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model claims

Polish translation: ilustrujące/przykładowe oświadczenia zdrowote

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:model claims
Polish translation:ilustrujące/przykładowe oświadczenia zdrowote
Entered by: Lidia Lewandowska-Nayar

10:01 Jul 11, 2018
English to Polish translations [PRO]
Bus/Financial - Medical: Pharmaceuticals / farmakologia
English term or phrase: model claims
"MODEL CLAIMS" shall mean final approval by the FDA of Estrasorb as an estrogen hormone replacement therapy prescription product.
Lidia Lewandowska-Nayar
Poland
Local time: 18:57
ilustrujące/przykładowe oświadczenia zdrowote
Explanation:
Model Health Claims
Section 101.80(e) provides examples of statements that meet the requirements to make a health claim about nonpromotion of dental caries. FDA emphasizes that these “model health claims” are illustrative only. These model claims illustrate both the elements of the health claim statement required under § 101.80(c)(2)(i) and some of the optional elements permitted under § 101.80(d). FDA is amending § 101.80 to add isomaltulose as an additional noncariogenic carbohydrate sweetener eligible for the health claim, and is not approving specific wording of claim statements. Manufacturers continue to be free to design their own claim so long as it is consistent with agency regulations.

The model health claim examples in § 101.80(e)(1)(iii) and (iv) and § 101.80(e)(2)(iii) and (iv) are examples of health claim statements for use with D-tagatose-containing foods. FDA is revising these model health claims to change from the specific sugar “tagatose” to “name of a sugar from paragraph (c)(2)(ii)(B) of this section” to be inclusive of either tagatose or isomaltulose, or other noncariogenic sugars that may be added to the rule in the future.

Current § 101.80(e)(1) consists of examples of the full claim, and § 101.80(e)(2) consists of examples of the shortened claim for use on packages with less than 15 square inches of surface area available for labeling.

https://www.federalregister.gov/documents/2007/09/17/E7-1819...

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Note added at 39 mins (2018-07-11 10:40:32 GMT)
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cccccccc
CFR - Code of Federal Regulations Title 21
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 101 -- FOOD LABELING

Subpart E--Specific Requirements for Health Claims

Sec. 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.

2) Specific requirements --(i) Nature of the claim. A health claim relating noncariogenic carbohydrate sweeteners, compared to other carbohydrates, and the nonpromotion of dental caries may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim shall state that frequent between-meal consumption of foods high in sugars and starches can promote tooth decay.

(B) The claim shall state that the noncariogenic carbohydrate sweetener present in the food "does not promote," "may reduce the risk of," "useful [or is useful] in not promoting," or "expressly [or is expressly] for not promoting" dental caries.

(C) In specifying the nutrient, the claim shall state "sugar alcohol," "sugar alcohols," or the name or names of the substances listed in paragraph (c)(2)(ii) of this section, e.g., "sorbitol." D-tagatose may be identified as "tagatose."

etc.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...

--------------------------------------------------
Note added at 41 mins (2018-07-11 10:42:26 GMT)
--------------------------------------------------

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between noncariogenic carbohydrate sweetener-containing foods and dental caries.

(1) Examples of the full claim:

(i) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries.

(ii) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay.

(iii) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries.

(iv) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar in [name of food], unlike other sugars, does not promote tooth decay.

(v) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay.

(2) Example of the shortened claim for small packages:

(i) Does not promote tooth decay.

(ii) May reduce the risk of tooth decay.

(iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar does not promote tooth decay.

(iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar may reduce the risk of tooth decay.
Selected response from:

Frank Szmulowicz, Ph. D.
United States
Local time: 12:57
Grading comment
dzięki
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1ilustrujące/przykładowe oświadczenia zdrowote
Frank Szmulowicz, Ph. D.


  

Answers


35 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
ilustrujące/przykładowe oświadczenia zdrowote


Explanation:
Model Health Claims
Section 101.80(e) provides examples of statements that meet the requirements to make a health claim about nonpromotion of dental caries. FDA emphasizes that these “model health claims” are illustrative only. These model claims illustrate both the elements of the health claim statement required under § 101.80(c)(2)(i) and some of the optional elements permitted under § 101.80(d). FDA is amending § 101.80 to add isomaltulose as an additional noncariogenic carbohydrate sweetener eligible for the health claim, and is not approving specific wording of claim statements. Manufacturers continue to be free to design their own claim so long as it is consistent with agency regulations.

The model health claim examples in § 101.80(e)(1)(iii) and (iv) and § 101.80(e)(2)(iii) and (iv) are examples of health claim statements for use with D-tagatose-containing foods. FDA is revising these model health claims to change from the specific sugar “tagatose” to “name of a sugar from paragraph (c)(2)(ii)(B) of this section” to be inclusive of either tagatose or isomaltulose, or other noncariogenic sugars that may be added to the rule in the future.

Current § 101.80(e)(1) consists of examples of the full claim, and § 101.80(e)(2) consists of examples of the shortened claim for use on packages with less than 15 square inches of surface area available for labeling.

https://www.federalregister.gov/documents/2007/09/17/E7-1819...

--------------------------------------------------
Note added at 39 mins (2018-07-11 10:40:32 GMT)
--------------------------------------------------

cccccccc
CFR - Code of Federal Regulations Title 21
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 101 -- FOOD LABELING

Subpart E--Specific Requirements for Health Claims

Sec. 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.

2) Specific requirements --(i) Nature of the claim. A health claim relating noncariogenic carbohydrate sweeteners, compared to other carbohydrates, and the nonpromotion of dental caries may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:

(A) The claim shall state that frequent between-meal consumption of foods high in sugars and starches can promote tooth decay.

(B) The claim shall state that the noncariogenic carbohydrate sweetener present in the food "does not promote," "may reduce the risk of," "useful [or is useful] in not promoting," or "expressly [or is expressly] for not promoting" dental caries.

(C) In specifying the nutrient, the claim shall state "sugar alcohol," "sugar alcohols," or the name or names of the substances listed in paragraph (c)(2)(ii) of this section, e.g., "sorbitol." D-tagatose may be identified as "tagatose."

etc.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfr...

--------------------------------------------------
Note added at 41 mins (2018-07-11 10:42:26 GMT)
--------------------------------------------------

(e) Model health claim. The following model health claims may be used in food labeling to describe the relationship between noncariogenic carbohydrate sweetener-containing foods and dental caries.

(1) Examples of the full claim:

(i) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries.

(ii) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay.

(iii) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries.

(iv) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar in [name of food], unlike other sugars, does not promote tooth decay.

(v) Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay.

(2) Example of the shortened claim for small packages:

(i) Does not promote tooth decay.

(ii) May reduce the risk of tooth decay.

(iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar does not promote tooth decay.

(iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] sugar may reduce the risk of tooth decay.

Frank Szmulowicz, Ph. D.
United States
Local time: 12:57
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 237
Grading comment
dzięki

Peer comments on this answer (and responses from the answerer)
agree  Marcin Pustkowski: Well done!
29 mins
  -> Dziękuję Marcinie. Serdecznie pozdrawiam.
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