USA: market game between supplements and botanicals

The United States is the world's largest consumer market for healthcare products, and also the world's largest demand country for raw materials products The huge industrial demand requires us enterprises to continuously import raw materials from all over the world, including plant-based raw materials For a long time, the United States has been one of the main target markets for the export of Chinese traditional medicine products According to the statistics of China's customs, from 2001 to 2012, the export volume of Chinese traditional medicine products to the United States has increased from US $70 million in 2001 to US $350 million in 2012, with an average annual growth rate of 15.3% The products of traditional Chinese medicine exported to the United States are mainly plant extracts, health products, traditional Chinese medicine and decoction pieces, while the products of traditional Chinese medicine are few Chinese traditional medicine products exported to the United States are mainly used as raw materials for dietary supplements, general food and pharmaceutical products Some Chinese patent medicines can be used as dietary supplements, but there is no approved preparation variety for drug application Unique supplement management system in the United States, the use history of plant products can be pushed forward to the Native American (Indian) era In the first half of the 19th century, botanical drugs were still widely used in the United States In 1820, almost 66% of the medical treatments listed in the United States Pharmacopoeia came from plants By the middle of the 19th century, with the establishment of an American pharmaceutical association dedicated to chemical medicine therapy, the chemical synthetic medicine industry began to develop and grow, and gradually became the leading medicine in the past decades, while the plant products were gradually regarded as outdated products by the American people If plant products are to be used as drugs, they need to be declared according to the registration requirements of chemical drugs, which further speeds up the disappearance of plant products from the U.S market Until 1994, in order to strengthen the management of various health care products and plant products such as vitamins on the market, the U.S government passed the dietary supplement health and Education Act (DSHEA), which prevented the FDA from regulating dietary supplements as "food additives" or "drugs", and clarified the unclear nature of the previous concept of dietary supplements This law also explicitly includes non pharmaceutical plant products into the scope of dietary supplement management In general, FDA will not prevent the product from being listed as a "dietary supplement" as long as it meets the safety issues such as non-toxic, health claims and general label instructions specified by FDA, and does not indicate that the product has the function of preventing or treating diseases From the perspective of management, the fundamental difference between FDA's management of dietary supplements and "food additives" and "drugs" lies in that the latter two must prove the safety of products to FDA, and they can be listed only after FDA's approval Dietary supplements, on the other hand, can be marketed first, requiring the FDA to prove that the product is unsafe and be ordered to withdraw from the market It should be noted that, although DSHEA does not require manufacturers of dietary supplements to register their information with the FDA, according to the public health safety and bioterrorism prevention and Response Act adopted by the U.S Congress in 2002, all manufacturers of dietary supplements must register their information with the FDA before starting production and sales In any case, unlike the "approval system" in many other countries, the "filing system" in the United States gives enterprises more freedom, which is the fundamental reason for the booming development of the American dietary supplement market Due to the high threshold of drug access in the United States, Chinese traditional medicine products exported to the United States for many years are basically circulating in the field of dietary supplements In 2007, FDA issued the final regulation of cGMP for dietary supplements, which requires us dietary supplement manufacturers to comply with cGMP before June 2010 The regulation promotes the market of dietary supplements in the United States, and also has a certain impact on the raw materials of supplements exported to the United States, mainly reflected in the product quality inspection requirements Therefore, Chinese traditional medicine export enterprises should pay attention to it and make corresponding adjustment The booming herbal supplement industry since DSHEA was issued, the American dietary supplement manufacturing industry has been booming, and consumers have a greater choice At the same time, more and more Americans realize the importance of health care due to the increasingly expensive medical expenses and the increasing aging of the population Their enthusiasm for using health care products is growing day by day, which to a certain extent promotes the development of American diet supplement industry and brings more opportunities for the development of Chinese medicine industry According to the statistics of Nutrition Business Journal, the United States has become the world's largest market for health products (including dietary supplements, natural and organic food, functional food, personal and home care products), with a market size of 126.05 billion US dollars in 2011, up 8.5% year on year Among them, the market share of dietary supplements reached 23.8% Despite the weak economic recovery, high unemployment rate and declining consumer enthusiasm in recent years, the U.S dietary supplement market has unexpectedly maintained a long-term and rapid growth momentum According to statistics, from 2001 to 2011, the sales volume of American dietary supplement market has increased from US $18.03 billion in 2001 to US $30 billion in 2011, with an average annual growth rate of 5.2% In the American dietary supplement market, herbal dietary supplements account for a large proportion, accounting for about 17% - 20% of the market share of American dietary supplements This is also an important market for the export of traditional Chinese medicine products, which is of great significance to promote the export trade of traditional Chinese medicine products In recent years, the market growth of herbal dietary supplements in the United States is relatively stable, with an obvious growth trend According to the statistics of Nutrition Business Journal, the sales volume of herbal dietary supplements in the United States has increased from US $4.356 billion in 2001 to US $5.278 billion in 2011, with an average annual growth rate of about 3% In terms of the best-selling varieties, the top three best-selling plant dietary supplement products in the U.S market in 2011 are still Blueberry (Cranberry) extract, saw leaf brown and soybean extract In addition, there are supplements for the prevention or treatment of cardiovascular diseases (such as gingko price leaf extract, resveratrol price alcohol, green tea extract And garlic oil), anti-aging and immunity enhancing supplements (such as ginseng, ginger oil, Echinacea), female supplements (such as black cohosh price, elderberry, aloe price and soybean isoflavone) and sexual health food (such as Epimedium price, yohimbine), are also the best-selling herbal supplement products in the U.S market in recent two years In addition, from the perspective of the prescription ingredients of dietary supplements, from 2005 to 2011, the sales volume of single herbal dietary supplements in the United States increased significantly, while the sales volume of compound herbal dietary supplements did not change much, which was related to the habit that the American people prefer to use single herbal dietary supplements The market of herbal dietary supplements in the United States has a large scale, and the plant extract products in China have become an important source of raw materials in the U.S supplement market For some varieties, such as green tea extract, resveratrol price alcohol, ginkgo price leaf extract, aloe price, etc., China has occupied the advantages of resources, costs, etc Although according to the relevant laws and regulations of the United States, dietary supplements cannot be reimbursed in the national medical insurance of the United States, that is to say, consumers must pay for them at their own expense However, due to the low market access threshold and large market space of health products in the United States, the United States is still an ideal export target market for Chinese traditional medicine products in the long term, and its market capacity is expected to maintain a stable growth 。 In addition, because the history of using as dietary supplement can be used as an important reference when the product is applied for approval of botanical drugs, Chinese traditional medicine enterprises can also choose to market the product as dietary supplement in the United States It should be noted that in recent years, the American people have more rational choice of herbal dietary supplements, which requires that Chinese enterprises should actively understand the market demand, have a specific target, and make a difference.