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China Adopts Proposed Notification System for Nutritional Supplements

<p>Observers said the proposal constitutes a less burdensome regulatory model than the expensive and time-consuming &#8220;blue hat" registration requirement that currently applies to health food products.</p>

Chinese regulators released draft regulations governing nutritional supplements, a modest step toward modernizing the health food industry in one of the world’s largest economies.

A proposal from China’s Food and Drug Administration (CFDA) would create a notification or recording system for the introduction of nutritional supplements, according to the U.S.-China Health Products Association (USCHPA). The suggested regulations would be less burdensome than the expensive and time-consuming “blue hat" registration requirement that currently applies to health food products.

CFDA defines nutritional supplements as products that are intended to supplement a deficiency of minerals and vitamins for health care functions, according to an English translation of a proposal (“Administrative Regulations for Nutritional Supplements") provided by USCHPA. Nutritional supplements also play a role “in preventing potent deficiency and reducing the risk of some chronic and degenerative disease," according to the proposal.

The related proposal, “Information Requirement for Nutritional Supplement," governs such varied information as product formulas, manufacturing procedures and product instructions.

Joe Zhou, CEO of TSI Group Ltd. in Shanghai, a global manufacturer of health care products, characterized the proposals as a modest step to lift current restrictions in China’s market.

Around two dozen vitamins and minerals would be subject to the notification or recording system. CFDA has proposed setting forth lower and upper limitations on daily recommended intakes (DRIs). For instance, the lower limit for vitamin C is 30 mg and 500 mg for the upper limit. The limits for calcium are 250 mg (lower) and 1,000 mg (upper).

Some major products that are regulated as dietary supplements in the United States are not included in the proposed regulations. For instance, the Natural Products Association (NPA) pointed out in comments filed with CFDA that herbal botanical ingredients are known as traditional Chinese medicines.

CFDA, however, published a list of other ingredients that would be allowed to make up the products, such as tea green pigment, pineapple fruit powder, olive oil and fruit grape pulp. These other substances could not be listed as main ingredients in the nutritional supplements, USCHPA executive director Jeff Crowther pointed out.

USCHPA and others still have a number of questions concerning how the notification or recording system will precisely work. For instance, how much notification will CFDA require, and/or what criteria needs to be satisfied, before a nutritional supplement could be marketed; and more broadly, how far is the government willing to go to cut red tape? Industry has other concerns too.

Crowther wondered, for instance, whether CFDA would authorize a company to market calcium containing 1,000 mg if there is an expectation that consumers are getting the nutrient from other sources, such as milk. NPA asked CFDA to specify all the ingredients that would be covered under the nutritional supplement regulations and not subject to functional (health) food regulations.

Article 4 of the “Administrative Regulations for Nutritional Supplements" would require that imported nutritional supplements have at least a one-year record of overseas production and marketing. Crowther said that requirement could be problematic if a foreign company, such as a U.S. manufacturer, is selling a product at potency levels that exceed China’s limits.

“They would have to make a brand new supplement just for China that they wouldn’t be able to sell in America because no one is going to buy it," Crowther said in a phone interview with Natural Products INSIDER. “How do they manage to create a marketing and sales record of one year when they can’t sell it?"

Still, Crowther lauded the proposed notification system as a step in the right direction.

China’s blue hat registration system governing health foods is considered to be an onerous process. Applicants must submit a number of materials, including, but not limited to, formulations, labeling information, animal or human studies concerning toxicology and safety, and scientific evidence to substantiate health function claims, according to NPA, the U.S. trade organization founded in 1936.

Around 700 foreign products are registered under the blue hat system, less than one-tenth of the 13,000 domestic registrations, Crowther said. He said it can take two to three years to finalize testing, and it can cost USD $100,000 to register a product.

“The registration process is seen as too costly and time-consuming for most U.S. dietary supplement firms," NPA declared in comments filed Nov. 29 with CFDA. “The registration system is also inherently too slow to react to innovative ingredients that emerge in the global dietary supplement marketplace, leading to major delays in providing consumers with novel ingredients to support and maintain their health."

NPA recommended CFDA adopt a notification system for health foods and new ingredients that resembles the one under the regulatory framework spelled out in U.S. law. Zhou noted CFDA has been much more open-minded in recent years to commentary from the industry and others.

Although CFDA’s proposals have not entirely placated organizations such as USCHPA and NPA, the final regulations may encourage additional foreign investment in the Chinese nutritional supplement market. “Any openness is going to make the foreign companies more willing to spend the money and get into China in this space," Zhou said.

Visit INSIDER’s Regulatory Content Library to learn more about the laws that regulate industry.

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