By Elizabeth Breezer
Two factors guarantee the long-term stability of the weight loss category:

1) Market: About 30 percent of the adult population in the Untied States is overweight, and

2) Mindset: U.S. consumers worship svelte, young fit people.

Balancing consumer demand for weight loss aids, however, is a regulatory and medical community that remains skeptical of the safety and efficacy of these products. Nicholas Hall & Co. forecasts that the OTC market will continue to grow over the next several years, although consumer preferences for products will continue to shift.

Capsules / Tablets

Fortunately, OTC diet aids with well-established safety records did not suffer too much from the REDUX and Phen-Fen fallout. However, a five-year study of side effects caused by phenylpropanolamine will conclude in 1999 and may indicate the need for new warning labels on the products. In the meantime, Dexatrim, which contains phenylpropanolamine, did very well last year with an advertising budget of $15.3 million.

The majority of leading brands in the category are dietary supplemements. Although label claims about how dietary supplements affect the structure/function of the human body are protected by the Dietary Supplement Health and Education Act, the Food and Drug Administration would like very much to establish stricter protocols. In fact, it has exercised its authority to remove unsubstantiated claims from labels with increasing vigor.

Therefore, we can suggest that marketers who have or are conducting research to support the safety and efficacy of their dietary supplements will benefit from consumers' interest in natural alternatives, and less reputable marketers may face the wrath of a frustrated FDA.

Elizabeth Beezer is a regional vice president, North America, for Nicholas Hall & Co., which publishes OTC update, a monthly journal tracking the OTC markets in the U.S. and Canada. She can be reached at (215) 402-0344: Fax (215) 402-0343: ebeezernhc@aol.com

*Drug Store News Vol. 20 No. 20 1988-12-14

Obesity Therapeutics

Current world market for prescription anti-obesity drugs is worth approximately $400 mil., but the market for weight-loss drugs is potentially enormous. Americans spend $33 bil./yr for weight -loss products.

The prevalence of obesity is increasing at an alarming rate. Today, at least 100 million people are obese, and tens of millions more are overweight. Since these figures seem inexorably destined to grow, the World Health Organization (WHO) and the Untied States Institute of Medicine (IOM) are calling the situation "an epidemic of obesity." The paradox is that millions of people are actively trying to lose weight. For example, in the United States, 40.1% of women and 23.2% of men are tempting to lose weight at any one time. In the process, Americans spend $33 billion/year for weight loss products (including diet foods and soft drinks, artificial sweeteners, and diet books) and services (including fitness clubs and weight loss programs). Even so, one out of four American adults is now obese compared to one out of five in 1980.

All of these factors suggest that the emerging market for weight-loss drugs could be worth billions of dollars, but it is also apparent that there are formidable barriers to a larger market. One barrier is that sloth and gluttony are the roots of obesity; as a consequence, some physicians remain reluctant to treat obese patients with pharmacotherapy. Another barrier is managed care companies unwillingness to reimburse for weight-loss drugs. This unwillingness is fueled by lack of data indicating who will respond to specific pharmacotherapies and which patients need short-term versus long-term pharmacotherapy. A third potential barrier is the imposition of restrictions by regulatory bodies on the use of pharmacotherapy for obesity. This may occur if there is evidence of widespread abuse or misuse.

Since 1970, the NCHS has periodically measured total dietary intake, fat intake, and other health indices in the civilian non-institutionalized population. These studies known as the National Health and Nutrition Examination Surveys (NHAMES), provide estimates of changes in nutrition and health status over time. Compared to NHAMES II (1976 and 1980), NHAMES III (1988 and 1994) showed: Daily calorie consumption climbed 100kcal to 300 kcal for adolescents and adults. Total caloric intake increased from 2,000 kcal to 2,150 kcal. Absolute fat intake rose from 81 grams per day to 83 grams per day.

A number of additional wight-loss agents are being developed and could enter this market in the near future. Roche's Orlistat (Xenical) blocks the absorption of up to 30% of dietary fat. Early reports indicate that it is significantly more effective for weight loss than placebo, but flatulence and stetorrhea reported in some subjects could limit its market acceptance. In May 1997 and FDA advisory panel recommended approval of Xenical for U.S. marketing. Knoll's sibutramine (Meridia) is a beta-phenethylamine that appears to block reuptake of both serotonin and norepinephrine, much like the combination of fenfluramine and phentermine. It received an approvable letter from the FDA advisory committee in November 1996. Still, some are concerned because data showed the drug raised blood pressure 2 mmHg to 3 mmHg in some patients and up to 10mmHg in a few patients. Further back in the pipeline are beta-3 adrenergic receptor antagonists that appear to increase thermogenesis. Some of these compounds are in Phae II clinical trials. Other novel agents include inhibitors of lipid absorption, dopamine agonists, antagonists of neuropeptide Y, glucagon-like peptide and galanin.

The current world market for prescription anti-obesity drugs is worth approximately $400 million. But the market for weight-loss drugs is potentially enormous. Millions of people are obese and millions more are overweight. However, for pharmaceutical agents to become first-line treatments, physicians, managed care organizations, and regulatory agencies must be convinced that they reduce comorbidities cost-effectively.

The pharmaceutical industry will need to educate physicians on the merits of pharmaceutical intervention in cases of obesity. A significant amount of time and effort will probably be required to accomplish this, because physicians have learned that obesity is a psychological and nutritional problem. Accessing the managed care organizations will also be a significant challenge. Even as more members of the medical community recognize that obesity is a disease, managed care companies have not yet changed their treatment policies. These organizations do not reimburse patients for pharmacotherapy in this area unless there is a compelling reason documented by a physician. Many do have weight loss programs, but they focus on dieting , exercise and behavior modification. Convincing regulatory authorities to approve pharmacotherapies for long-term use should also be a challenge. The door has been opened with approval of dexfenfluramine, but weight-loss drugs still undergo closer scrutiny than other classes of drugs. One reason is historical: the first generation of reducing drugs was composed of amphetamines, and abuse and misuse of those drugs became widespread. That prompted a crackdown by regulatory agencies, stricter standards for approval and use, and widespread mistrust of all anti-obesity medications.

*Medical & Healthcare Marketplace Guide 1997-01-00

As the fate of ephedra in dietary supplements remains unresolved, the weight-loss category has turned schizophrenic, with some companies continuing to use ephedra as a primary ingredient in weight-loss products and others turning their attention to newer options. The most popular category spans both sides, playing off the enormously popular diet prescription drug Phentermine-Fenfluramine (Phen/fen). While this drug has FDA approval for short-term use in dieting, it recently has come under fire for its possible connection to heart-valve damage. First out of the gate as a replacement to the pharmaceutical was Herbal Phen-Fen, produced by the diet-control service company Nutri-System of Horsham, Pa. Herbal Phen-Fen, which retails at $20 or more for a one month supply, features a combination of St. John's Wort and ephedra.

Diet Phen, a product from Source Naturals, was introduced to retailers in mid June and supported by floorstands, single sheet literature, shelf talkers and co-op advertising. It combines St. John's Wort with low levels of ephedra alkoloids. According to LaVonne Whitley, marketing director for Source Naturals in Scotts Valley, CA., the inclusion of ephedra was crucial. :We have looked at 20 clinical studies that show ephedra plays a key role in weight loss", she says. "In the first three months, we've sold 3,000 floorstands. People are coming back for the product, and we're receiving consumer testimonials".

With 100 million Americans overweight, natural products retailers again are in a unique position to educate consumers about alternatives that could help them lead healthier lives.

*By Michele Picozzi 1997 Issue of Natural Foods Merchandiser

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