Basic requirements for approval of Chinese medicine through FDA
 

The drug to enter the American market must be in accordance with the types of products and the relevant provisions of United States FDA, to apply for approval, production enterprise registration, product registration, pre-sales approval and other related procedures that comply with the requirements of FDA.
1.         Dietary supplements are not food additives
The dietary supplement definition was established in the dietary supplement health and Education Act (DSHEA) issued in 1994. Dietary supplements are oral products containing dietary ingredients. The dietary ingredients contained in these products are include: Vitamins, minerals, herbs, or other plants, amino acids, and enzymes, organs, tissues, glands and a substance such as a metabolite. Dietary supplements can also be extracts or concentrates; it can be made into tablets, capsules, soft and other forms. Thus, in the United States, except the usual food, dietary supplements also belong to the food.
 
In accordance with the above laws, China's health food and herbal products can be used as dietary supplements to enter the US market.
 
 
2.         Safety
Dietary supplements belonging to FDA regulations jurisdiction, if FDA evidence that dietary supplements are having obvious or excessive illness or danger or the dietary supplements containing the toxic or harmful substances that may cause harm to health, so such products will be detained.
3.         New dietary ingredients
The "new dietary ingredients” refers to a diet that was first introduced in the United States after October 15, 1994. Before the new diet ingredients are come into the market， manufacturers must provide sufficient information to the US FDA within 75 days before the on the market, to prove that there is no obvious or excessive risk of disease.
4.         Structure / function statement
In the dietary supplement label, a true and non misleading statement describing the role of nutrients or other dietary components to supporting human health is allowed. Such as: Calcium helps to strengthen bones; ginger helps digestion and absorption. These statements are referred to as "structural function" statements or "nutritional support" statements.
The structure / function statements do not need to do the prior evaluation by FDA, but manufacturers have to:
a.    Provide a scientific and true basis for structural functional statements;
b.    Declare the supplement products’ structure / function on the label to the FDA dietary within 30 days before the start of the dietary supplement come into the market.
c.     In some cases, the following statement of non acceptance is required in the label:
“The food and drug administration has not yet evaluated this statement. And this product is not needed to diagnose or prevent any disease. "
5.         Health statement
A health statement shows the relationship between diet and health. for example: Calcium can reduce the risk of osteoporosis. Health claims must be declared to the US FDA before 120 days the dietary supplements into the market, and get the licensed by the US FDA for use on the product label.
6.         Label
Dietary supplement labels must comply with all current FDA labeling regulations. This means that the labels must list the names and contents of each dietary ingredient; It must be clearly marked on the label as "Dietary Supplement"; If it's a dietary supplement for plants, what part of the plant also need to claim. Dietary supplement labels must be marked with the corresponding Supplement Facts form of the product. If the dietary supplement claims to be in line with the official standards (e.g., USP), so it must meet this standard.
Importantly, the American FDA requires labels to be in English, bilingual (such as Chinese and English) can also be used, but they must to be one-to-one.
7.         A good production specification
The United States FDA requires all dietary supplements must to be manufactured in accordance with FDA's GMP regulations. Now, FDA is setting up special GMP regulations for dietary supplements, prior to this, dietary supplements can be manufactured in accordance with the food GMP regulations.
8.         The American Law
FDA for raw materials (i.e. diet ingredients) in accordance with the "federal food, drug and Cosmetic Act" (FFDCA) and FDA for the implementation of the law and the production of dietary supplements product composition, manufacture, and label the import and sale of jurisdiction. The law establishes some related definitions, such as: "dietary supplements", "new dietary ingredient", "tag", "health declaration” and standards, including safety and labeling requirements, FDA uses these definitions and criteria to determine a product accordance with the provisions of the FFDCA402 and the 403 section was be the inferior or counterfeit products, and thus refused to the customs clearance and sales in the United states. These definitions and standards are more specific, complex and rigorous than those outlined above.
9.         Label Review and submit documents to FDA
FDA does not approve the labels, but requires manufacturers, distributors or importers’ product label must comply with the requirements of the U.S. FDA labeling regulations. . Because of the regulations of the United States dietary supplements, including labeling regulations very strict and complicated. Therefore, it is better for health food enterprises to entrust famous FDA regulation experts or senior consultants to review and revise the content and format of mandatory and voluntary information that must be indicated on the product label, and according to the American FDA regulations, submit the new dietary ingredients, structure, function declaration, health declaration and other relevant declaration documents to the U.S. FDA for approval or filing at the appointed time, to ensure that the Chinese health food as a dietary supplement are smooth customs clearance, and access to the U.S. market.