Tag Archives: GUIDANCE

FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) … Continue Reading

FDA Commissioner Issues Statement Touting Menu Labeling Rule, Announces Additional Guidance is Forthcoming

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar … Continue Reading

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

USDA-FSIS Issues Updated Guidelines for Premarket Label Approval

The labeling of meat and poultry products primarily falls under the jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). FSIS administers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). Both the FMIA and the PPIA require food manufacturers to obtain prior approval for labels of … 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 Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

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

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

FDA Formally Extends Menu Labeling Compliance Date to 2018

As covered on this blog last week, on April 26, 2017, the FDA submitted an interim final rule (IFR) to the Office of Management and Budget (OMB) seeking an “Extension of Compliance Date” for FDA’s menu labeling requirements. The menu labeling provisions were added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  … Continue Reading

FDA Delays Menu Labeling Rule

As previously covered on this blog, over the past few years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the … Continue Reading

FSIS Issues Updated Guidance Concerning Beef and Veal Slaughter Best Practices

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

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

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

Menu Labeling Update

As previously covered on this blog, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially … Continue Reading

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

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

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

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

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

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

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

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

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”

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

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

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
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