Limits Eased on Supplement Claims
WASHINGTON (AP) _ The government says dietary supplements can legally claim to treat a variety of symptoms _ from morning sickness to memory loss _ that are considered common passages of life.
The final regulation issued Wednesday by the Food and Drug Administration surprised consumer advocates, who maintain it weakens patient protections.
The new rule ``allows supplement manufacturers to make claims regarding serious health conditions without any pre-market review by the FDA,″ said Bruce Silverglade of the Center for Science in the Public Interest.
The Grocery Manufacturers of America said the rule ``makes strides which will allow beneficial health information″ to be conveyed to consumers.
At issue are the $6 billion worth of dietary supplements that Americans buy each year _ pills, capsules and teas that do not undergo any government scrutiny for safety or effectiveness before selling.
Federal law allows the products to make truthful claims that they maintain the healthful ``structure or function″ of the body _ but they may not claim to treat diseases.
The question was where to draw the line between what is a real disease and what is just a symptom or annoyance that supplements could legally claim to ease.
The FDA proposed in 1998 that supplements cannot even imply that they diagnose, treat, prevent or cure a disease or definitive disease symptom. But the agency received thousands of letters, from the supplements industry and consumers, complaining that was too strict.
So Wednesday, the FDA relented a little: Supplements will be allowed to claim to help ``common conditions″ associated with ``passages of life″ such as pregnancy, menopause, adolescence and aging _ but clear diseases and serious symptoms are still off-limits.
That means supplements could claim to ease ordinary morning sickness or the common leg swelling of late pregnancy, but not toxemia or other serious pregnancy complications. They could claim to treat teen-age acne and menopausal hot flashes. They could claim to treat muscle pain _ but not joint pain because that’s a classic symptom of arthritis, clearly a disease. They could claim to treat ``mild memory loss associated with aging″ _ but not real dementia.
``It’s a difficult line to draw,″ acknowledged FDA associate policy chief Peggy Dotzel. But ``if it’s a symptom you encounter in the context of stages of everyday life, that’s not a disease.″