China’s registration requirement for dietary supplements limits consumers’ health care choices while also restricting the country’s economic growth, says a trade association suggesting China adopt a U.S.-like regulatory framework.

The U.S.-China Health Products Association says in a report on supplement regulation in the country that China’s State Food & Drug Administration is considering reforms to the country’s food product industry regulations.

HPA says relaxing China’s registration requirement for supplements would give consumers access to a wider variety of self-care products, which could help lower overall health care costs in the country, and increase demand for Chinese suppliers’ ingredients from firms that could sell more of their finished products in the country.

“The U.S. would be able to export more products to China, which in turn would increase the export of raw materials from Chinese suppliers to the U.S.,” the trade group asserts in its report announced June 5.

Chinese and other foreign ingredient suppliers can send shipments to U.S. manufacturers through efficient and transparent processes, but China offers a dissimilar system for importing supplement ingredients or other goods – even when the imports are finished products made with ingredients supplied by Chinese firms, HPA CEO Jeff Crowther wrote.

“Although these ingredients originate from China, these same ingredients are not allowed back into China as finished products without going through lengthy and costly registration procedures,” according to the report.

HPA said a registration can take as long as five years of administration procedures, testing and clinical trials and cost $100,000 or more per product, depending on a product’s claim and ingredients. Firms incur additional costs to hire agents to help navigate the process.

A registration must be renewed every five years at additional costs for firms even though a product had been marketed by receiving the SFDA’s initial approval. Moreover, as Chinese regulators slow the introduction of new products there, elsewhere the supplement industry continuously is making available better products due to scientific advancements.

“Because of [SFDA’s] lengthy registration process, dietary supplement companies are unable to introduce new products rapidly or reposition product lines to best suit consumer demands. This results in a significant reduction in the variety of products that offer the latest developments in nutritional health as well as increases retail pricing due to the high costs of registrations,” Crowther stated.

The trade group points out China’s system allowed certain domestic companies to dominate the industry after spending heavily on product registrations in the 1990s. Overall, domestic firms’ registrations dwarf foreign firms’ numbers: Chinese firms received 3,154 registrations from 2010 through 2013, while foreign firms received 56.

Notification Process Retains Agency Authority

HPA suggests China’s SFDA move from a registration to a notification requirement for supplement ingredients, and require notifications only for ingredients, not for every product. Like regulation of the supplement industry in the U.S., China would have authority to remove from the market products that are not dietary ingredients or found to be unsafe.

Recommending use of the U.S. system for introducing new dietary ingredients for supplements could be criticized, though.

The Dietary Supplement Health & Education Act established a relatively straightforward framework of setting Oct. 15, 1994, as the grandfather date for old dietary ingredients – those already available in the food supply – and requiring new dietary ingredients notifications to FDA at least 75 days before a new ingredient is introduced.

However, FDA contends that many products that contain NDIs are launched without notifications filed, and the agency has enforced against no small number of products containing substances that should have been subjects of NDI notifications. On the other hand, the supplement industry widely questioned and objected to FDA’s 2011 draft guidance on NDI notifications and the agency, following a prompt by the industry’s congressional allies, began revising the draft guidance in 2012 with no timetable for completion Also see "FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders" - Pink Sheet, 16 September, 2013..

The association asserts changing the focus of China’s enforcement would make more SFDA officials and other resources available for post-market surveillance of nutritional products.

“Increased surveillance will increase the safety of the industry as well as enhance consumer confidence, which are both currently lacking,” according to the report.

The likelihood of China changing its registration framework for dietary supplements is difficult to gauge with the absence of transparency in the country’s regulatory processes and with government leaders’ authority to make changes with no accountability to industries or consumers.

HPA also recommends China:

scrap plans to reduce the number of structure/function claims allowed from 27 to 18 and instead apply a less-restrictive framework similar to the U.S. approach.
strike a requirement of testing with animals for structure/function claims, which are “unnecessary as dietary supplements have been well researched and studied over the years.”
allow higher potency levels for most vitamins and minerals, in line with current supplement research.

Additionally, while suggesting an easing of SFDA’s regulatory requirements for introducing supplements in China, Crowther said the agency should tighten its definition of dietary supplement to alleviate confusion for consumers and allow the agency to focus more narrowly its enforcement activity.

SFDA’s current category identifier – “health food products” – is “too broad a concept” that “can include anything that is healthy for humans to consume.”

The ambiguous definition leaves room to market the same ingredient in multiple product categories, such as calcium tablets marketed as a food product or OTC drug in addition to a health food product. Similarly, traditional Chinese medicines often are marketed, with regulatory approval indicated on packages, as health food products, Crowther wrote.

He added that “most consumers in China believe that health food products are a type of medicine due to their history of being sold in pharmacies as OTC as well as some unscrupulous companies overstating their functions.”

The report points out China’s health food products industry is the fourth largest behind the U.S., Japan and Europe, with total sales in 2012 of $15.8 billion. “However, the exact figure is hard to determine due to the ambiguities in China’s regulatory system” and the “overall concept of what a health food product actually is,” according to the report.

Crowther set up HPA in 2010 after leaving the Natural Products Association's China office in Beijing, which closed soon after Also see "China Market Veteran Crowther Lobbies For Nutritional Product Regs" - Pink Sheet, 21 March, 2011..

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