CRN fights to protect weight loss from disease-state claim
WASHINGTON —The Council for Responsible Nutrition last month delivered a 19-page document to the Food and Drug Administration outlining exactly why food and supplement manufacturers should not be stripped of their ability to make weight-loss claims, in response to a citizen’s petition filed by GlaxoSmithKline and a host of obesity-related consumer associations in April that would define weight loss as a disease-state claim.
At stake is a dietary supplement marketer’s ability to position its product as promoting weight loss at all—supplement manufacturers are prohibited altogether from making disease-state claims, be they substantiated or not, and are instead restricted to making only structure or function claims, where the products improve the health of a structure (for example, joints) or function (digestive health, immune-system health) of the body.
“There are a whole lot of reasons why consumers use weight-loss products,” charged Steve Mister, president and chief executive officer of CRN. “In the practical marketplace, the majority of these consumers are using [diet aids] because they want to shed a few pounds for swimsuit season or they want to look a little better for their high school reunion.… All of those are good reasons to use these products, and they have nothing to do with an underlying motive to reduce the risk of certain kinds of diseases.”
This isn’t a new issue for the FDA, CRN charged. The FDA decided weight loss was an appropriate structure/function claim in 2000, as opposed to treating or curing obesity, which is a disease, the association noted. And there’s nothing in the current citizen’s petition that would suggest overturning that decision.
CRN outlined four arguments against the citizen’s petition:
Consumers don’t pursue weight loss through diet, exercise and supplementation necessarily to manage a disease risk like obesity or such comorbidities as heart disease, osteoarthritis or diabetes, but rather to look or feel good, oftentimes with short-term goals in mind. For those who make that lifestyle change, manage to lose weight and keep it off, improved heart health, joint health or metabolism health are added benefits.
Unlike obesity, simply being overweight has not been established as a validated, modifiable risk factor for, or surrogate endpoint for, disease. “Mere associations of the risk factor with disease risk is insufficient to support a health claim,” CRN noted.
Granting this citizen’s petition would not only affect the marketing of diet aids, but that of any food product for weight loss. And as sweeping an impact as that would have, it may also establish a precedent around which other health-related conditions might be categorized as disease-state claims.
Substantial and adequate oversight is already in place to help corral unsubstantiated or misleading claims around any dietary supplement, including dietary supplement diet aids.
Top five movers in diet aids*| Product | Units sold (in thousands) | % change | $ volume (in millions) |
| Alli | 2,291.8 | 196.2% | $133.3 |
| Hydroxycut | 1,374.1 | 2.7 | 34.5 |
| Mega T | 1,267.4 | –16.8 | 9.0 |
| Applied Nutrition | 775.2 | 14.9 | 6.0 |
| SlimQuick | 704.6 | 45.7 | 16.9 |
| Diet-aid tablets | 14,735.7 | –9.4% | $355.3 |
If the FDA were to define weight loss as a disease-state claim, that wouldn’t pull those products off the market, per se, but it would certainly inhibit their ability to compete with GlaxoSmithKline’s blockbuster over-the-counter diet aid drug Alli as it enters year two on the market, a product that’s currently posting $133.3 million in sales across food, drug and mass (minus Wal-Mart) for the 52 weeks ended July 13, according to Information Resources Inc.
And while that dollar base is almost four times larger than its next-closest diet aid competitor, Hydroxycut, the proof is in the turns. GSK’s Alli moved 1.7 more units off the shelves than Hydroxycut in that period. If successful with its petition, it’s that gap between units sold that may grow larger.