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1st Plan
In the first plan, a regulatory strategy, the FDA will work with the federal and other partners to improve the evidence base used by.
FDA to formulate safety and enforcement decisions regarding dietary ingredients and dietary supplements ( evidentiary base).
Those partners include the National Institutes of Health Office of Dietary Supplements and the National Center.
Complementary and Alternative Medicine, and the National Toxicology Program of the Department of Health and Human Services ( National Toxicology Program).
The National Center for Natural Products Research of the University of Mississippi, the National Center for Toxicological Research of the FDA, and other institutions.
2nd Plan
In order to promote the effective implementation of this requirement, the FDA has announced its second plan-a public meeting on November 15, 2004.
which aims to discuss the type of evidence that manufacturers provide to FDA in a new dietary ingredient notification , Quantity and quality, solicit public opinions.
The FDA did not anticipate any immediate changes to its enforcement procedures. According to the FDA’s clarification that a notice must be submitted to the substances
constituting a certain new dietary ingredient, the FDA will continue to communicate with the company.
3nd Plan
The third plan is to seek opinions on the draft guidance document on the quantity, type, and quality of evidence, reflecting the FDA’s obligation to fully implement DSHEA.
According to section 403(r)(6) of the Federal Food.
Dietary Supplements and Cosmetic manufacturer should have proof of a claim Evidence such as structural function claims.
SaturdaySale Although DSHEA’s revised “Federal Food, Drug, and Cosmetic Act” requires proof of such claims, it does not define the term.
The draft guidance document stipulates the flexibility of manufacturers in the precise amount and type of evidence that constitutes substantiation.
4th Plan
Providing a standard for certification may also help protect consumer confidence in these products.
The FDA did not anticipate any immediate changes to its enforcement procedures.
SaturdaySale According to the FDA’s clarification that a notice must be submitted to the substances constituting a certain new dietary ingredient.
FDA will continue to communicate with the company.
In addition, before implementing any next measures, FDA will fully review the opinions it has obtained from public meetings