Drugs/Docs #1 Killer yet FDA Takes On Dietary Pill Claims Back to Pauling Cure for Heart Disease

What is Going On?

Why then is the U. S. Government Federal Drug Administration worried about dietary supplements when drugs, over-the-counter medicines and doctors are one of the leading causes of death in the U. S.?

Whose interests are these new FDA proposals really serving? The general public interest, or the interest of drug companies?

Doctors salaries are in the top one percent and growing. Does anybody really think Docs/Drugs are the Leading cause of injury and death by accident?

From AP - FDA Takes On Dietary Pill Claims

WASHINGTON (AP) -- Dietary supplements cannot legally claim to do such things as "prevent cancer" or "lower cholesterol," the government says.

Consumers buy some $5 billion worth of dietary supplements each year -- pills, capsules and teas that are not approved by the Food and Drug Administration as safe and effective before they hit the market.

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. Actual treatments must undergo rigorous scientific study not required for supplements.

The question for dietary supplements was where to draw the line: Some companies argue, for example, that promising to lower cholesterol -- or "maintain healthy cholesterol" -- was not the same as claiming to treat heart disease, even though cholesterol levels are key to heart health.

The FDA proposed Friday to ease the confusion by prohibiting supplements from even implying they can diagnose, treat, prevent or cure a disease or definitive disease symptom.

"Our hope is once this regulation goes final, the industry will see a safe harbor and have an incentive to stay within it," said FDA Deputy Commissioner William Schulz.

The rule would not let supplements claim to:

--Protect against the development of cancer, reduce the pain and stiffness of arthritis or lower cholesterol. Nor can they use such names as "Hepatacure," which implies it cures liver problems.

--Help the body respond to disease, by saying they "support the body's ability to resist infection or fight a virus."

--Substitute for a drug, through a name such as "Herbal Prozac" or claims that they contain aspirin or another well-known drug.

But supplement claims clearly targeted to help a well person stay well would be OK. The FDA said naming a supplement "Cardiohealth," for instance, is legal, as is saying it "supports the immune system," "reduces stress" or "helps maintain cardiovascular function."

Overall, the proposal "will be helpful," said Annette Dickinson of the Council for Responsible Nutrition, which represents supplement-makers.

The industry agrees with many of FDA's examples, she said, "but there will be some gray areas," including the cholesterol question, that companies will discuss during a 120-day public comment period before the FDA finalizes the rule.

But one consumer advocate called the proposal inadequate. Bruce Silverglade of the Center for Science in the Public Interest questioned how letting a supplement advertise that it "promotes regularity" was any different to the average consumer than calling it a laxative -- which is a drug.

AP-NY-04-25-98 0219EDT<

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