Tag Archives: Draft Guidance

FDA Announces New Policies on e-Cigarettes and Cigars to Stem Surge in Youth Smoking

On March 13, 2019, FDA proposed to end the Agency’s current compliance policy on flavored e-cigarettes (other than tobacco-, mint-, and menthol-flavored products), as well as its policy on flavored cigars, in an effort to curb youth smoking rates.  The compliance policy permits “deemed” tobacco products on the market when FDA’s Deeming Rule went into effect on August 8, 2016 to remain … Continue Reading

FDA Releases Second Installment of Intentional Adulteration Draft Guidance

FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first installment was published in June 2018, and a third installment is to follow. The second installment outlines two flexible methods for how facilities can conduct vulnerability assessments … Continue Reading

FDA Issues Policy and Related Draft Guidance on Publicizing List of Retailers in Certain Food Recall Situations

FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released … Continue Reading

FDA Issues First Draft Guidance Document on Intentional Adulteration

As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food Safety Modernization Act (FSMA).  These rules are intended to guard against the deliberate adulteration of food by employees. The 94-page guidance provides an overview of … Continue Reading

FDA Issues Draft Guidance on HARPC for Animal Food

As previously reported on this blog, FDA published 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) on September 17, 2015. The Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170) can be found … Continue Reading

Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and … Continue Reading

FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to refuse imported food from being admitted into the United States if the Agency is not permitted to inspect the foreign establishment that produced the food. … Continue Reading

Menu Labeling Update: FDA Releases Supplemental Draft Guidance

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 Sixth Chapter of Draft Guidance for the Human HARPC Rule

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. To facilitate compliance … Continue Reading

FDA Withdraws Draft Guidance on the Use of Certain Fruit Juice and Vegetable Juice as Color Additives

As previously covered on this blog, in December 2016, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260.  The … Continue Reading

FDA Reopens Comment Period for Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food”

As previously covered on this blog, on December 14, 2016, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant material meets the specifications for fruit juice under § 73.250 or vegetable juice … Continue Reading

FDA Issues Revised Draft Guidance for Control of Listeria monocytogenes in Ready-To-Eat Foods

As our readership is well aware, Listeria monocytogenesis is a pathogen that causes the infection listeriosis and is the source of numerous food recalls.  See examples of recent recalls caused by Listeria monocytogenes contamination here and here.  Listeria monocytogenes can grow in various settings, including cold, refrigerated environments, and is particularly harmful to the elderly, pregnant … Continue Reading

FDA Issues Two Guidance Documents on the Nutrition Facts Label and the Serving Size Final Rules

As our readers are well aware, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.  Detailed summaries of both rules may be found here.  On August 3, 2016, FDA published a Nutrition Facts label “Industry Resources” web page (available here), which includes some questions … Continue Reading

FDA Issues Additional FSMA Draft Guidance Documents for Animal Foods and the Classification of Activities for Farms and Facilities

FDA has issued two draft guidance documents to assist industry with the implementation of Preventive Controls and Current Good Manufacturing Practices under the Animal Food Rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition. The two Draft Guidance documents relating to the Animal Food … 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

Counting Calories – FDA Issues Draft Guidance for Labeling Vending Machine Foods

FDA Issues Draft Guidance and Small Entity Compliance Guide Regarding Calorie Labeling For Vending Machine Foods On December 1, 2014, FDA issued a final rule (79 FR 71259) entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”.  The rule implements the vending machine labeling provisions of the Affordable Care Act that require … Continue Reading

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