—–Original Message—–
From: Suite1oh1@aol.com
Sent: Friday, March 05, 2004 7:10 PM
To: druginfo@cder.fda.gov
Subject: DrugInfo Comment Form FDA/CDER Site

Comments: I don’t see fluoride supplements, which require a prescription, listed on your approved drugs list. They are prescribed to children to prevent tooth decay. Why aren’t they approved? They aren’t nutritional supplements, so they can’t be excluded.

Is it safe to give children drugs that haven’t been FDA approved?

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Subject: RE: DrugInfo Comment Form FDA/CDER Site
Date: 3/9/2004 3:56:03 PM Eastern Standard Time
From: DRUGINFO@cder.fda.gov
To: Suite1oh1@aol.com

Sodium fluoride has been marketed in the United States since before 1938,when the Food, Drug, and Cosmetic Act (the Act) was enacted. The Act is the basic food and drug law of the United States and is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

With the passage of the Act, an approved New Drug Application (NDA) was required for marketing any new drug product (drug products introduced after 1938), as the regulatory mechanism for ensuring that all new drugs were cleared for safety prior to distribution. An amendment to the Act in 1962 required that, before marketing a drug, a manufacturer also had to provide substantial evidence of effectiveness for
the product’s intended uses.

Drugs on the market prior to enactment of the 1938 law were exempted, or “grandfathered”, and manufacturers were not required to file an NDA. The premise was that all pre-1938 drugs were considered safe, and if the manufacturer did not change the product formulation or indication, then an NDA was not required. However, once a manufacturer made any change to a pre-1938 drug, that drug was considered by the FDA to be a “new drug” and the manufacturer was required to prove that the drug was safe for its intended use.

The FDA is aware of sodium fluoride-containing products in various dosage forms that are currently marketed. At the present time, the FDA is deferring any regulatory action on sodium fluoride products that were marketed prior to 1962 as long as the currently marketed product is identical to the pre-1962 product.

Any prescription sodium fluoride-containing product coming into the marketplace after 1962 that is not identical to the pre-1962 labeling and that has drug claims, is subject to the FDA drug review process prior to marketing. Drug sponsors, generally manufacturers, develop new drugs, from the earliest laboratory discoveries through various phases of animal and human safety testing as well as clinical testing for effectiveness and appropriate dosing.

The FDA reviews data collected during drug testing at two key points: first, at the time the sponsor believes that the drug is ready for human testing and submits an Investigational New Drug Application (IND); and second, at the time the sponsor submits an NDA for approval to market the drug product. Before the FDA will permit testing of a drug in humans (clinical trials), the sponsor must provide us information in an IND demonstrating that the drug is reasonably safe to administer to humans. The sponsor must also provide manufacturing and control data, a detailed plan for clinical trials, and the names and qualifications of the investigators who will be performing the clinical trials.

Not all oral vitamins are prescription drugs. If the preparation contains 1mg or more of folic acid, then it is prescription. They are indicated for a variety of reasons but mainly to maintain normal blood levels and,therefore, prevent a variety of clinical conditions associated with vitamin deficiencies. If a patient is already deficient, then they will need more than the RDA to replete body stores of the deficient vitamin(s). Certain inborn errors of metabolism require treatment with specific vitamins.

Thank you
Bd100
CDER Drug Information
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From: Suite1oh1@aol.com [mailto:Suite1oh1@aol.com]
Sent: Wednesday, March 10, 2004 8:29 AM
To: DRUGINFO@cder.fda.gov
Subject: Re: DrugInfo Comment Form FDA/CDER Site

Thank you for your very detailed answer.

Sodium fluoride supplements weren’t tested as a decay preventative until the
1950’s or 1960’s. The sodium fluoride on the market before 1938 was sold as
a rat poison. Were there any other medicinal reasons for using sodium
fluoride before 1938?

Thank you.
Sally

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Subject: RE: DrugInfo Comment Form FDA/CDER Site
Date: 3/18/2004 1:17:15 PM Eastern Standard Time
From: DRUGINFO@cder.fda.gov
Reply To:
To: Suite1oh1@aol.com

We don’t have information on the medical uses of fluoride before 1938.

Thank you

bd100
CDER Drug Information

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