Tag Archives: RULEMAKING

“Healthy” Update: Industry, Others Weigh In on ‘Healthy’ Claims

As previously reported on this blog, FDA received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods, and in September 2016, FDA issued a request … 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

FDA Issues Interim Final Rule Amending Health Claim Requirements

FDA has issued an interim final rule to allow more raw fruits and vegetables to bear health claims concerning the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease. To make a claim regarding the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease (CHD) … 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

Import(er) Alert: E-Filing Proposed Rule

FDA proposes e-filing requirements to facilitate product imports. FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports. Earlier … 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

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

Honing in on “Healthy”

FDA to revisit definition of “healthy” on food labels. FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per … 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

Pork Parasite Proposal

FSIS proposes to eliminate trichinae control requirements it deems unnecessary. Trichinella is a parasitic worm that can infect humans and other animals.  Although relatively few cases of human infection are reported each year, swine are known to be the primary source of such infections.  In 2001, the U.S. Department of Agriculture’s (USDA) Food Safety and … 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

Gluten-Free Go-Round

FDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods. As previously covered on this blog, FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting … Continue Reading

Sounds Fishy: New Seafood Traceability Program

NOAA proposes new traceability program for certain types of seafood. For years, the seafood industry has grappled with the issue of “seafood fraud,” which includes the substitution of cheaper species for more expensive ones.  Data from one of the largest seafood fraud investigations in the world indicate that snapper and tuna were mislabeled most frequently, … 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
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