for nearly 30 years to violate the Food, Drug, and Cosmetic Act. Resulting consumer losses have been in the billions of dollars." [15]

During the hearing, Wyden's subcommittee released a memo accusing the FDA of "sitting on the sidelines" in the regulation of OTC diet products. After the hearing, FDA staff members claimed the regulations had been tied up because studies involving phenylpropanolamine and benzocaine had not been completed. However, two months later, the agency announced that by the end of 1990 it would propose to ban guar gum along with more than 100 other unproved ingredients used in OTC diet products.

In February 1990, the Iowa Attorney General obtained a consent decree under which Cal-Ban's marketers were ordered to stop selling Cal-Ban in Iowa and to pay $20,000 to cover the state's cost of taking action against them. The company did not admit wrongdoing, but agreed to notify its 1989 customers that the Iowa Attorney General believed its ads were misleading and that a refund would be sent if requested. The company also agreed to pay restitution for 1987 and 1988, using a formula based on the response to the refund offer. Up to $50,000 would be earmarked for the state's Consumer Education Fund, while any excess would be given to an appropriate nonprofit organization [16]. Subsequently, 80% of the 1989 customers asked for a refund, triggering total restitution of $320,000.

Danger Revealed

In March 1990, a gastroenterology journal reported that two men in Indiana, ages 21 and 66, had developed complete obstruction after swallowing four Cal-Ban tablets with water [17]. The obstruction, described as "tenacious," required removal through an endoscope, in one case under general anesthesia. The report noted that when a tablet is placed in water, it swells to 4 or 5 times its original size and has the consistency of putty. Esophageal blockage was also reported with a diet tablet containing guar gum and grapefruit fiber [18].The report attracted considerable media attention, which put further pressure on the FDA. Most notably, CBS-TV's Inside Edition interviewed one of the men whose esophagus had been blocked, demonstrated how Cal-Ban expands in water, and then interviewed a hapless FDA official who said that his agency was unaware that Cal-Ban posed any danger. This statement was remarkable because—as Inside Edition's producer knew—the Indiana cases had been reported to the FDA shortly after discovery, and top FDA enforcement officials were aware of the published article several weeks before the interview took place.

Marketing Ended

Meanwhile, spurred by the evidence of danger, several regulatory agencies took action. Early in July, postal authorities filed suit [19] and obtained a temporary injunction that prohibited sales through the mail and by telephone and directed telephone companies to disconnect the company's toll-free lines [20]. During the same week, the Hillsborough County (Florida) Sheriff filed charges of fraud against three company officials (Elbert Carl Anderson Jr., Ronald Edward Anderson, and Barbara Williams Larkins). [21] In mid-July, the Florida Department of Health and Rehabilitative Services ordered Florida retailers to remove Cal-Ban from their shelves and to stop selling them immediately. The department said it had acted after reviewing complaints involving more than 100 people, at least 50 of whom needed some type of medical intervention. The complaints included esophageal obstruction, gastric obstruction, upper and lower intestinal obstruction, nausea and vomiting [22]. These difficulties probably occurred when the product was taken with small amounts of water. (It is important for individuals consuming large amounts of fiber to consume adequate amounts of water.)

One week later, the FDA sent the company a regulatory letter stating that Cal-Ban was an unapproved new drug and was misbranded and asking that it be recalled immediately [23]. Regulatory letters were also sent to other companies that offered guar-gum weight loss products [24]. The FDA also announced that it had collected reports of at least 17 cases of esophageal obstruction. Hospital stays were required by ten of these people, one of whom died [25]. Shortly afterward, the California Department of Health Services warned consumers not to use Cal-Ban and warned retailers not to sell it. California authorities also embargoed more than 20 million tablets and capsules at a warehouse and manufacturing plant in Anaheim, California [26].

In August 1990, the Florida civil case was settled with a ban on further sales, payment of a $1.3 million penalty. and forfeiture of eight vehicles, and the criminal case was settled with a plea bargain in which the company pled guilty to one count of organized scheme to defraud, paid a $5,000 fine, and pledged never to sell guar gum or Cal-Ban again in the United States. The Postal Service case was settled with an agreement that included payment of a $25,000 penalty and barred the company and its leaders from marketing any guar-gum-based weight-loss product in the United States or using false or misleading advertising in any commercial enterprise. In addition, if the three company officials ever promote another weight-loss aid, the promotional material must make it clear that any weight loss will result from increasing exercise and/or consuming fewer calories [27,28]. Shortly after the agreement was signed, however, the FDA learned that a supply of Cal-Ban was shipped to North Carolina, apparently headed toward a company in Nova Scotia, Canada. The FDA quickly arranged for seizure of the products and obtained a court order authorizing their destruction [29]. In 1992, the FDA banned guar gum as an ingredient in OTC diet products.

What is Needed?

The best way to curb the marketing of dubious mail-order health products is to change the odds of their being profitable. This could be accomplished by passing a federal law giving the Postal Service and the FDA the authority to issue or negotiate large civil penalties against first offenders and enabling the Postal Service to block delivery through other channels besides the U.S. mail. It would also be helpful if a law enabled state attorneys general to obtain federal court injunctions that are binding nationwide. With Cal-Ban, the Postal Service and the Iowa Attorney General acted early in the company's marketing process but could not block sales outside of their respective jurisdictions. If either of the above measures had been available, all sales could have been quickly stopped and many people would have been protected from serious harm.

References

  1. Tuomileto J and others. Effect of guar gum on body weight and serum lipids in hypercholesterolemic females. Acta Medical 208:45-48, 1980
  2. Aro A and others. Effects of guar gum in male subjects with hypercholesterolemia. American Journal of Clinical Nutrition 39:911-916, 1984.
  3. McIvor ME and others. Long-term ingestion of guar gum is not toxic in patients with noninsulin-dependent diabetes mellitus. American Journal of Clinical Nutrition 41:891-894, 1985. (The guar gum was incorporated into granola-type bars.)
  4. Krotkiewski M. Effect of guar gum on body-weight, hunger ratings and metabolism in obese subjects. British Journal of Nutrition 52:97-105, 1984.
  5. National Examiner, July 28, 1989, p 12.
  6. Parsons G. Report on Health Care Products, Inc. The Better Business Bureau of West Florida, May 1989.
  7. Anon. Diet Aid Questioned. American Druggist 201(12):10, 1990.
  8. Petition. In the Iowa District Court for Polk County. Filed in August 1988.
  9. Complaint and order to cease and desist. In the matter of the complaint against Health Care Products, Inc.. et al. P.S. Docket 28/90, recorded Sept 3, 1987.
  10. Initial decision. In the matter of the complaint against Health Care Products, Inc.. et al. P.S. Docket 28/90, May 5, 1988.
  11. Declaration of William R. Ayers, M.D., Aug 14, 1987.
  12. Postal Service decision. In the matter of the complaint against Health Care Products, Inc.. et al. P.S. Docket 28/90, March 3, 1989.
  13. Postal Service decision on motion for reconsideration. In the matter of the complaint against Health Care Products, Inc.. et al. P.S. Docket 28/90, June 27, 1990.
  14. Hayes AH. Weight control drug products for over-the-counter human use; establishment of a monograph. Federal Register 47:8466-8484, 1982.
  15. Johnson R. Testimony. In Deception and fraud in the diet industry, part I, Hearing before the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business, March 26, 1990. Washington D.C.: U.S. Government Printing Office, pp. 47-51.
  16. Consent decree. State of Iowa vs. Health Care Products, Inc., Ronald E. Anderson, Carol Anderson, and Barbara Larkins. Iowa District Court for Polk County C.E. No. 30-17365, Feb 23, 1990.
  17. Morse JMD, Malloy WX. Esophageal obstruction caused by Cal-Ban. Gastroenterology 98:805, 1990.
  18. Gebhard RL, Albrecht J. The diet pill that worked. New England Journal of Medicine 322:702, 1990.
  19. Verified complaint for injunctive relief and for civil penalties. U.S.A. vs. Health Care Products d/b/a Anderson Pharmacals. U.S. District Court, Middle District of Florida, Tampa Division. Case No. 90-839-Civ-T-17C, Julyn 6, 1990.
  20. Amended temporary restraining order. U.S.A. vs. Health Care Products d/b/a Anderson Pharmacals et al. U.S. District Court, Middle District of Florida, Tampa Division. Case No. 90-839-Civ-T-17 (C), July 10, 1990.
  21. Fact sheet. Hillsboro County Sheriff media release, July 1990.
  22. Emergency stop-sale order on Cal-Ban products. Florida Dept. of Health and Rehabilitative Services news release, July 18, 1990.
  23. Chesemore R. Regulatory letter to Barbara W. Larkins, President, Health Care Products, July 25, 1990.
  24. Montague RM. Letter to Stephen Barrett, M.D., Oct 29, 1990.
  25. FDA news release, July 27, 1990.
  26. State health director issues warning on weight-loss product. California Dept. of Health Services news release, July 26, 1990.
  27. Stipulation and settlement agreement. U.S.A. vs. Health Care Products d/b/a Anderson Pharmacals. U.S. District Court, Middle District of Florida, Tampa Division. Case No. 90-839-Civ-T-17C, Aug 24, 1990.
  28. Permanent injunction and order. U.S.A. vs. Health Care Products d/b/a Anderson Pharmacals. U.S. District Court, Middle District of Florida, Tampa Division. Case No. 90-839-Civ-T-17C, Aug 27, 1990.
  29. Order. U.S.A. v. Undetermined Quantities of Cal-Ban 3000. U.S. District Court, Eastern District of North Carolina, Wilmington Division, Case No. 90-126-CIV-7, Sept 17, 1991.

This article was revised on March 22, 2018.

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