Tag Archives: FINAL RULE

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Approves New Source of Omega-6 Fatty Acids for Dog Food

The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced the approval of a variety of bioengineered safflower as a source of omega-6 fatty acids in dry adult dog food. The final rule amends Title 21 Code of Federal Regulations (C.F.R.) Part 573 (“Food Additives Permitted in Food and Drinking Water of Animals”) … Continue Reading

New Final Rule Strengthens USDA Enforcement of COOL Requirements

Country of Origin Labeling (COOL) requirements at 7 CFR Part 60 and 7 CFR Part 65 require retailers to notify their customers of the country of origin of covered commodities, which include muscle cut and ground lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and … Continue Reading

FDA: No Plans to Reopen Nutrition Facts Label Rule

In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As covered on this blog last … Continue Reading

CFS and Others Sue FDA Over GRAS Rule

FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in … Continue Reading

FDA Considering Requests to Maintain or Extend Scheduled Implementation of Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading

Potential New Head of FDA Open to Delaying Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading

FDA Announces Three Waivers to Sanitary Transportation Rule

By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for … Continue Reading

Dairy Industry Seeks to Delay Implementation of FDA’s Nutrition Facts Rule

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for … Continue Reading

FDA Targets Tobacco Products Claims

Pursuant to Section 201(rr) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, a “tobacco product” is any product made or derived from tobacco intended for human consumption, but excludes drugs, devices, and combination (drug-device) products. A product is a drug, device, or combination product if it is intended to … Continue Reading

Fishy Business: NOAA Finalizes Seafood Traceability Rule

For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  As previously covered on this blog, on February 5, 2016, the Commerce Department’s National Oceanic and Atmospheric Administration (NOAA) issued a proposed rule to establish a new traceability program for certain seafood … Continue Reading

FDA Delays Certain FSMA Compliance Dates and Issues Draft Guidance on Preventive Controls for Human Food

FDA issues HARPC Draft Guidance and delays compliance dates for several key FSMA provisions. FDA issued a final rule today that extends and clarifies the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  These changes are intended to address concerns about the practicality of compliance with certain … Continue Reading

GRAS AT LAST

FDA Issues Final Rule on Food Ingredients that May Be “Generally Recognized as Safe” (GRAS) Although FDA has premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without the Agency’s premarket review or approval if the substance is generally recognized, among qualified experts, to … Continue Reading

Vitamin D-Listed

FDA approves increase in vitamin D added to milk and approves addition to milk alternatives. Many substances added directly to food in the U.S. are marketed on the basis of FDA food additive regulations, which are located in 21 CFR Part 172.  By law, FDA may approve the use of a food additive only after conducting … Continue Reading

FSMA Final Rule: Food Facility Registration

FDA amends food facility registration requirements. Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  The registration requirement has been in effect since 2003.  However, the FDA Food Safety Modernization Act … Continue Reading

Vend Delay

FDA to extend compliance date for vending machine labeling requirements. In December 2014, FDA published a final rule to require calorie declarations for foods sold in vending machines.  Under the rule, calorie declarations must be clear, conspicuous, and prominently placed so that a prospective purchaser may easily read such information prior to making a purchase.  … Continue Reading

Changes to Nutrition Facts & RACCs (+ Complimentary Webinar)

K&H publishes summaries of final rules to revise nutrition and supplement facts labeling requirements and serving sizes. As promised, Keller and Heckman LLP has prepared summaries of FDA’s recently-issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. The final rule revising the Nutrition and Supplement Facts Labels:  (1) … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summary of FSMA final rule to implement intentional adulteration requirements for human food. As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement the intentional adulteration provisions of the FDA Food Safety Modernization Act (FSMA). Click here for our summary of the rule and its implications for the … Continue Reading

FSMA Final Rule Watch: Intentional Adulteration

FDA releases final rule to implement FSMA intentional adulteration provisions for human food. On May 26, 2016, FDA released its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a pre-publication copy of the final rule.  Click here for an FDA fact sheet … Continue Reading

FDA Final Rule Alert: Revised Nutrition Facts and RACCs

FDA releases final rules to revise nutrition labeling requirements. In 2014, FDA issued proposed rules that would revise the Nutrition Facts label requirements.  The proposals included amendments to the Nutrition and Supplement Facts labels and to longstanding reference amounts customarily consumed (RACCs), which are used to determine serving sizes.  In 2015, FDA issued a supplemental … Continue Reading

Tobacco Turmoil

FDA’s regulatory authority extended to all tobacco products. As covered previously on this blog, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any … Continue Reading

FSMA Final Rule Watch: Whistleblower Protection

OSHA issues final rule implementing FSMA whistleblower provisions. The FDA Food Safety Modernization Act (FSMA) added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide added protection for employees who “blow the whistle” and come forward with information about potential food safety problems within their companies or facilities.  Although Section 1012 … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summary of FSMA final rule to implement sanitary transportation requirements for human and animal food. As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA). Click here for our summary of the rule and its implications … Continue Reading
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