Basic requirements for Chinese Medicine to pass FDA certification and approval
In order to enter the US market, drugs must apply for approval, registration of manufacturers, product registration, pre-sale approval and other relevant procedures and procedures in accordance with the type of products and the relevant provisions of the US FDA, in order to comply with the provisions of the FDA.
Dietary supplements are not food additives
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the definition of dietary supplements. Dietary supplements are "contained". Dietary components "; Of oral products. What these products contain Dietary components "; These include: vitamins, minerals, herbs or other plants, amino acids, and substances such as enzymes, organs, tissues, glands, and metabolites. Dietary supplements can also be extracted or concentrated, and can be made into tablets, capsules, soft gel and other forms. It can be seen that in addition to the usual food in the United States, dietary supplements are also food.
According to the above law, China's health food and herbal (or Chinese herbal) products can enter the U.S. market as dietary supplements.
Security
Dietary supplements fall within FDA's regulatory jurisdiction if FDA produces evidence that dietary supplements exist. Obvious or excessive risk of disease or harm. Or contains" Toxic and hazardous substances that may cause harm to health "; Such products will be detained.
New dietary ingredients
" New dietary Ingredients "; A dietary ingredient first marketed in the United States after October 15, 1994. Before a new dietary ingredient can be marketed, the manufacturer must provide sufficient information to the FDA within 75 days prior to marketing to demonstrate that "the Food and Drug Administration (FDA) is not required." There is no obvious or excessive risk of disease or harm from this ingredient. .
Structure/Function Statement
Allow truthful, not misleading, statements on the label of dietary supplements that describe the role of nutrients or other dietary ingredients in supporting human health. For example, calcium helps build strong bones; Ginger AIDS in digestion and absorption. These statements are deemed" Structure function" Statement or" Vegetative branch Statement.
Structure/function claims do not require FDA prior evaluation, but manufacturers must:
1, to provide scientific and real basis for the structural function statement;
2. Report the structure/function claim on the dietary supplement product label to the FDA within 30 days after the dietary supplement is marketed.
3. In some cases, it is required to include the following non-commitment statement in the label:
" The FDA has not yet reviewed the claims. This product is not intended to diagnose or prevent any disease. "
Health Statement
A health claim indicates the relationship between an edible substance and a health condition. For example, calcium may reduce the risk of osteoporosis. Health claims must be filed with the FDA 120 days before the dietary supplement is marketed and approved by the FDA for use on product labels.
Tags
Dietary supplement labels must comply with all current FDA labeling regulations. This means that labels must list the name and content of each dietary ingredient; The product must be clearly identified on the label as" DietarySupplement" ; If it is a plant-based dietary supplement, specify which part of the plant it comes from. Dietary supplement labels must indicate forms of SupplementFacts corresponding to the product. If this dietary supplement claims to meet an official standard (such as USP), it must meet that standard.
Importantly, the FDA requires labels to be in English, but can also be bilingual (e.g., Chinese and English), but must correspond one to one.
Seven, Good Manufacturing practices
The FDA requires all dietary supplements to be manufactured in accordance with FDA GMP regulations. Currently, the FDA is establishing specific GMP regulations for dietary supplements. Until then, dietary supplements can be manufactured in accordance with the GMP regulations for foods.
Law of the United States
FDA has jurisdiction over raw materials (i.e., dietary ingredients), the composition, manufacture, labeling, and import and sale of dietary supplement products manufactured in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and regulations issued by FDA to enforce this Act. These laws establish a number of definitions associated with them, such as:" Dietary supplement" " New dietary Ingredients "; " Tag" " Health claim" The FDA uses these definitions and standards, including safety and labeling requirements, to determine whether a product is substandard or counterfeit under FFDCA Section 402 and 403, and therefore to refuse clearance and sale in the United States. These definitions and standards are more specific, complex [FS:PAGE], and strict than the various profiles above.
LabelReview and submission of application documents to FDA
The FDA does not approve labels, but requires manufacturers, distributors, or importers of dietary ingredients/dietary supplements to comply with FDA labeling regulations. Since the various regulations of dietary supplements in the United States, including labeling regulations, are extremely strict and complex, it is best for China's health food companies to entrust famous FDA regulatory experts or senior consultants to review and modify the content and format of mandatory and voluntary information that must be marked on their product labels, and according to the regulatory requirements of the United States FDA. Submit new dietary ingredients, structural and functional claims, health claims and other relevant declaration documents to the US FDA for approval or filing within the prescribed time to ensure that Chinese health food as a dietary supplement passes customs smoothly and enters the US market.
