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Medicine through the FDA approval of the basic requirements for certification
Release Date: [2017/3/30 15:35:43]    Total read [] Times

Traditional Chinese Medicine health care products into the U.S. market as a dietary supplement, must comply with the United States, "Federal Food, Drug, and Cosmetic Act," "dietary supplement Health and Education Act" and the U.S. FDA issued by the law. In order to enter the U.S. market, the range of products must be in accordance with the relevant provisions of the U.S. FDA, for approval, production and business registration, product registration, pre-approval and other related procedures and formalities to comply with the provisions of the FDA.

First, dietary supplements are not food additives

Promulgated in 1994, "Diet Supplement Health and Education Act" (DSHEA), the established definition of dietary supplements. Containing dietary supplements are "food ingredients" of oral products. These products contained in the "food ingredients" include: vitamins, mineral biological, herbs or other plants, amino acids, and enzymes, organ tissues, glands and substances like metabolites. Dietary supplements can also be extracts or concentrates, and can be made into tablets, capsules, soft and other forms. Thus, in addition to the usual food in the United States, the dietary supplement is also a food.

According to the above law, China's health foods and herbs (or herbs) can be used as a dietary supplement products into the U.S. market.

Second, security

Dietary supplements is under the jurisdiction of FDA regulations, if the FDA to produce evidence to prove the existence of dietary supplements, "obvious or excessive risk of pathogenic or harmful" or contain "may cause harm to the health of hazardous substances", then this product will detained.

Third, the new dietary ingredient

"The new dietary ingredient" refers to the October 15, 1994 after the market in the United States for the first time a food ingredient. Before the listing of the new food ingredients, the manufacturer must be listed 75 days before the U.S. FDA to provide sufficient information to prove that "this component is not obvious or excessive risk of pathogenic or harmful."

Fourth, the structure / function claims

In the dietary supplement described on the label allowed nutrients and other dietary components in support of the role of human health and not misleading statement true. For example: Calcium helps bones strong; ginger helps digestion and absorption. These statements were regarded as "structure function" statement or "nutritional support" statement.

Structure / function claims without FDA pre-assessment, but manufacturers must:

1. For the structure function claims provide the basis for scientific and real;

2. Listed in the dietary supplement within 30 days beginning with the U.S. FDA dietary supplement product labels to declare the structure / function statements.

3. In some cases, required to include in the label is not committed to the following statement:

"Food and Drug Administration has not evaluated this statement. This product is not used to diagnose or prevent any disease."

Fifth, health claims

Health claims that food substances and the health status of the relationship. For example: bone calcium can reduce the risk of osteoporosis risk. Dietary supplement health claims must be listed in the 120 days before the return to the U.S. FDA and get permission from the U.S. FDA on the product label use.

VI Tags

Dietary supplement labels must comply with all current FDA labeling regulations. This means that the label must list the name of each diet components and content; must be clearly marked on the label of such products as the "Dietary Supplement"; if a plant food supplements, but also shows from which part of the plant. Dietary supplement product labels must be marked with the appropriate Supplement Facts table. If this dietary supplement claims that meet the official standards (for example, USP), then it must meet this standard.

Importantly, the U.S. FDA requires labeling in English, but also a bilingual (for example: in English), but it must be one correspondence.

Seven, good manufacturing practice

U.S. FDA requires that all dietary supplements regulations in accordance with FDA's GMP manufacturing. FDA is now working for the establishment of a special dietary supplement GMP regulations, before that, a dietary supplement can follow the GMP regulations for food production.

VIII, U.S. law

FDA on raw materials (ie, diet composition), in accordance with "Federal Food, Drug, and Cosmetic Act" (FFDCA) and FDA to implement this law and regulations promulgated by the production of the composition of dietary supplement products, manufacturing, labeling, and import and sale of jurisdiction. These laws establish a number of related definitions, such as: "food supplements" and "new dietary ingredients", "label", "health claims" and standards, including safety and labeling requirements, FDA use of these definitions and standards identify a product in accordance with the provisions of FFDCA402 and 403 or whether the poor quality and counterfeit products, and thus reject its customs clearance and in the U.S.. These definitions and standards of the profile than the more specific, complex [FS: PAGE] complex and stringent.

Nine, Label Review (Label Review) and the filing of documents submitted to U.S. FDA

Not FDA approved labels, but requires dietary composition / dietary supplement manufacturers, distributors, or importers of the product labels must comply with U.S. FDA labeling regulations. Since the U.S. dietary supplement regulations, including labeling regulations very strict and complex, it is the best of health food companies commissioned by well-known experts in FDA regulations or senior consultant must be marked on the label of their products mandatory and voluntary information content and format to review and modify, according to the U.S. FDA regulatory requirements within the prescribed time to submit the new U.S. FDA dietary composition, structure function claims, health claims and other related filings for approval or record, to ensure that our health as diet food supplements smooth customs clearance, access the U.S. market.

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