comparative analysis of food for special medical purpose for infants regulation in china, eu and us

FOOD FOR SPECIAL MEDICAL PURPOSES FOR INFANTS

Comparative Analysis of China, EU, and US Regulations

Jeanne M Hoskin, PhDChemLinked

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© REACH24H CONSULTING GROUP

FSMP BASIS IN GLOBAL, CHINA, EU, AND US LAWCODEX ALIMENTARIUS: Foods for Special Medical Purpose

CHINA: Foods for Special Medical Purpose

EU: Dietary Foods for Special Medical Purpose* Commission Directive 1999/21/EC currently lays down rules for FSMPs Regulation (EU) No 609/2013 on Food for Specific Groups (FSG

Regulation)includes foods for special medical purposes and requires the EC to adopt, through delegated act, specific rules for FSMPs including for infants; this act will replace 1999/21/EC on 20 July 2016 (date of entry into application of the Regulation)

US: The term medical food, is defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))

• For more information on the FSG Regulation see EC Memo• Also see Working Document on adoption of delegated act

http://www.reading.ac.uk/foodlaw/pdf/eu-15001-WG-special-medical-foods.pdf2


http://europa.eu/rapid/press-release_MEMO-13-528_en.htm

http://www.reading.ac.uk/foodlaw/pdf/eu-15001-WG-special-medical-foods.pdf

WEBINAR OUTLINE COMPARE the China, EU and US FSMP regulations and

intent for infants

Current legal status and definition of FSMP Applicable scope Competent authority Registration and/or notification details Promotion, Labeling, and Advertising requirements Issues and trends

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WHAT IS A MEDICAL FOOD (FSMP)? A medical food (FSMP) is formulated for oral or enteral use

under physician supervision “for the special dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

A medical food (FSMP) is “specially formulated” (rather than naturally occurring), and the patient’s distinctive nutritional requirements must be impossible to meet “by the modification of the normal diet alone.”

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DEFINITION OF A FOOD FOR SPECIAL MEDICAL PURPOSE FOR INFANTSCHINA Formula (powder or liquid) that is designed to meet the

needs of infants with special medical conditions such as a particular disorder, disease, or medical condition

Used for exclusive or partial feeding of patients a limited, impaired, or disturbed capacity take, digest, absorb, metabolize or excrete ordinary foodstuffs

Dietary management cannot be achieved by modification of the normal diet or by other foods for particular uses, or by combination of the two

Must be labeled for use under medical supervision

EU and US: same as above except In US, called “exempt infant formula” (see

FDA Exempt Formula list)5


http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm106456.htm

MORE INSIGHT ON THE DEFINITION “patients” not general healthy infant population Given the vital role infant formula has (as sole source of

nutrition first 0-6 months), manufacturing practices, quality control procedures, audit procedures, records and reporting protocols for FSMPs for infants should be at least equivalent to those used for products consumed by healthy infants (FSMPs for infants may, however, deviate in nutrient content due to the specific medical condition for which the FSMP formula is used)

Not all FSMPs for infants are prescribed by doctor, can be available in retail and/or pharmacy

Foods for pregnant and lactating women, foods for diabetics, and foods for vitamin deficiency diseases are NOT FSMPs as their dietary management can be handled by modifications to the normal diet (with or without additions of food supplements and/or fortified foods)

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CHINA The amended Food Safety Law enters into force on October 1,

2015, and is the most stringent Food Safety Law ever passed GB 25596-2010 General Standard for Infant Formula for

Special Medical Purposes Rules (including FSMP registration) apply to domestic and

foreign manufacturers Implementing legislation to amended FSL that applies to

FSMPs for infants will be effective about 1 October 2015 (after public consultation closes on Administrative Measures for Registration of Foods for Special Medical Purposes) A 1-yr grace period is expected to allow industry to comply

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“COMMON” INFANT FORMULA CATEGORIES FOR SPECIAL MEDICAL USE IN CHINA GB 25596-2010 Lactose-free or low lactose (replaced by other carbohydrates

(CHOs) + milk protein) Partially hydrolyzed milk protein formula + lactose-free or low

lactose (replaced by other CHOs) Extensively hydrolyzed milk protein or amino acid formula Premature formulas (higher nutrients than for infant formula) +

medium chain triglycerides Human milk fortifiers for premature infants Amino acid metabolism disorder formula (such as for

phenylketonuria or maple sugar urine disease)

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MEDICAL CONDITIONS NOTED IN GB 25596-2010

Lactose intolerance Milk protein allergy risk* Food protein allergy (diagnosed) Prematurity or low birth weight Amino acid disorder (inborn error of metabolism)*EU and US: Infants with familial or other risk of milk protein allergy

are not FSMP conditions

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OTHER APPLICABLE STANDARDS General Standard for Foods Foods for Special Medical Purposes (GB

25592-2013 and Q&A)* Standard for Good Manufacturing Practice of Foods for Special

Medical Purposes (GB 29923-2013) – applies to foods intended to groups over 12 months

General Standard for the Labeling of Prepackaged Foods for Special Dietary Uses (GB 13432-2013)**

Food Additives (GB 2760-2014) Nutrient Fortifiers (GB 14880-2012) GB Testing Standards/Ingredients (GB 5009) Mycotoxins and Contaminants (GB 2761 - 2012), Food Contact(GB

9685 – 2008 (new draft 2015)), more

*This GB applies to groups over 12 months**This GB applies to Foods for Special Medical Purpose including Infant

Formula for Special Medical Purposes10


SPECIAL LABELING CONSIDERATIONS FOR FSMP

Food not drugs – no claims regarding disease treatment, prevention, cure, or mitigation

Product must be used under medical guidance Product only used for the targeted population Product cannot be used for parenteral nutrition or for

intravenous injection

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LABEL MUST ALSO LIST

Allergens* Other safety information (instructions for use, storage

conditions, shelf life) Warning that improper preparation and use may be hazardous

to health

*EU and US: required allergen labeling but optional in China (nutrition information is suggested to replace allergen listing)

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DRAFT REGISTRATION REQUIREMENTS* Local and foreign manufacturers of FSMP for infants must

apply to CFDA for FSMP registration (before sale) R&D reports, formulation and design basis Production techniques Quality standards and quality management system Labels and samples Test reports and self-inspections of the quality

management system Evidence of R&D capability (production and testing) Evidence of product safety and nutritional adequacy Applicable clinical trials reports (required for sole source

formula) Other materials may also be needed!

* Comments due back to CDFA by 1 October 201513


CHINA FSMP REGISTRATION (PRE-MARKET APPROVAL)

Manufacturers are the owners of FSMP product registrations To obtain and maintain product registrations, local

manufacturers need FSMP manufacturing license issued by CFDA and comply with GMP requirements; foreign manufacturers would be subject to CDFA’s audit of their manufacturing sites outside of China

5 year validity, CFDA of registration package (dossier) is from 135-175 working days

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EU REGISTRATION OF FSMP FOR INFANTSEU: FSMPs must be notified by manufacturers (operators) at market placement to

competent authorities at national level; if forwarded to the EC by MS the submitted dossier could be scientifically evaluated by EFSA in the context of Article 3 of the Regulation (The Commission is empowered to make decisions on the submitted dossier and may ask EFSA for a scientific opinion) Guidance on the scientific and technical guidance for the evaluations of products notified for

FSMP is recently published Highly structured common format dossier by EFSA is recommended to be used by operators

when notifying the MS competent authority of FSMP market placement under the proposed use

Regulation (EU) No 609/2013

US: 90-day notification (90th day before the first processing for commercial or charitable distribution; like for infant formula) is required

see 21CFR21107.50

see Exempt infant formula US FDA guidance

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http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:181:0035:0056:EN:PDF

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr107_main_02.tpl

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm106456.htm

LABELING OF FSMPS FOR INFANTS In general, a deviation in infant formula composition, GMPs, quality

control procedures* and labeling** is permitted to provide the FSMP appropriate for the dietary management of the specific disease, disorder, or medical condition (FSMPs for infants are foods and, therefore, their labeling must comply with all labeling requirements except for those specific requirements from which they are exempt)

*if unusual or difficult technological problems in manufacturing the

FSMP infant formula ensue**if label information, including pictograms and symbols required by

infant formula regulations could lead to inappropriate use of the FSMP product

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REQUIRED ON FSMP LABELING FOR INFANTS In general FSMP labeling for infants should comply with infant formula

labeling requirements (per 100 kcal/kJ etc) Categories (type) of the FSMP and the applicable special medical

condition should be clearly written on the label* If formula is/can be used after 6 months, label should state that auxiliary

food should be taken “Use under guidance of doctor or clinical nutritionist” must be clearly

stated No image of baby or woman, cannot use terms such as “humanized” or

“like human milk” (however they are specially “formulated” by their nature as FSMPs)

Product instructions and use, storage, warning to improper preparation; unsuitability for non-target groups

Prohibited for parenteral nutrition or IV injection No claims relating to disease prevention and/or indications of curative

functions

*for example, “Lactose-free infant formula for infants with lactose intolerance”

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LABELING AND CLAIMS FSMPs for infants are exempt from the labeling requirements for

health claims and nutrient content claims, however their labeling must comply with all food labeling requirements except for those specific requirements from which medical foods are exempt

Label must also include statement of identity (the common or usual name of the

product) net quantity of contents name and place of business of the manufacturer, packer, or

distributor Ingredients listed by their common or regulated name and in

descending order of predominance as required all words, statements, and other information required to appear

on a label or labeling of a medical food must appear with prominence and conspicuousness

principal display panel requirements, the information panel requirements, and the misbranding of food requirements all apply 18


PROMOTION AND ADVERTISING FSMPS FOR INFANTS It is more and more obvious that governments consider the statutory definition of

FSMPs/medical foods to narrowly constrain the types of products that fit within this category of food

These foods are distinguished from the broader category of foods for special dietary use and from foods that make health and nutrition claims by the requirement that they are intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition

They are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick infants are not medical foods

Advertising of food for special medical purposes developed to satisfy the nutritional requirements of infants shall be restricted to publications specializing in baby care and scientific publications

FSMPs for infants should comply with the same restrictions on advertising and promotional practices applicable to infant formula

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INSIGHTAuthorized nutrition and health claims (where permitted for use in foods for infants) to promote foods for special medical purposes for infants would or could be misleading since infants consuming these products are suffering from a disease, disorder, or condition and are, therefore, not part of the general healthy population

Q & AS

Is a gluten-free infant formula a FSMP?

No, gluten is prohibited in regular infant formulas

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Q & AS

Q: Can complete formulas intended for infants who spit up or regurgitate be classified as FSMPs?

A: It is common for infants to spit up after a meal, and infants are not under medical care for spit up. Some infants, however, may have gastroesophageal reflux disease (GERD) and may require medication and behavioral change. Pre-gelatinized starch is believed to assist in spit up and is permitted in regular infant formula

In China pre-gelatinized starch is permitted in FSMPs for infants, but spit up is not a listed special medical condition nor is GERD

It should be noted, however, that FSMPs are based on medical and nutritional research, and as new information comes about, new formulations for special medical use will be developed

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Q & AS

Q: In China partially hydrolyzed milk protein formula for infants with high risk of milk protein allergy is a category of FSMP. Why is this not in the US or EU?

A. Partially hydrolyzed milk protein is not permitted as a protein (nitrogen) source in regular infant formula in China per GB 10765. In EU and US it is, and any label statement relating to reduction of milk protein allergy risk/atopic dermatitis, respectively, is considered a permissible health claim.

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