Tag Archives: GUIDANCE

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

Posted on August 16, 2017

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 Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

Posted on August 11, 2017

Mechanical filtration technologies available for milk processing include ultrafiltration. Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product. FDA’s regulations specify the standards of identity … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

Posted on August 8, 2017

As previously reported on this blog, the U.S. Food and Drug Administration 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 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

FSIS Issues Updated Guidance Concerning Beef and Veal Slaughter Best Practices

Posted on March 17, 2017

As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products. To help achieve its enumerated food safety goals, FSIS works with industry to develop and promote best practices at slaughter that may be used to prevent, eliminate, or reduce levels of potential microbiological … Continue Reading

FDA announces public meeting to obtain input on the use of the term “healthy” in the labeling of human food

Posted on February 16, 2017

Today, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. As previously covered on this blog, on September 28, 2016, FDA published a request for comment in the Federal Register. The comment period, which was originally scheduled to end … Continue Reading

Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns

Posted on January 17, 2017

As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received more than 7,000 comments on the draft guidance by the Dec. 12, 2016, due date. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer … Continue Reading

FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

Posted on December 8, 2016

As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food … Continue Reading

Scaling Back Sodium: GMA Comments on Short-term Sodium Reduction Guidelines

Posted on October 27, 2016

The Grocery Manufacturers of America (GMA) has requested that the short-term sodium reduction goals be extended to at least four years, and that FDA account for differing functional roles of sodium in its proposed sodium targets for certain food categories. As previously covered on this blog, on June 1, 2016, FDA issued a draft guidance document that provides … Continue Reading

FDA Updates Food Facility Registration Product Categories

Posted on September 28, 2016

FDA has issued guidance updating the food product categories that companies can select when registering as a food facility with the agency. 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. … Continue Reading

FDA Issues Guidance for the Labeling of Infant Formula

Posted on September 19, 2016

On the heels of recently released draft guidance concerning substantiation for infant formula structure/function claims, FDA has issued guidance regarding the labeling of infant formula. Infant formula is clearly receiving attention at FDA in 2016. Just earlier this month, as covered on this blog, FDA released draft guidance concerning appropriate substantiation for structure/function claims made … Continue Reading

Scaling Back Sodium – FDA Extends Comments Period for Draft Guidance

Posted on August 22, 2016

FDA has extended the comments period for its draft guidance regarding sodium reduction in food. As previously covered on this blog, on June 1, 2016, FDA issued a draft guidance document that provides voluntary sodium reduction targets for the food industry, specifically aimed at food manufacturers, restaurants, and food service operators. The draft guidance sets forth … Continue Reading

Supplement Spotlight: FDA Revises NDI Draft Guidance

Posted on August 11, 2016

FDA issues long-awaited revised Draft Guidance on new dietary ingredient notifications (NDINs) for dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a new dietary ingredient (NDI) to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary … Continue Reading

FDA Guidance: Nutrients in Small Amounts

Posted on July 8, 2016

FDA finalizes guidance on declaration of small amounts of nutrients and dietary ingredients on nutrition labels. In August 2015, FDA issued a draft guidance document stating the Agency’s policy on the declaration of small amounts of nutrients and dietary ingredients on nutrition labels. The draft guidance provided FDA’s recommendations on how to comply with nutrition … Continue Reading

FDA Guidance: Prior Notice

Posted on June 16, 2016

FDA issues third edition of guidance regarding prior notice for imported food. Under Section 801(m) of the Federal Food, Drug, and Cosmetic Act, FDA requires the submission of “prior notice” in advance of an article of food arriving at the U.S. border. “Food” is defined broadly to include finished foods, ingredients, and raw materials. The … Continue Reading

FDA Draft Guidance: Scaling Back Sodium

Posted on June 2, 2016

FDA issues draft guidance to encourage food industry to reduce sodium added to food. According to FDA, average sodium intake in the U.S. is too high at approximately 3,400 mg/day. Approximately 75% of total sodium intake comes from processed and commercially prepared foods. For years, the Agency and the food industry have considered various approaches … Continue Reading

FDA Final Guidance on “Evaporated Cane Juice”

Posted on May 25, 2016

FDA releases final guidance regarding use of the term “evaporated cane juice” on food labeling. As previously covered on this blog, food companies have been grappling for years with the use of the term “evaporated cane juice” on product labels. Various lawsuits have alleged that the term violates federal and state laws, citing as support a … Continue Reading

FSMA Guidance: Qualified Facility Q&A

Posted on May 16, 2016

FDA issues draft guidance regarding “qualified facilities” under FSMA HARPC framework. In September 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). Under both the human food rule and the animal food rule, “qualified facilities” are subject to modified requirements. … Continue Reading

Medical Food FAQs

Posted on May 12, 2016

FDA issues final guidance related to medical foods. Medical foods are a special sub-category of foods that are “formulated to be consumed or administered enterally under the supervision of a physician.” Further, medical foods are “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, … Continue Reading

Pets and Vets: Therapeutic Vet Diet CPG Finalized

Posted on May 3, 2016

FDA finalizes enforcement policy with respect to therapeutic veterinary diets. As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or feed, including pet food. However, in reality, therapeutic pet food products have been marketed for years without official drug approvals in accordance with FDA’s longstanding enforcement discretion … Continue Reading

Infant Formula Guidance Issued

Posted on April 18, 2016

FDA issues guidance on production of exempt infant formula. In 2014 — 17 years after the initial proposed rule was issued — FDA finalized its rulemaking related to the manufacture of infant formula. However, the rule does not apply to facilities that manufacture “exempt infant formula,” defined by law as an infant formula which is … Continue Reading

We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.

I Agree