The United States of America FDA how to regulate the health food FDA certification

According to the United States of America" food drug and Cosmetic Act" of the relevant provisions, the United States Pharmacopeia ( USP-NF ) is a dietary supplement use in raw materials and provides the corresponding standard. It must be pointed out that, for the dietary supplement manufacturers, the United States Pharmacopoeia in the related standard is not mandatory. In other words, health food manufacturers can ignore these ( USP ) standards and to develop related raw material standard. And through the 1994" food drug and Cosmetic Act" in regulation, dietary supplements to food. According to the bill, dietary supplements should be managed with the ordinary food is. Therefore, dietary supplement manufacturers do not have the product beforehand in the FDA related departments registration, or must obtain the FDA approval before production and sales of its products ( this point and our country have very big difference).
The United States is the world's largest health food market, its health food varieties are countless. But the United States health food and unlike our country needs strict examination and approval to be listed, but by the manufacturer with its own production and market, FDA is only responsible for the supervision of product safety problems. Therefore, relatively speaking, in the United States to produce health food policy is more relaxed. In the United States, like China's health food products are known as" dietary supplements" ( dietary supplements ). In 1994 the United States Congress passed a on 1968 approved the implementation of the" food drug and Cosmetic Act" as the basis and the correction of the new act --" dietary supplement health and Education Act", which is the current FDA management on the market of health food of legal basis.
In dietary supplements on the market before, manufacturers must ensure their products ( including the use of various new materials) on the human body without any harmful. FDA has the right to the safety of dietary supplements to take action ( refers to all the illegal income confiscated products or to impose heavy fines on manufacturers ), the manufacturer must ensure their products on the text labels indication of the authenticity of any misleading presentation of text content.
The United States of America FDA how to regulate the health food
Due to production in the United States and listed dietary supplement manufacturers need not report to FDA product side effects appear situation ( including consumers personal injury or illness, after taking the product ), the United States FDA only through the following means to get listed dietary supplement safety: 1 consumer complaints ( on dietary supplements) report; 2 checks ( dietary supplement ) label or instructions; 3 access products ( components ) of the relevant literature reports; 4 by FDA inspectors in the market selectives examination randomly dietary supplements samples, back to the FDA Laboratory for chemical composition analysis.
In the past few years, the United States FDA has uncovered hundreds of" fake dietary supplements" case, one of the most important and dietary supplement products are mainly in dietary supplements added illegal chemicals ( in the United States Food Law is never allowed). For example: FDA inspector in the nation to spot checks found in the" of every hue, slender pill" ( products ) were detected in add sibutramine components, and long-term use with large doses of sibutramine components of plant weight loss drugs have the potential teratogenic and carcinogenic lead to mental disorders and other serious consequences ( now the song has been in preparation all the countries in the world under the frame ). The United States of America dietary supplements market is another big problem is of great sales aphrodisiac plant health food illegal add like sildenafil ( i.e. Viagra ), tadalafil treatment ED in chemical medicine ( it is said that the practice of various countries in the world of plant and yang-invigorating formulation it is quite common for manufacturers ). In the strong tonic products added illegal synthetic androgens such as DHEA, is the United States of America dietary supplements in recent years and the emergence of new problems. Therefore, the United States market dietary supplements and Chinese health food case similarity, but also the problems"".
Because the United States market dietary supplement manufacturers too much on the market, as well as dietary supplement products quality is uneven, some good and some bad, so the United States of America FDA once in 2003 proposed a bold plan, i.e., dietary supplements in the United States Industry forced the implementation of GMP certification and draw the United States congressional approval. But in 8 years, the program actually does not strictly implement. Because as everyone knows, the implementation of GMP transformation of the manufacturers have to pay a large sum of money, and the United States of America most dietary supplement manufacturers are" business with a small capital" ( with the situation of our country has some similarities, such as the implementation of GMP ) forced reform undoubtedly is to ruin. Besides, if these small firms (about American dietary supplement manufacturers around 80% ) to exit the market entirely, American consumers will face no products can be bought. It is said that FDA this scheme finally in section" lobbyists" lobbying members of Congress opposition eventually settle a matter by leaving it unsettled. But it is understood, there have been a handful of American dietary supplement manufacturers to implement GMP to transform, but the product is not therefore price (because of the manufacturers produce similar products did not rise in price). In view of this, the dietary supplement industry imposed GMP transformation is simply a" great dreams" only, true implementation is very difficult.
To sum up, dietary supplements in the United States is a highly prosperous industries, and products received by American consumers. According to incomplete statistics, at present the United States market at least 10000 kinds of dietary supplement products, mainly includes the following 4 categories: vitamin / mineral products of every hue; the botanical dietary supplement products; animal dietary supplements ( such as deep sea fish oil, seal oil, chitin, chondroitin sulfate, etc.) and other types of.
In short, a dietary supplement in the United States has become a new industry, the annual sales reached $ Yierbaiyi high. Understanding of dietary supplements in the United States current management measures, on China's health food products in the export business of the company would be helpful.