How health products compete with the U.S. market in the name of dietary supplements

Business Club October 29th In more than a dozen years, more and more Americans have realized the importance of health care and their enthusiasm for using health supplements has increased. This also made our country's natural health care products exported to the United States more concerned, and the industries related to health care products have also achieved considerable development.

In order to promote the development of China's international trade in health products and help more enterprises to understand the market conditions and access requirements of foreign health products, the “China Handbook for the Quality and Safety of Exported Health Products” was organized by the China Chamber of Commerce for the Import and Export of Medicines and Health Products and compiled by industry experts. The market has introduced a detailed introduction, among which the US market is particularly concerned with the introduction and analysis of a larger space.

DSHEA promotes the development of US supplements

In the United States, health supplements are known as dietary supplements or dietary supplements. They are based primarily on the Dietary Supplement Health and Education Act passed by the United States in October 1994 (Dietary Supplement Health and Education Act). (DSHEA), which aims to develop a new regulatory framework for dietary supplements.

According to DSHEA, the United States amended the Food, Drug, and Cosmetic Act in 1997 to create a new system for the safety and label management of dietary supplements that fundamentally changed the way FDA regulates dietary supplements. DSHEA clarifies the previously unclear attributes of dietary supplements and clearly establishes a subcategory of “dietary supplements” that fall under the broad category of foods. The product is expanded to include a variety of plant products other than vitamins, minerals, and protein (including Plant extracts and related products) and allow multi-component combination dietary supplement products. This provision has an inestimable impact on the dietary supplement manufacturing industry.

DSHEA regulates dietary supplements in terms of ingredients, dosage forms, efficacy, and labeling. Ingredients include: vitamins, minerals, herbs or other plants, amino acids, dietary ingredients (such as enzymes, animal organ tissues, glands, etc.) that can increase dietary intake, or concentrates, metabolites, and structures of the above ingredients. Ingredients, extracts, or a combination of the above; clarify that "cannot be used as a substitute for traditional food, or cannot be used as the sole diet in three meals a day" and may include some newly approved drugs, Antibiotics, or biological products (mainly referring to This type of product that has been legally marketed as a dietary supplement or food in the United States before the FDA approves the listing of the new drug, new antibiotic, or new biological product.

Since the release of DSHEA, the US dietary supplement manufacturing industry has been booming and consumers have more choices. However, as the regulations govern all "natural products" as food or health foods, it is obviously too formal and therefore poses some safety problems.

Different from the "regulations" of medicines

In the United States, the Center's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the major management of the dietary supplement market, including inspection of product functional requirements in product labels, package inserts, and other promotional materials. In the advertising field, the Federal Trade Commission (FTC) is responsible for checking the legality of advertisements for dietary supplements. In addition, there are two agencies associated with dietary supplements: the Office of Dietary Supplements (ODS) and the Dietary Supplements Labeling Council (CDSL) as consultants to FDA dietary supplement management.

The fundamental difference between the FDA's management of dietary supplements and “food additives” and “drugs” is that the latter two must prove the safety of the product to the FDA and be approved for listing by the FDA; dietary supplements can be listed first. When the FDA proves that the product is not safe, it will be ordered to withdraw from the market. Therefore, health products generally do not need to undergo complicated procedures to enter the United States, but the following issues need to be noted:

1. New dietary ingredients

The new dietary ingredient refers to a dietary ingredient that meets the DSHEA dietary ingredient definition and has not been marketed as a dietary supplement in the United States prior to the DSHEA regulations passed on October 15, 1994.

Although dietary supplement Food Ingredients do not require premarket safety assessments like new food ingredients or food ingredients, they must meet relevant safety requirements. If dietary supplements contain new dietary ingredients, manufacturers must submit safety data and application materials to the FDA at least 75 days before the product is expected to be listed. FDA.FDA will reply within 75 days of receiving the notification, inform the number and file . For unnumbered products, FDA informs the customs to detain goods and refuses imports. For security information, the FDA keeps it confidential for 90 days and can be made public after 90 days, unless the information involves trade secrets or other confidential business information.

Since the FDA did not count the DSHEA on October 15th, 1994, as a component of supplements that were previously marketed, there is no authoritative list of dietary supplements. Therefore, the FDA must rely on manufacturers to determine whether the product is classified as a "new component." If it does not belong to the new component, the manufacturer should have information to prove that its composition was on the market before October 15, 1994.

2. General label regulations

Whether or not a product is administered as a dietary supplement depends on whether its label claims to prevent, diagnose and treat the disease and whether the label meets the requirements. It is precisely for this reason that DSHEA and related regulations specify the labeling of dietary supplements.

DSHEA requires that dietary supplement labels must show something: the complete composition data sheet; the recommended intake and daily intake of the major nutrients from the manufacturer; the non-nutritive dietary components contained in the product; Name (if any); manufacturer information, etc.

In addition, there is a product role description on the label, the manufacturer or distributor must notify FDA and provide relevant information within 10 days after the product is listed, but do not need to solicit the FDA's consent in advance; but also on the label to indicate the product's nutritional composition or mention And the product may be related to disease and health, manufacturers or distributors must notify FDA at least 120 days before the product is listed and must obtain its approval.

3. Functional claims

Dietary supplements often have a health-care effect, so the declaration of product features on the label is extremely important for such products. The FDA has strict requirements on product function declarations for dietary supplement labels, and its allowed product function claims have three categories: nutritional content claims, health claims, and structural claims for improved body functions. It must be ensured that the product use and function claims are based on factual evidence, truthful and not misleading.

Among them, the nutritional content claim refers to the information that describes the nutrients in dietary supplements. Often these claims are for dietary ingredients that have a defined daily intake, or they can be advertised as a percentage or contrast description. The nutrient quantitative indicators of these dietary supplements should be filed with the FDA within 30 days of the first listing.

In order to curb the proliferation of counterfeit dietary supplements in the United States, the US FDA announced in January 2009 that new regulations governing dietary supplement products require that all US or foreign companies that market dietary supplements in the United States must be outside their products. The package label identifies the content of the main components of the product and reports to the FDA the composition of the relevant departments. These quantities are determined by the manufacturer and do not require the US FDA's evaluation and approval.

Claims of health describe the relationship between a food or dietary ingredient and health status or reducing the risk of a disease, such as "calcium can reduce the risk of osteoporosis." According to regulations, health claims on nutrient substances and diseases or conditions on the labels of dietary supplements must be approved by the FDA. Although DSHEA has established a reduction of this provision, it must still comply with the requirement that manufacturers must submit to the FDA at least 120 days prior to the launch of the product: a notice of labeling health claims; an authoritative statement to identify the claim It is accurate and based on scientific and technological literature data.

The structure/function claim states that it is related to the description of nutrients and malnutrition diseases. For example, “the lack of vitamin C in the body can cause scurvy,” but the label requires disclosure of the prevalence of the disease in the United States; it can also describe the nutrients contained. How to improve or maintain the body's structural function, or describe the general benefits of ingesting this nutrient to improve human health.

Unlike "health claims," ​​regulations do not require such pre-market FDA approvals, and the manufacturer is responsible for the authenticity and accuracy of the claim. However, if the product label contains such a claim, it must be marked in bold on the label's conspicuous position. "The claim is not FDA-reviewed and the product is not intended to diagnose, treat, or prevent disease." In addition, manufacturers must submit a written notice to the FDA's Office of Nutrition Products within 30 days of the initial listing of the product.

It should be noted that DSHEA strictly prohibits dietary supplements from claiming to have drug effects on labels and advertisements, that is, it is not allowed to claim that products can treat, diagnose, or prevent certain diseases and other drug effects, such as "Ginkgo biloba can prevent Alzheimer's disease" and the like. Because this written statement is not approved by the FDA, it will be treated as an illegal drug.

4. Dietary supplement cGMP

In 2007, the FDA issued the final cGMP regulation for dietary supplements. According to the regulations, companies must evaluate the characteristics, purity, concentration, and composition of their products. If dietary supplements contain contaminants or do not contain the described dietary ingredients, FDA will assume that these products are adulterated or counterfeit.

In order to reduce the impact on food supplements produced by small businesses, the regulation requires that all companies eventually meet the regulations by June 2010. This regulation has a role in promoting the US supplement market, and at the same time it has a certain influence on China's export of supplemental raw materials to the United States, which is mainly reflected in product quality inspection requirements. Therefore, China's health food export enterprises should pay attention and make corresponding adjustments.

In addition, it should be noted that although DSHEA does not require dietary supplement manufacturers to register relevant information with the FDA, all dietary supplement companies are regulated by the Public Health Security and Bioterrorism Prevention Response Act passed by the US Congress in 2002. Must register manufacturing company information with FDA before starting production or sales.

Entering the US Supplement Market

The United States is the world's largest market for health products (including dietary supplements, natural & organic foods, functional foods, personal & home care products). Its market size in 2008 reached US$104 billion, an increase of 8.8% over the same period of last year. The supplement market was US$25.18 billion, an increase of 6.2% year-on-year, accounting for 25.3%. Due to the lower entry threshold set by DSHEA, China's exports of Chinese herbal products are basically managed in accordance with dietary supplements and are mostly used as raw materials for dietary supplements. According to statistics from the China Customs, as of 2009, China’s exports of Chinese medicines to the United States reached US$176 million, an increase of 38.6% year-on-year.

According to the Handbook of Quality and Safety of Exported Health Products, herbal supplements account for a relatively large proportion in the US supplement market and are an important target market for Chinese herbal products or natural products. According to the Nutrition Business Journal, sales of US herbal/plant dietary supplement products reached US$5.03 billion in 2009, an increase of 4.8% year-on-year, accounting for approximately 20% of the U.S. dietary supplement market share. Many Chinese herbal medicines, plant extracts, and natural health products are important supplements. Therefore, it is of great significance to actively enter the US supplement market.

Based on the peculiarities of traditional Chinese medicine products, we must pay attention to the following issues in specific operations:

1. Choose medicinal and peaceful Chinese medicine varieties

Dietary supplements belong to the category of foods in the United States, so it is not advisable to choose Chinese herbal medicines that have strong or highly toxic side effects.

2. Choose non-toxic herbs or varieties that are not endangered

Considered from the perspective of safety, Aconite, Spotted Turtle, Realgar, and Tranquilus are more toxic and should not be sold as dietary supplements; while endangered medicinal materials, it is necessary to go to the import and export management agencies of endangered species of both countries for approval of import and export matters. It's relatively complicated.

3 oral dosage form should be chosen

There are various dosage forms of Chinese medicines such as tablets, capsules, granules, and injections. However, the dietary supplements only allow the oral route of administration. Therefore, Chinese herbal medicines such as injections, suppositories, and eye drops are used for non-oral routes of administration. Should not be listed as dietary supplements.

4. Pay attention to heavy metal content and pesticide residues

The most prominent problem of Chinese herbal medicine products is the problem of pesticide residues, and special attention should be paid to this issue. In addition, some proprietary Chinese medicines produced in China, especially some traditional proprietary Chinese proprietary medicines such as Angong Niuhuang Pills, Liushen Pills, and Zijindan, contain some mineral medicines, and the content of heavy metals such as arsenic and lead often exceeds the FDA limit. the amount. Therefore, for the compound preparations, if some mineral medicines are used in the group, attention should be paid to the problem of excessive heavy metal content, otherwise products will not be able to enter the US market as dietary supplements.

5. Pay attention to the content of the product label

Dietary supplements do not require FDA approval before they are marketed, and their safety and efficacy statements are entirely the responsibility of the manufacturer. Therefore, special attention should be paid to the labeling of dietary supplements. In addition, the label of dietary supplements is also the most important part of FDA's daily supervision and inspection, and manufacturers must pay great attention to it.

According to the Handbook of Quality and Safety of Exported Health Products, the access threshold for health products in the United States is low and the market space is large. This is an ideal export target market for health care products in China. At the same time, due to the history of the use of dietary supplements, it can be used as an important reference in the application for approval of botanicals. Therefore, many Chinese herbal medicine companies prefer to market their products in the United States as dietary supplements. As a whole, the United States is still an important market for the export of health products in China, and it is expected that its market capacity will maintain stable growth.