Why hasn't the FDA evaluated the statements made by vitamin manufacturers?

Question

Vitamin bottles generally state on their lables the health benifits you get if you use the product. Every bottle of vitamins sold in the us has a message high lighted on the lable somewhere, by the food and drug administration. it reads....
" These statements have not been evaluated by the food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease"
Vitamins have been on the shelves many decades now. Why hasen't the FDA evaluated these statements ? If they haven't evaluated them, then how did they come up with the warning that they're not intended to treat, cure, or diagnose disease. Also this message does not appear on any drug bottles. Why does the FDA refuse to evaluate these statements.

Answer 1

The FDA considers vitamins and dietary supplements to be food products, not drugs. Thus, they do not face the same strict regulation and testing that drugs do.

God knows why the FDA made this decision.

Answer 2

As current regulations stand, the FDA is never going to evaluate those products. The label doesn't somehow indicate a waiting list. By putting that warning label on them, all parties involved reduce their risk in case of lawsuits.

By the FDA's definitions, only a drug can "diagnose, treat, cure, or prevent disease." Labeling them as vitamins or dietary supplements means that the FDA doesn't have to test or regulate them as much. They are more concerned with testing high profile prescription drugs.

Before a drug goes to market there have to be many tests to prove its safety and effectiveness. These tests are extremely expensive, and take a long time (That's why new drugs are so expensive in the US). If every calcium supplement wanted to get rid of the label, it would cost the company several million dollars and several years of waiting. They don't feel that this testing is necessary, therefor they label it a supplement, and move on.

If our government was run more effectively, the FDA had a bigger budget to work with, and a few thousand more workers to divvy up resources, then maybe your echinachea and one-a-days would get the regulation they need. Maybe with better management and higher accountability standards there wouldn't be as many injuries and deaths from poorly regulated supplements and "diet aids" every year.

Answer 3

Vitamins are food supplements, so they must be safe, but the FDA has no authority to regulate them in that regard. The regulatory authority of the FDA is simply different for foods than it is for drugs. The same holds true for herbal remedies. They aren't drugs, so the FDA can't control them as if they were, even though people use them as if they were.

Answer 4

1

Answer 5

"Health claims are claims that link the consumption of a food or nutrient with the prevention or reduction in risk of a certain disease. For years health claims were explicitly prohibited by federal regulations because any claim that a substance could affect the course of a disease was considered equivalent to a drug claim. That meant a food carrying a health claim on the label could be considered an unapproved new drug and technically could be seized. The FDA modified its policy, as reflected in the 1993 regulations that allow specific health calims on food packages under certain conditions."

"As of August 2005, the FDA has authorized the following health claims for food labels as meeting this criteria:

- Calcium and osteoporosis
- Sodium and hypertension
- Dietary fat and cancer
- Dietary saturated fat and cholesterol and risk of coronary heart disease
- Fiber-containing grain products, fruits and vegetables and cancer
- Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
- Fruits and vegetables and cancer
- Folate and neural tube defects
- Dietary sugar alcohol and dental caries
- Soluble fiber from certain foods (e.g. whole oats and psyllium seed husk) and risk of coronary heart disease
- Soy protein and risk of coronary heart disease
- Plant sterol/stanol esters and risk of coronary heart disease."

"The Food and Drug Administration Modernization Act (1997) provided a second way for health claims to be approved." "Health claims have to be based on 'authoritative statements' from federal scientific bodies." "Claims under this category include the following:
- Whole grain foods and risk of heart disease and certain cancers
- Potassium and the risk of high blood pressure and stroke."

"In 2002 the FDA allowed another type of health claim to be used on food labels when there is only emerging evidence to suggest a relationship between a substance and a heatlh-related condition. These are known as qualified health claims ..."

Lastly, "health claims on dietary supplements are subject to the same approval process as is required for health claims on conventional food."

Hope this helps you understand the FDA is heavily involved in this issue!

The reference for the above quotes is below. This is an excellent advanced textbook - you may find it useful to read it.