ACTION
Final Rule; Response To Objections.
SUMMARY
The Food and Drug Administration (FDA or we) is responding to objections we received on the final rule that amended the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except in meat and poultry. After reviewing the objections to the final rule, we have concluded that they do not provide a basis for modifying or revoking the regulation. We are also confirming the effective date of May 21, 2014, for the final rule.
TABLE OF CONTENTS
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DATES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
II. Objections and Requests for a Hearing
III. Analysis of Objection
IV. Summary and Conclusion
DATES:
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The effective date of the final rule published on May 21, 2014 (79 FR 29078), is confirmed: May 21, 2014.
FOR FURTHER INFORMATION CONTACT:
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Felicia M. Ellison, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1264.
SUPPLEMENTARY INFORMATION:
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I. Background
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In the Federal Register of July 21, 2009 (74 FR 35871), we announced that a food additive petition (FAP 9A4778), had been filed by Ajinomoto Co., Inc., c/o Ajinomoto Corporate Services LLC, 1120 Connecticut Ave. NW., suite 1010, Washington, DC 20036. The petitionproposed to amend the food additive regulations in part 172, Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172), to provide for the safe use of advantame as a non-nutritive sweetener in tabletop applications and powdered beverage mixes. Subsequently, in a letter dated August 24, 2012, the petitioner informed us that FAP 9A4778 had been transferred from Ajinomoto Corporate Services LLC to Ajinomoto North America, Inc., One Parker Plaza, 400 Kelby St., Fort Lee, NJ 07024.
In an amended document published in the Federal Register of October 26, 2012 (77 FR 65340), we announced that Ajinomoto Co., Inc., c/o Ajinomoto North America, Inc., One Parker Plaza, 400 Kelby St., Fort Lee, NJ 07024, had amended its food additive petition to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except in meat and poultry.
In response to FAP 9A4778, we issued a final rule in the Federal Register on May 21, 2014 (79 FR 29078), permitting the safe use of advantame as a non-nutritive sweetener and flavor in foods generally, except in meat and poultry. This regulation is codified at § 172.803. We based our decision on data contained in the petition and in our files. In the preamble to the final rule (79 FR 29078 at 29079-29084), we outlined the basis for our decision and stated that objections to the final rule and requests for a hearing were due within 30 days of the publication date (i.e., by June 20, 2014).
II. Objections and Requests for a Hearing
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Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, “specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections.”
Under 21 CFR 171.110, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA‘s regulations. Under § 12.22(a), each objection must meet the following conditions: (1) Must be submitted on or before the 30th day after the date of publication of the final rule; (2) must be separately numbered; (3) must specify with particularity the provision of the regulation or proposed order objected to; (4) must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and (5) must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection.
Following publication of the final rule permitting the use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry, we received 12 submissions with objections to the rule within the 30-day objection period. The majority of these submissions were letters expressing concern regarding one or more of the following issues: (1) Labeling of products containing advantame, and (2) advantame being mistaken for aspartame. A few of the letters also expressed general opposition to the final rule, or objected to the rule based on adverse effects believed to have been caused by aspartame, and not advantame. None of these letters requested a hearing, nor provided evidence in support of any of these objections that could be considered factual information (§ 12.22(a)(5)). Therefore, these objections do not justify the modification or revocation of the regulation. We will not discuss these submissions further.
There was one submission that raised a specific objection. The letter was from the Natural Resources Defense Council (NRDC) (letter to Docket No. FDA-2009-F-0303, June 20, 2014). The letter from NRDC did not request a hearing on their objection. Therefore, NRDC has waived its right to a hearing on their objection (see § 12.22(a)(4)). The only remaining question under § 12.24(a) is whether NRDC‘s objection, and the information submitted in support of the objection, establish that the regulation authorizing the use of advantame should be modified or revoked. As discussed in detail in section III, we have concluded that NRDC has not established a basis for modification or revocation of the regulation authorizing the use of advantame.
III. Analysis of Objection
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The objection raised by NRDC asserts that FDA did not comply with section 409 of the FD&C Act in our evaluation of the advantame petition because, they claim, we did not conduct a fair evaluation of the data before the Agency as required by section 409(c)(3) of the FD&C Act and did not consider the relevant safety factors as required by section 409(c)(5). Specifically, NRDC states that advantame and the sweetener aspartame are structurally related and that FDA has stated that “advantame actually contains a small amount of aspartame.” NRDC asserts that when we were considering potential effects of advantame, we considered the health effects of aspartame but did not consider the potential impacts of advantame on the hypothalamus despite having evidence that aspartame significantly altered that part of the brain. In support of their claim, NRDC cites five animal studies that they state are in FDA‘s possession and indicate aspartame af
