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Health food FDA certification

Source: ShenZhenTobyTechnologyCo.,LtdPopularity: 449Time: 2016-04-18SMB

According to the relevant provisions of the United States Food Drug and Cosmetics Act < > in the United States Pharmacopoeia (USP-NF) provides the corresponding standards for the use of dietary supplements in raw materials. But it must be noted that the dietary supplement manufacturers in the United States Pharmacopoeia standards are not mandatory. In other words, health food producers can not pay attention to the standard (CP) and to develop related raw material standards. Regulations of food and drug and Cosmetic Act > and 1994 through <, dietary supplements are food. According to this act, dietary supplements management should be no different from ordinary food. Therefore, dietary supplement manufacturers will not be registered in advance of its products FDA or relevant departments must obtain FDA approval to manufacture and sell their products (this point and our country have very big difference).

The United States is the world's largest health food market, the health food varieties are countless. But the United States and China as health food that requires strict examination and approval to be listed, but by the manufacturers to produce and put on the market, all of FDA is only responsible for product safety supervision. Therefore, relatively speaking, in the United States to produce health the food policy is relatively loose. In the United States, like China's health food products are called "dietary supplements" (dietary supplements.1994) in 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 bill, "the dietary supplement health education bill >, which is currently a variety of health food FDA management market on the legal basis.

Dietary supplements are put on the market before, the manufacturer must ensure that its products (including the use of various new materials) on the human body without any harm. The FDA has the right to take action against unsafe dietary supplements (referring to the confiscation of all illegal income of products or to manufacturer imposed heavy penalties, etc.), the manufacturer must ensure that text the text labels for instructions of the authenticity and no any misleading consumers introduced the content.

FDA how to regulate health food in the United States

Due to in American manufacturing and marketing a dietary supplement manufacturers without reporting to FDA products appear side effect situation (including by consumers personal injury or taking products epigenetic disease, etc.), FDA can only through the following means to get listed dietary supplement safety: 1. Consumers (for dietary supplements) complaint report; 2. Sampling (dietary supplement products) labeling or manual content; 3. Access to products (components) reported in the literature; 4. By the FDA inspector in the market random dietary supplement samples, took back to the FDA laboratory were chemical composition analysis.

In the past few years, the United States FDA has seized hundreds of "fake dietary supplements" case, one of the most important and inferior dietary supplement products are mainly chemical drugs added illegally in dietary supplements (which is not allowed in the United States Food Law). For example: FDA inspection found more checks in all States when, in the "slim pills" of every hue (weight loss products) were detected with added ingredient sibutramine, long-term use of high-dose plant-based diet drug ingredient sibutramine may have carcinogenic teratogenic and lead to mental disorders and other serious consequences (now agents in the world have sibutramine shelves). Another issue with American diet the market is a great supplement sales aphrodisiac plant health food law to add like sildenafil (i.e. Viagra), chemical medicine treatment with tadalafil ED (it is said that this approach In the plant world class impotence drug producer commonplace). Illegally added artificial synthesis of androgens such as DHEA in nourishing and strong products, dietary supplements in the United States in recent years is the emergence of new problems. Therefore, dietary supplements on the market of the United States and China's health food is similar to is "problematic".

The dietary supplement products on the U.S. market manufacturers on the market too much, and dietary supplement product quality is uneven in quality so the United States in 2003, FDA proposed a bold plan in the United States dietary supplement industry forced implementation of GMP certification and approval of the U.S. Congress. But in 8 years, this program did not actually because of the strict implementation of GMP transformation. As everyone knows, the manufacturer must pay a lot of money, but most U.S. dietary supplement manufacturers are "(with China's business with a small capital", such as for some similar) is GMP transformation is undoubtedly to the end. Besides, if these small firms (accounting for about America dietary supplement manufacturers 80%) to withdraw from the market, American consumers will face no products to buy the situation. It is said that the final scheme of FDA in the part of the hospital activity points Under the "lobbying and Congress members of the opposition eventually end up with nothing definite. But it is understood currently does some several American dietary supplement manufacturer implementation of the GMP transformation, but the product can not be so prices (because the manufacturers of similar products from other production is not the price). In view of this, in the dietary supplement industry enforced GMP transformation is just a" great dream ", truly to implement a very difficult.

In summary, dietary supplements in the United States is a high degree of prosperity of the industry, and the products are well received by American consumers welcome. According to incomplete statistics, at present on the market of the United States at least tens of thousands of dietary supplement products. It mainly includes the following four categories: vitamin / mineral products; all kinds of plant-based dietary supplement products; animal dietary supplements (such as deep sea fish oil, seal oil, chitosan, chondroitin sulfate, etc.) and other.

In short, dietary supplements in the United States has become a new industry, the annual sales of up to Yierbaiyi $. Understand the existing management methods for dietary supplements in the United States, health food export business of company of our country engaged in certain will benefit.