Tag Archives: FINAL RULE

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

FSMA Final Rule Watch: Sanitary Transportation

FDA releases final rule to implement sanitary food transportation requirements under FSMA. On April 5, FDA announced the issuance of a final rule to implement sanitary food transportation requirements under 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 summarizing … Continue Reading

Cattle Call: FDA Finalizes BSE Rule

FDA issues final rule related to BSE risk reduction. Bovine spongiform encephalopathy (BSE) — also called “mad cow disease” — is a fatal and progressive neurologic disease that affects cattle.  BSE poses a risk to humans because people can get a version of the disease called variant Creutzfeldt-Jakob disease (vCJD).  There is no known treatment … Continue Reading

Fatty Acid Follow-Up

FDA issues guidance to help food companies comply with final rule for omega-3 fatty acid claims. In April 2014, FDA published a final rule prohibiting certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids:  docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); and alpha-linolenic acid (ALA).  In short, the rule eliminated a … Continue Reading

Looser Livestock Export Rules

USDA loosens livestock export rules. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has regulatory authority over both the import and export of livestock products.  In the import context, APHIS works to ensure that products entering the U.S. meet the Agency’s entry requirements to exclude pests and diseases.  … Continue Reading

PFC Packaging Proscription

FDA bans three chemicals used in the production of paper and paperboard. FDA regulates the use of so-called “indirect” food additives.  In general, these are substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food.  Many indirect additives are the subject of … Continue Reading

USDA Beefs Up Product Tracing

USDA issues final rule imposing new recordkeeping requirements on beef producers to improve traceability. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the safety of meat products in the United States.  In recent years, FSIS has struggled with limits on its ability to trace the source of foodborne illness outbreaks involving … Continue Reading

Postscripts

Parties settle “Made in USA” lawsuit in California. (subscription to Law360 required) As previously covered on this blog, a product may bear a “Made in USA”-type (MIU) claim in accordance with federal guidelines where “all or virtually all” of the product is made in the U.S.  Until a recent statutory change, California’s MIU claim standard had been … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summaries of FSMA final rules related to produce safety standards, foreign supplier verification program, and third-party certification program. As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the produce safety standards, the foreign supplier verification program (FSVP), and the third-party certification program under the FDA Food Safety Modernization … Continue Reading

Gone Fishing

Mandatory USDA catfish inspections to start March 2016. FDA regulates the majority of the U.S. food supply, while the U.S. Department of Agriculture (USDA) exercises jurisdiction over meat, poultry, and egg products.  Although FDA historically has regulated fish and fishery products, the 2008 Farm Bill required FDA to divest its authority over the inspection of … Continue Reading

FSMA Friday

FDA issues three long-awaited final rules to implement FSMA provisions. FDA has issued final rules to implement three major provisions of the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on November 27, 2015. Click here for FDA’s overview of the final rule to implement the produce safety … Continue Reading

FSMA Final Rule Watch

FDA finalizes three additional FSMA rules; publication imminent. Although FDA’s implementation of the FDA Food Safety Modernization Act (FSMA) is well underway, the Agency has yet to issue several final rules to implement major provisions of the law.  In 2012, two advocacy groups — the Center for Food Safety and the Center for Environmental Health … Continue Reading

FSMA Final Rule Follow-Up

K&H publishes summaries of FSMA final HARPC rules for human food and animal food. As promised, Keller and Heckman LLP has prepared summaries of FDA’s final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA). Click here for our summary of … Continue Reading

FSMA: Final HARPC Rules Published

Federal Register publications available for final rules to implement FSMA HARPC provisions for human and animal food. On September 10, 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA). On September 17, 2015, the final rules were published in the Federal Register. … Continue Reading

Finally, FSMA

FDA issues long-awaited final rules to implement FSMA HARPC provisions for human and animal food. FDA has issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on September 17, 2015, and the … Continue Reading

Where’s the Beef?

USDA to permit beef imports from Argentina and Brazil. The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is tasked with protecting the United States from animal and plant pests that could threaten the domestic agricultural market and the food supply.  Regulations in 9 CFR Part 94 prohibit or restrict the … Continue Reading

Vetting Antibiotic Use

FDA finalizes rule to require veterinary supervision of antimicrobial use in food-producing animals. FDA and the animal feed industry have been working for years to address concerns about the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  As previously covered on this blog, FDA has requested voluntary industry efforts to reduce the … Continue Reading

Tender is the Meat

USDA issues final rule implementing new labeling requirements for mechanically tenderized beef. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) regulates the quality, safety, and labeling of meat and poultry products marketed in the United States. On May 13, 2015, FSIS announced new labeling requirements for raw or partially cooked beef … Continue Reading
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