China: Model Supplement Regs after U.S., Association Advises

August 6, 2014

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China should adopt a structure-function claims system similar to what exists in the United States, USCHPA says.

As China’s Food and Drug Administration redrafts its food safety law, one group is advising that the country emulate U.S. dietary supplement regulations, including the country’s structure-function claims framework.

China is looking to move away from its current “blue hat” pre-registration system and to a notification-based process-much like the notification process that exists in the United States under the Dietary Supplement Health and Education Act (DSHEA). However, even with this notification process in place in China, product formulas (excluding common, single-ingredient vitamins and minerals already approved in China) and ingredients new to the Chinese market will still need to go through blue hat registration, which can take up to three years and hundreds of thousands of dollars to complete, says the U.S.-China Health Products Association (USCHPA), which serves as a liaison between the United States’ and China’s health products industries.

Last week, USCHPA submitted official comments to China’s National People’s Congress on Articles 65 and 66 of the new draft of China’s food safety law. Below are some of USCHPA’s key recommendations.

Eliminate Redundancy

USCHPA advises that China move away from a product-based registration mindset that requires each new product-regardless of similar, already approved ingredients-to obtain unique registration. China also requires that ingredients undergo rigorous and expensive testing procedures each time a product is registered with China’s FDA, regardless of whether an ingredient has already been tested prior and is known to be safe.

“This is redundant and adds time and fees to the registration process, as well as adds unnecessary work to the staff at China’s FDA,” UNCHPA wrote. “If an ingredient has already been established to have a certain function and is safe for human consumption, it should not have to undergo testing each time a company wants to register it.”

Adopt Structure-Function Claims

China’s FDA currently retains a list of 27 approved functional claims for products that companies can use only after completing a lengthy testing process that USCHPA says includes animal and sometimes human testing, “similar to the approval process for drugs,” it wrote.

Instead, USCHPA advises that China’s FDA expand its functional claims list, calling the current list of 27 approved claims “too restrictive.” “For example, the ingredients glucosamine and chondroitin are supported by years of solid scientific research from a variety of international sources to benefit joint health, but ‘joint health’ is not an approved claim,” USCHPA wrote.

China should adopt a structure-function claims system similar to what exists in the United States under which companies are able to claim that dietary supplement ingredients support structures or functions of the human body-and not that they treat or cure disease-USCHPA says. This would allow companies to describe what their products are designed to do and, at the same time, clarify that health products are not drugs. “Many consumers still believe that health food products are a type of medicine,” the association wrote.

Additionally, once an ingredient is approved, it should be eligible for use in a wide range of products and in a range of ingredient combinations, without requiring re-certification. Currently, that is not the case. “For example, omega-3 fatty acids such as EPA and DHA, as well as a list of 21 probiotic strains, are all approved as food ingredients. However, these ingredients are not currently allowed to be sold in tablets, capsules, or soft gel capsules unless they receive a ‘blue hat’ registration from China’s FDA,” USCHPA wrote. Requiring additional registration is, again, “redundant” and resource draining, the association says.

Don’t Call Supplements “Health Food”

China classifies supplements as “health food,” but USCHPA says this designation is too broad. “[It] can encompass many products, such as dietary supplements, yogurt, beverages, certain Traditional Chinese Medicines, and many packaged foods.”

“This has led to confusion among consumers, industry, and government to what exactly is in a health food,” the association wrote. The association suggests using the term dietary supplement as per the definition used in the United States: “a product taken by mouth that contains ‘dietary ingredients’ intended to supplement the diet.”

No Animal Testing

USCHPA also advises that China do away with its requirement that ingredients utilizing a functional claim undergo animal testing. “The practice of testing dietary supplements on animals is not practiced in the U.S. or EU,” USCHPA wrote. “It is unnecessary, as dietary supplements have been well researched and studied over the years.”

The association notes that China is already ending animal testing for cosmetics and suggests it do the same for supplements.

Promote Fair Trade

Up to 70% of raw materials U.S. supplement manufacturers use stem from China, whose exports to the United States equate to billions of dollars annually. Under FDA’s Bioterrorism Act of 2002, Chinese exporters must register their facilities and notify FDA of shipments to the United States-a process that is free and pain-free, USCHPA says. But, the story is not the same for imported products.

“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. Restructuring China’s current regulatory system to one of notification will allow both the U.S. and China to benefit by creating a more balanced exchange of goods,” USCHPA wrote.

Read USCHPA’s full comments here.