2015-27369. Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA or we) is confirming the effective date of September 22, 2015, for the final rule that appeared in the Federal Register of August 21, 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules.

DATES:

Effective date of final rule published in the Federal Register of August 21, 2015 (80 FR 50762), confirmed: September 22, 2015.

FOR FURTHER INFORMATION CONTACT:

Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 21, 2015 (80 FR 50762), we amended the color additive regulations in § 73.530 Spirulina extract (21 CFR 73.530) to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement tablets and capsules. We also amended the color additive regulations to add § 73.1530 Spirulina extract (21 CFR 73.1530) to provide for the safe use of spirulina extract as a color additive in coating formulations applied to drug tablets and capsules.

We gave interested persons until September 21, 2015, to file objections or requests for a hearing. We received no objections or requests for a hearing on the final rule. Therefore, we find that the effective date of the final rule that published in the Federal Register of August 21, 2015, should be confirmed.

List of Subjects in 21 CFR Part 73

• Color additives
• Cosmetics
• Drugs
• Foods
• Medical devices

Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, we are giving notice that no objections or requests for a hearing were filed in response to the August 21, 2015, final rule. Accordingly, the amendments issued thereby became effective September 22, 2015.

Dated: October 21, 2015.

Susan Bernard,

Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition.