Via RE: 2014 Draft National Food Safety Standard General Standard for Sports Nutrition Food

Transcription

1 December 19, 2014 Li Bin, Chairperson National Health and Family Planning Commission 国家卫生和计划生育委员会 State Council 14 Zhichun Road Beijing The People s Republic of China (P.R.C.) China Food and Drug Administration (CFDA) 26 Xuanwumen Xidajie District, Beijing The People s Republic of China Via sps@aqsiq.gov.cn RE: 2014 Draft National Food Safety Standard General Standard for Sports Nutrition Food Dear National Health and Family Planning Commission of the People s Republic of China (P.R.C.) and China Food and Drug Administration (CFDA): The Natural Products Association (NPA) is submitting this letter as general comments to the 2014 regulation draft on the National Food Safety Standard of the P.R.C. General Standard for Sports Nutrition Food. The aforementioned revised standard draft (SPS/N/CHN/690)

2 provided for public comment on October 22, 2014, revises the following standards, developed for the category of products in China referred to as sports nutrition food: General Standard for Sports Nutrition Food (GB/T ) Integrated relevant contents in the Sports Nutrition Food Energy Supplement (QB/T ) Sports Nutrition Food Protein Supplement (QB/T ) Sports Nutrition Food Low Energy Food (QB/T ) Sports Nutrition Food Edible Creatine (QB/T ) Sports Nutrition Food Nutrients for Active Men (QB/T ) Relevant contents in the Provisions for Use of Food Additives and Food Nutrition Fortification Substances in Sports Nutritional Foods (Public Notice of the Ministry of Health [2008] No. 18 NPA was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods and natural products. NPA is a non-profit 501(c)(6) association, whose mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, the rights of retailers and suppliers to sell these products, and to promote natural products for healthy lifestyles. We are the oldest and largest trade association in the natural products industry, representing over 2,000 members accounting for almost 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids. Many NPA member companies export finished sports nutrition products to China or import either raw material ingredients for further manufacturing or finished sports nutrition products. These firms are therefore impacted by changes in the 2014 standard revision draft titled National Food Safety Standard of the P.R.C. General Standard for Sports Nutrition Food. Thus, the proposed changes in this draft, pertaining to sports nutrition products and dietary

3 supplements, are of great interest and importance to our members. Thank you for the opportunity to comment. Background The regulatory framework and standards, which govern nutritional supplements and sports nutrition foods in general in China, are important to our industry and to the U.S. consumer. Our suppliers must understand the regulatory requirements in China for exporting specific defined categories of food such as nutritional supplements (dietary supplements), functional (health) foods, and sports nutrition foods. Our U.S. importers of record, who receive Chinese sports nutrition foods in finished form as dietary supplements and raw material ingredients for use in the U.S. dietary supplement market; our retailers, who sell those products on their store shelves; and the U.S. consumer all want access to products with the following general characteristics: Products designed to maintain and improve their health Products containing innovative ingredients coming out of basic science, applied science, and clinical testing laboratories Ingredients and products free of contamination Ingredients and products free of substitutions by economically motivated adulterant (EMA) ingredients Products tested for active pharmaceutical ingredients (API) to ensure quality and safety NPA continues to have concerns that APIs and EMAs continue to be added to food ingredients sourced from China and in products exported from China to the U.S. Even when trace back analysis to determine the source of the harm exonerates the U.S. manufacturer, packer or distributor and implicates the foreign source ingredient or finished product supplier, the harm to the U.S. firm and industry reputation is lasting and sometimes irrevocable. Further damage occurs from lawsuits over adulteration or defects in these products because of U.S. product liability laws.

4 Overview NPA, the oldest, largest and leading trade association in the U.S. for the natural products industry, recognizes the current progress in China toward modernizing its food safety program, bolstering its regulatory framework, redefining of specific categories of food (i.e., nutritional or nutrient supplement), and updating its standards on foods. NPA would like to take this opportunity to comment on the 2014 revised standards for sports nutrition foods involving the following types of dietary supplement products, specifications, nutritional requirements, contaminants and labeling: Energy Supplements (sports nutritional foods with carbohydrates, standardized to at least 65 percent of the total energy, as the major content to quickly and continuously supply energy to the body) Energy Burning Foods and Energy Substitutes (subcategories of Low Energy Foods containing fats and/or protein standardized to at least 25 percent of the total energy, where they are used to promote energy burning and expenditure in sports) Protein and Protein Hydrolysate Supplements (sports nutritional foods with protein and/or protein hydrolysates as the major content to supplement body tissue formation, growth and repair) Technical nutrient content requirements for foods pursuant to supplementing the nutritional needs of athletes participating under various categories of sport Compound Nutritional Supplements (sports nutritional foods with carbohydrates, protein and fat as the major content to satisfy the body s basic needs in sport activities and standardized to contain at least 12 percent energy in protein, less than 30 percent energy as fat, and at least 800 kilojoules (kj) of energy total)

5 Rules for using nutritional fortification substances in sports nutritional foods and suggested daily intakes for nutritional fortification substances NPA recognizes China s efforts to modernize its food safety law and regulatory framework to allow for public notice and comment by national and international stakeholders. The revision of China s standards for sports nutrition foods comes at a very critical time in the industry as the global sports nutrition market projects vast growth for this industry over the next five years. Sports nutrition products are aimed at everyone from casual runners and septuagenarians to elite athletes, and run the gamut to cover endurance, strength training, energy, and post-workout recovery. Due to the global nature of the world economy and China s emergence as a critical supplier of both dietary ingredients and finished sports nutrition foods, which are typically regulated as dietary supplements products in the U.S. and to a lesser degree conventional foods, it is critical for our industry to provide comment, as NPA is the leading voice and advocate trade association for this industry in the U.S. Comments NPA would like to make several comments regarding the 2014 draft standard revision to sports nutrition foods. Table 4 displays mandatory content and suggested content by sport category type. The mandatory content should be expanded in scope to increase the dietary ingredient content of sports nutrition products. For example, products designed for C-type sports should improve bone and joint nutrition/health. The mandatory dietary ingredient listed is calcium while the suggested accompanying dietary ingredient listed is vitamin D. The table listing of calcium as the only single ingredient required to be listed for sports nutrition products designed for joint/bone health sports nutrition products is very narrow in scope in light of numerous ingredients shown to support bone and joint health. Therefore, the mandatory ingredient in that table cell should be expanded to recognize other dietary ingredients with data supporting their efficacy in bone and joint health. For example, vitamin K and dietary phytoestrogens have a long history of use for bone health, and glucosamine and chondroitin are well established for products addressing joint health. There are a wide variety

6 of botanicals studied for joint health such as turmeric (Curcuma longa), ginger (Zingiber officinale), boswellia (Boswellia serrata), and curcuminoids from other botanicals. The list is not meant to be exhaustive, but we would like to see the portfolio of dietary ingredients allowed as mandatory content expanded to include other ingredients to aid with sports-induced fatigue, recovery, energy, bone/joint health, muscle growth, endurance, and strength training. In fact these botanicals would be appropriate for any sport or sports activities that involve active range of motion of joints and therefore appropriate for all four sports categories listed in Table 4. NPA would like to see an expansion of the nutrients, minerals, and other dietary ingredients listed in Table A of the appendix ( Nutritional Fortification Substances ). These listed dietary ingredients are permitted to be used as single or multiple ingredient additives in sports nutritional foods. NPA would like you to consider a broader range of dietary ingredients, including herbs and other botanicals, to add to your list. There are a number of other dietary ingredients not considered in your list of nutritional fortification substances that would enhance recovery of the body post exercise, support hormone levels, increase muscle gains, aid with endurance, reduce body fat, support lean muscle, increase alertness, and enhance handeye coordination. Excluding dietary ingredients by not including them on this list of allowed substances will only serve to limit the innovation of sports nutrition foods. NPA recommends additional testing that Chinese firms must do to ensure their products are safe. NPA applauds your testing for banned substances on the World Anti-Doping Agency list, including sibutramine, which is found in many weight-loss food products and ingredients exported from China to other countries like the U.S. NPA recommends testing for cadmium in addition to lead and total arsenic. Cadmium in food ingredients is becoming a major concern in China, and NPA strongly urges that this metal be tested in sports nutrition foods and all food and supplement products in China. NPA recommends a Good Manufacturing Practices (GMP) standard for these sports nutrition food supplements in China similar to that used in the U.S., as these products are typically regulated as dietary supplements in the U.S. rather than as conventional foods. In the U.S., the federal GMP regulatory standard covering dietary supplements is more rigorous to

7 ensure identity, purity, strength, and composition, safety and quality compared to the GMP standard for conventional foods. The GMP standard adopted for health food and nutritional supplements in China should be administered at the national level rather than at the local level so that it is a true national standard from region to region. The administration of your GMP program should also involve physically inspecting a firm rather than paperwork reviews to determine whether a firm has met the expectations. GMP inspections of facilities are the only way to ensure that ingredients and finished products are manufactured consistently as to identity, purity, strength and composition. Future drafts on the regulatory standard of nutritional supplement products such as sports nutrition food supplements in China should incorporate a comprehensive GMP standard to provide reassurance to U.S. firms sourcing ingredients and importing finished nutritional supplement products from China. The U.S. consumer would like reassurance knowing he or she has access to safe ingredients and supplements from China that are in compliance with a system as rigorous as the U.S. Food and Drug Administration (FDA) dietary supplement GMPs. Conclusion In this document, NPA has outlined our comments on the 2014 revised standard draft for sports nutrition foods. NPA recommends that the current list of mandatory ingredients in various sports nutrition food product types be expanded as well as the list of nutrition fortification substances that can be added to sports nutrition foods. This would allow for a greater diversity of sports nutrition products imported into or exported from China to generate innovation in the types of sports nutrition foods made available to consumers. In addition to expanding the list of dietary ingredients that could be used in combination with one another in sports nutrition food products, NPA supports testing for the metal cadmium in food in China. Cadmium in food has become an increasing concern in China, and we would not like to see consumers in China or abroad consuming cadmium at levels that would affect their health and well-being. NPA also continues to support a serious inspection and testing program at the national level in China to curtail the problem of adulterated Chinese food products exported to the U.S. While NPA recognizes that sports nutrition foods in China will be tested for substances

8 on the World Anti-Doping Agency list of banned ingredients, NPA supports adoption of a strong GMP program. NPA hopes that future amendments to sports nutrition food supplements, health foods and nutritional supplement regulations in China will include the provisions outlined here in these comments. NPA is a signatory to these comments and supports the arguments and conclusions outlined therein. Thank you for this opportunity to comment. We appreciate the opportunity to participate in this important draft process and comment on the regulatory changes and modifications regarding nutritional supplements in China. Respectfully submitted, Corey Hilmas, M.D., Ph.D. Senior Vice President, Scientific & Regulatory Affairs Natural Products Association