FDA – Sodium Reduction – Comment Period Extension for Draft Guidance to Industry for Voluntarily Reducing Sodium

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The FDA is extending the two comment periods for the Draft Guidance to Industry for Voluntarily Reducing Sodium.

  • The comment period for issues primarily related to the draft short-term (2-year) sodium reduction targets will end on October 17, 2016.
  • The comment period for issues primarily related to the draft long-term (10-year) sodium reduction targets will end on December 2, 2016.

The comment period for the draft sodium guidance opened on June 2, 2016. That notice originally provided a 90-day comment period requesting comments on Issues 1 to 4 (or issues mainly related to the 2-year draft targets) by August 31, 2016 and a 150-day comment period for Issues 5 to 8 (mainly on the 10-year targets) by October 31, 2016.

The FDA received eight requests from industry trade associations to extend both comment periods to provide a total of 180 days for comment on the short- and long-term targets and three requests from consumer and public health organizations for the comment period regarding the short-term targets to remain unchanged.

For more information:

Federal Register Notice: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods

(Source: FDA website)

New Rules of Registration and Filing of Food Supplements in China

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Today I publish an excellent new article from our food contributor from China: regulatory specialist and former food law advisor for the Food and Drug Administration of Beijing Kun Hou. Hopefully it will be the first of a new series about food supplements Chinese market and regulations.

The food supplements market in China has become a diamond mine and its market value is estimated to have reached RMB 1 trillion in 2015 and it’s still growing with a continuous 20% pace annually regardless of the dim GDP growth in China. The 12th Five-year Food Industry Development Plan issued by the National Development and Reform Commission has lifted the food supplements manufacturing business to a national strategy yet the market maturity and consumer consciousness are still to be developed and nurtured.

I myself handled dozens of cases when I was in FDA of Beijing. Many senior citizens in Beijing aged 60 to 75 filed reports concerning food supplements violations, food fraud, false propaganda and other problems on a daily basis. The number of people who feel they have been deceived of the quality increases every day, so as the market value, which shows exactly how strong the market is. Seniors aged over 60 in Beijing get up early to attend meetings held in some hotel at 5 am. Of course they are lured and just curious to see what the offer is at the very beginning. It all ends up with them paying a great sum of money for some food supplements which claim to be healthy or even cancer-preventing yet of no functional values. When they go back home and several days later they start to realize that what they bought is not what they want. They go to FDA with a receipt that provides limited clue and FDA can do ‘nothing’ because they think it’s a guerrilla war they can never win. Those who sell food supplements in China like PERFECT and INFINITUS mostly among friends and relatives are still disliked by people around them. What’s more intriguing is that so many people still cry in their heart for high-quality food supplements which can earn their fundamental trust with a grandeur brand image. So the affluent ask their friends or children to buy it in a foreign country and carry with them overseas. The environment pollution and the food crisis have further implanted a distrust in people’s mind which will need decades to be uprooted.

A Few Tips on the Regulation

The Regulation on the Registration and Filing of Food Supplements in China has just come into force on 1st July 2016.

Food supplements first imported into China mainland excluding those vitamins and minerals food supplements shall be registered by CFDA. By first imported, it means food supplement produced by the same manufacturer from the same country using the same formula. Any food supplement which does not fulfill the three conditions simultaneously shall be deemed food supplements first imported into China mainland and thus needs to be registered. For vitamins and minerals food supplements, filing is required instead of registration. Both the registration and filing shall be initiated by the manufacturer itself. Difference however exists between the two process. Registration shall be conducted by a resident representative in China or an agent located in China. Such requirement does not apply to filing, which means the manufacturer can do this all by himself.

Here I will give a brief introduction on the filing of food supplements and I will leave the registration in a subsequent article which will also feature some comparison between the FS regulations of China and EU&UK.

Basic Requirements

(1)The nutrients of vitamins and minerals shall fall within the category of Ingredients Catalogue of Food Supplements;

(2)The product formula, the name and usage of the raw and supplementary ingredients, efficacy, manufacturing technique, etc shall be in conformity to Chinese laws, regulations, compulsory standards and the technical requirements of Ingredients Catalogue of Food Supplements;

Required Filing Materials

(1) Material of the product formula including the name and usage of the raw and supplementary ingredient, manufacturing technique and quality standard; when it becomes necessary, more materials have to be submitted to demonstrate the provisions according to which the raw material is being used, specifications concerning which part of the raw ingredient has been used, inspection certificate and variety identification;

(2) Introduction to the manufacturing process including production diagram and specification, the critical controlling point and illustration;

(3) Material of the assessment for the safety and nutrition function appraisal including the test material for the ingredients, products excluded by the Ingredients Catalogue of Food Supplements and appraisal material of human consumption; test report of the effective composition or primary composition, hygiene, steadiness, bacteria identification and toxicity; test report of stimulant, prohibited medicine component,etc;

(4) The type, name and relevant standards of the package material that directly contact the food;

(5) Template of the product label and instructions; search material proving that the general name of the product does not contradict the name of a registered drug;

(6) Filing form and undertaking paper of the authenticity of the materials submitted;

(7) Copy of the registration certificate of the company who initiates the filing;

(8) Materials of the technical requirements for the products;

(9) Full-item inspection report issued by a legally qualified institution;

(10) Other materials showing the safety and nutrition function of the products;

(11) Witness statement issued by competent government authorities or legal service providers showing that the applicant is the legal manufacturer the marketed food supplement;

(12) Witness letter issued by competent government authorities showing that the product has been in circulation for at least one year or safety report about the sales of the product and human consumption;

(13) Technical regulations or standards of the country/region where the product has been manufactured or of the international organization;

(14) The actual version of the package, label and instruction of the product in the country where it has been manufactured and circulated;

(15) Registration certificate or business license if the application is been conducted by a resident representative in China or an agent located in China.

The saddest thing in China is the power of law does not always exercise as what is stated in agreed terms. So never assume something is predictable just because it is written on paper. The government has so many that need further and absolute disclosure. Under most circumstances, what kills a cat is not curiosity, it’s opacity. Nevertheless I still believe openness and sharing will ease the way of food circulation around the world.