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Hot-selling Products and Regulatory Changes in the U.S. Dietary Supplement Market

The United States is the world's largest dietary supplement market. According to statistics, the annual growth rate of the US dietary supplement industry remains at around 7%-8%. Based on the observation of the US market, this article lists the hot-selling products of US dietary supplements and sorts out the changes in relevant US regulations in recent years.

Currently, the United States is the world’s largest dietary supplement market. According to statistics, the annual growth rate of the US dietary supplement industry remains at around 7%-8%. As consumers’ health awareness and the market mature day by day, the demand for dietary supplements is also escalating. The dietary supplement market in the United States is showing a trend of segmentation and individualization. Some companies have thousands of product lines, and products of the same category can be selected with different dosages to meet the dietary supplement needs of different groups of people. For example, vitamin D products have different dosages of 400IU, 1000IU, 2000IU, and 5000IU. In order to win the market, companies continue to increase R&D investment, develop new products, research new technologies, and bloom innovative activities.

China’s nutrition and health market is also in a period of rapid development. In 2017, China’s import and export of nutritional and health food reached US$3.558 billion, an increase of 12.21% year-on-year, a record high, and an annual growth rate of 10%. The import and export value of nutrition and health products between China and the United States was 693 million U.S. dollars, of which the import value was 440 million U.S. dollars and the export value was 253 million U.S. dollars.

1. Market hot product analysis

Organic, green, natural, and healthy are the major trends in the development of the US dietary supplement market. Vitamins, minerals, and fish oil products are long-selling products. Brand companies generally have such products, such as Now, Nature factors, Natural Made, and other companies. Products containing probiotics, magnesium, turmeric, wolfberry, plant protein, and sports nutrition are currently hot products in the market. The combination of functional raw materials and daily diet is also the development trend of health products, such as aloe yogurt, vegetable protein meal replacement powder, wolfberry food, coconut oil and so on. The way of eating is not limited to capsules, tablets, etc., but more attention is paid to taste, and it is made into various dosage forms such as soft sweets, healthy drinks, solid drinks, and liquid drinks that are easy to accept.

1.1 Probiotics are everlasting.

In recent years, the probiotics market has been rapidly developed and popularized globally. In 2017, the global market for probiotic products (including probiotic supplements and probiotic yogurt) was approximately US$36 billion. The probiotic supplement market has become one of the fastest growing health food segments.

The type and number of strains are the key to the effect of probiotic products. For example, probiotics containing the BB536 strain can be used for traveling or traveling on business, and products containing Lactobacillus and Bacillus can relieve irritable bowel syndrome. There are also products for improving immunity and digestive system. To meet the individual needs of the population, many companies have launched different formula products for men, women, children, and weight management groups, such as launching products containing 15, 18, or 24 strains, containing 50, 150, 300, 500, 100 billion, and other different strains.

From the product point of view, Garden of Life, which has been quite successful in the field of probiotics, has launched a variety of probiotic products. Its probiotic product Primal Defense contains Bacillus subtilis, Lactobacillus, and Bifidobacterium strains that are easy to store at room temperature. There is also a full range of RAW probiotics, which have launched products for men, women, and children. In addition, some products have more specific functions for prostate and urinary tract infections. Childlife launched a probiotic for children’s respiratory tract. Solaray launched a probiotic product specifically for women, containing 24 strains of L. plantarum, L. paracasei, B. bifidum, and short bifidum. B. breve, L. delbreeckii, L. rhamnosus, L. fermentum, etc. Most of the strains are available strains released in China.

Prebiotics are also the current hot spot. Prebiotics are soluble dietary fiber, which can promote the growth of beneficial bacteria in the intestines and inhibit the growth of harmful bacteria, thereby regulating the intestinal flora and promoting the health of the body. Besides, prebiotics can reach the large intestine directly without being digested and absorbed by the intestines, such as fructooligosaccharides (FOS) and galactooligosaccharides (GOS). While supplementing with probiotics, supplementing with prebiotics will improve most people’s constipation problems. Youtheory has launched probiotics and prebiotics formula products, as well as probiotics and fruit powder, mixed and matched products.

1.2 Sports products stand out.

Sports nutrition products in the United States are relatively mature, and sports products are very rich, including sports drinks, sports meal replacements, sports nutrition, and weight management. At present, many companies have introduced plant protein powder, the source of which is the protein extracted from plants. For example, protein powder containing more than a dozen types of protein extracted from peas, quinoa, brown rice, etc. can be used as a dietary supplement for fast-paced people, people who work out, people who lose weight, and vegetarians. For example, the RAW slimming plant protein powder launched by Garden of Life has a variety of flavors and is a high-protein product that can control weight. Now, another giant of dietary supplements also launched a series of organic protein powders.

Medium-chain triglyceride (MCT OIL) is also a product popular among enterprises. MCT OIL is a fat found in natural coconut oil and palm kernel oil. It is easier and faster to digest than other types of fats. MCT OIL is easily absorbed from the gastrointestinal tract and is rapidly metabolized by the liver. It promotes fat production instead of storing fat. Numerous studies have shown that using alternative MCT OIL in a healthy diet can help support healthy weight and body composition. Companies such as Now, Garden of Life, and Nature’s Way have all launched related products. Besides, magnesium products are also the latest products launched by major companies. Magnesium can support heart health and is beneficial to muscle function and nervous system. For example, Life-flo Division launched PURE MAGNESIUM, which aims to provide strong nutritional support for normal and healthy muscle function. All in all, the sports nutrition market has great potential.

1.3 Combine healthy elements with food.

For consumers, healthy and delicious products are the ultimate goal. Therefore, many dietary supplement companies combine healthy elements with food to achieve the purpose of maintaining good health while also enjoying delicious food, such as sea buckthorn oil, wolfberry beverage, aloe yogurt, manuka honey, vitamin gummy, turmeric products, etc. In terms of dosage form, making soft candy, etc. is a more acceptable dosage form.

2. The latest changes in U.S. dietary supplement regulations.

U.S. dietary supplement regulations have always been the focus of attention. Recently, the U.S. Food and Drug Administration (referred to as FDA) held a meeting or issued guidance documents on U.S. dietary supplement regulations.

2.1 FDA holds a meeting on the list of dietary ingredients.

On March 10, 2018, the FDA held a public meeting to discuss the pre-DSHEA list of dietary ingredients under the Dietary Supplement Health and Education Act. The information and evidence to be submitted were discussed at the meeting to prove that the dietary ingredients were sold in the United States before October 15, 1994. In addition to the pre-DSHEA list, the FDA has strengthened the management of ingredients through the implementation of new dietary ingredients (hereinafter referred to as “NDI”) regulations. New dietary ingredients refer to dietary ingredients that were not marketed in the United States before October 15, 1994. In August 2016, the U.S. FDA issued a revised draft of the NDI filing guidelines on its official website, stipulating that by Part 413(a)(2) of the U.S. Federal Food, Drug and Cosmetic Act, manufacturers or distributors must review the new dietary ingredients to be used. Submit data to the FDA 75 days before the market for a strong preparation case.

2.2 New regulations on food nutrition labeling will be implemented soon.

In May 2016, the United States promulgated the “New Regulations on the Labeling of American Food Nutritional Ingredients”, which will be formally implemented in 2019. This is the first major change in food nutrition labeling in the United States since 1990. In addition to the nutrition label that must be indicated, food manufacturers can also choose to label their products with scientifically proven health claims. A health statement can describe the ingredients in a food and its ability to reduce the risk of related diseases. Food nutrition labeling aims to provide consumers with healthy dietary information, help them develop healthy eating habits, and urge food manufacturers to produce healthier foods. The “New Regulations” require that all commercially available food packaging be implemented under the new standards before July 2019. The newly revised content of the “New Regulations” includes declarations from label design, adding footnotes, adding nutritional content items, adjusting vitamins and trace elements, and removing “fat calories”. Recently, the FDA has issued 5 guidance documents regarding the new nutrition labeling regulations. Companies that export to the United States should pay attention to the changes in this regulation.

2.3 Issue guidance documents for GRAS.

In November 2017, the FDA issued a guidance document for the U.S. FDA’s Generally Recognized as Safe (GRAS) indicators. GRAS is a certification that is generally considered safe for human and veterinary foods. In addition, the FDA has issued a guidance document describing the best practices for holding GRAS group meetings

2.4 FSMA implementation timetable

The “Food Safety Modernization Act” (FDA Food Safety Modernization Act referred to as FSMA) describes the hazard analysis and risk prevention and control of human food. The FDA stipulates that different companies need to analyze the hazards in the production or business products and make risk prevention and control within a time limit. Micro companies must be completed by September 17, 2018, small companies must be completed by September 18, 2017, and other companies must be completed by September 19, 2016.

Regarding the rectification and reform to prevent deliberate adulteration in the provisions, the FDA stipulates that micro-enterprises should be completed by June 26, 2021, small companies should be completed by June 27, 2020, and other companies should be completed by June 26, 2019. The factory’s rectification of the sanitary transportation of human and veterinary foods will be completed by small companies before April 6, 2018, and other companies will be completed by April 6, 2017. The Food Safety Modernization Act is also a regulation that has a greater impact on products exported to the U.S. market and requires the attention of companies.

2.5 Foreign Supplier Verification Project (FSVPS)

The FDA proposed the Foreign Supplier Verification Program (FSVPS) that provides food for humans and animals. The foreign supplier verification program (FSVPS) requirements for dietary supplements in FSMA are not dominant, but there are still some application requirements. All companies engaged in the import of dietary nutritional supplements or the production, packaging, and processing of dietary nutritional supplements, as well as the companies that produce and process for these companies, must comply with the requirements of the GMP regulations for dietary supplements.

2.6 FDA warning letter

The FDA issued warning letters to four companies that sell foods and dietary supplements containing cannabidiol (CBD). The warning letter stated that the FDA does not consider CBD as a dietary supplement ingredient. CBD ingredients were a hot spot in the US market in 2017. Cosmetics and dietary supplement companies have developed many related products.

According to statistics, nearly 30% of FDA warning letters are issued to food or dietary supplement companies, 19% of which violate GMP regulations, and 10% are about product claims. Also, there are 11 warning letters that cosmetics claim the effects of the medicine.

3. Conclusion

The nutrition and health industry is full of vitality and vitality for development. Organic, green, natural, and healthy are the major trends in the development of the nutrition and health market in the United States. Besides, Chinese elements are also the focus of the development of American companies. Currently, products made from Chinese raw materials such as wolfberry, ganoderma, sea buckthorn, and turmeric are also attracting attention in the US market. Many international brands favor China’s huge consumer group and strong consumer demand, and they are very concerned about the Chinese market. However, some international brands are currently playing a leading role in China’s domestic health market.

How far is the road for Chinese products from raw materials to finished products and then to brands? With the increase in consumer awareness of Chinese consumers, consumers have higher requirements for product quality. Learn from experience to go further. Chinese companies need to pay close attention to product quality, conduct more technology research and development, and establish brand development awareness to remain invincible in the wave of competition.

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