Center for Food Safety and Applied Nutrition
Constituent Update
FDA Withdraws Draft Guidance on the Applicability of Color Additive Regulations Authorizing the Use of Certain Fruit Juice and Vegetable Juice
May 12, 2017
The Food and Drug Administration is withdrawing a 2016 draft guidance on the use of fruit juice and vegetable juice as color additives based on public comments that raised substantive technical concerns. The concerns include that the guidance promoted practices that may be inconsistent with current industry practices intended to enhance food safety.
Historically, the FDA has responded to industry questions on the use of vegetable juices and fruit juices as color additives on a case-by-case basis. Color additives used in food must be approved for use by the FDA. The FDA has authorized the use of juice from certain fruit and vegetables (21 CFR 73.250 and 21 CFR 73.260, respectively) as color additives in food. The draft guidance was developed to assist industry understanding whether plant-derived color additives meet the specifications in these regulations or require separate approval as color additives. Although the FDA is withdrawing this draft guidance, the regulations authorizing certain plant-derived color additives remain in place and the agency will continue to respond on a case-by-case basis to industry questions on these topics. In addition, the FDA intends to continue evaluating information submitted to its docket and consulting with stakeholders in considering next steps.
Like all color additives in packaged foods, fruit juice and vegetable juice color additives must be declared in the ingredient label statement and must be safe under intended conditions of use. Fruit juice and vegetable juice when used as color additives in food may be declared as “Artificial Color,” “Artificial Color Added,” or “Color Added,” or by an equally informative term that makes clear that a color additive has been used in the food, such as “Colored with Fruit Juice” or “Vegetable Juice Color.”
Previous Update from February 28, 2017
The Food and Drug Administration is reopening the comment period on its draft guidance for industry: fruit juice and vegetable juice as color additives in food for 60 days to allow interested persons additional time to submit comments. The draft guidance, when finalized, will clarify when juices from fruits and vegetables may be used as color additives in food under existing authorizations without additional premarket review and approval from the agency under its color additive petition process.
Interested parties may submit comments by written letter or electronically starting March 1, 2017.
Additional information, including directions for filing comments and the final due date for comments, is available in the Federal Register notice announcing reopening of the comment period.
Original Constituent Update from December 13, 2016
In response to questions from food manufacturers, the U.S. Food and Drug Administration has issued draft guidance to clarify when juices from fruits and vegetables may be used as color additives for foods without additional premarket review and approval from the agency under its color additive petition process.
Color additives must be approved for use by the FDA and must be used only in compliance with the approved uses, specifications, and restrictions set out in FDA regulations. The authorization for the use of fruit and vegetable (21 CFR 73.250 and 21 CFR 73.260, respectively) as color additives in food are limited to the juice from certain fruit and vegetables and under certain conditions. The basis for these color additive regulations is that the fruit or vegetable from which the juice is made has been safely consumed as food. The fact that a plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations.
Manufacturers have asked the FDA about a variety of color additives made from plant materials. For example, in response to these inquiries, the FDA has advised that juice made from purple corn and black carrots can meet the specifications of the vegetable juice color additive regulation. We have also advised that juice made from safflower petal and hibiscus flower do not meet these specifications.
Manufacturers seeking to use plant materials that do not meet the specifications under the fruit and vegetable juice color additive regulations can submit color additive petitions with safety data for the FDA’s review. In response to such petitions, the FDA has authorized color additives that are made from certain plant materials in separate color additive regulations.
Like all color additives in packaged foods, fruit juice and vegetable juice color additives must be declared in the ingredient label statement. Fruit juice and vegetable juice when used as color additives in food may be declared as “Artificial Color,” “Artificial Color Added,” or “Color Added,” or by an equally informative term that makes clear that a color additive has been used in the food, such as “Colored with Fruit Juice” or “Vegetable Juice Color.”
The draft guidance will be available for public comment for 60 days starting December 14, 2016. The FDA will consider all comments before completing a final version.
To submit comments by mail, send to FDA at: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
All comments must include the agency name and docket number.
Additional Information:
05/11/2017 09:45 PM EDT
Lamb Weston is recalling 14 ounce packages of Red Robin Burgers and Brews Crispy Onion Rings manufactured by Fry Foods and sold in grocery stores, because the product may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
05/11/2017 08:28 PM EDT
Trident Seafoods Corporation is issuing a voluntary recall of select lots of frozen Multi-Grain Alaskan Cod, Net Wt. 12, oz., because they may contain small pieces of plastic. Consumption of these products may pose a choking hazard or other physical injury to the mouth.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin
What's New on the FDA Drugs Site
May 11, 2017
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Trials Snapshots: RYDAPT
- FDA Drug Shortages
- Albuterol Sulfate Inhalation Solution (0.5%) (Updated - Resolved)
- Delavirdine Mesylate (RESCRIPTOR) Tablets (New - Discontinuation)
- Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
- National Drug Code Directory
- Office of Pharmaceutical Quality - Emerging Technology Programpromotes the adoption of innovative approaches to pharmaceutical manufacturing.
- Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)
New and Generic Drug Approvals
May 11, 2017
May 10, 2017
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