- Docket Number:
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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Fairness Act (P.L. 104-121). This guidance document restates in plain language the legal requirements set forth in the current regulation for the reference amount customarily consumed of baking powder, baking soda and pectin. This is a Level 2 guidance document published for immediate implementation in accordance with FDA's good guidance practices (21 CFR 10.115). The regulation is binding and has the force and effect of law. However, this guidance document represents the agency's current thinking on this subject and does not, itself, create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
The Food and Drug Administration (FDA) issued a final rule, published in the Federal Register of March 16, 1999 (64 FR 12887), in response to a petition from Church Dwight Co., Inc. on behalf of Arm & Hammer. FDA received no comments to the proposed rule, which was published in the Federal Register of November 18, 1997 (62 FR 61476). In the final rule, FDA amended its nutrition labeling regulations by:
- Changing the reference amount customarily consumed per eating occasion (reference amount) for the product category "Baking powder, baking soda, pectin" from 1 gram (g) to 0.6 g (the weight of 1/8 teaspoon (tsp) of baking powder and baking soda, and close to the weight of 1/8 tsp pectin) (21 CFR 101.12(b));
- Including 1/8 teaspoon (tsp) as an additional allowable household measure (21 CFR 101.9(b)(5)(i)); and
- Reorganizing 21 CFR 101.9(b)(5)(i) to simplify the options for teaspoon and tablespoon measures and to improve clarity.
These changes will result in serving sizes on product labels that more accurately reflect the amounts of these products that are customarily consumed. Also, manufacturers will be able to use 1/8 tsp as a serving size because it is a common household measure that is available to consumers.
QUESTIONS AND ANSWERS
|QUESTION:||How will changing the reference amount from 1 g to 0.6 g affect the labeling on my product?|
|ANSWER:||Changing the reference amount may affect your labeling because the reference amount is used as the basis for the serving size. The serving size for baking powder, baking soda, and pectin is the household measure that is closest to the reference amount followed in parentheses by the metric equivalent. For many baking powder, baking soda, and pectin products, the serving size is currently listed as "1/4 tsp (__ g)." However, if you weigh 1/8 tsp and 1/4 tsp of your product, and if 0.6 g is closer to 1/8 than to 1/4, then you will need to change the serving size to "1/8 tsp (__g)."|
|QUESTION:||How do I determine the serving size of my product?|
|ANSWER:||Complete the following steps to determine the serving size of your product:
|QUESTION:||May I use the new 1/8 teaspoon household measure as a serving size for products other than baking powder, baking soda, and pectin?|
|ANSWER:||Yes, if appropriate, all common household measures listed in 21 CFR 101.9(b)(5)(i) can be used as a serving size. For example, powdered cream has a reference amount of 2 g. If you weigh 1/8 tsp and 1/4 tsp of a powdered cream product, and if 2 g is closer to 1/8 tsp than to 1/4 tsp, then the serving size for the powdered cream would be declared as "1/8 tsp (__ g)."|
|QUESTION:||When must I begin relabeling my product?|
|ANSWER:||The new regulation requires that you label all nonexempt products with the new serving size and other information on or after January 1, 2002. You may choose to relabel your products voluntarily before this date (i.e., any time after April 15, 1999).|
This document was issued in July 2001.
For more recent information, see Food Labeling and Nutrition.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1955.