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FDA Issues First Draft Guidance Document on Intentional Adulteration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 to Revise Approach to Labeling Some Added Sugars

As previously reported on this blog, FDA published a draft guidance in February 2018 to help industry declare added sugars on the label of pure honey, pure maple syrup, and certain cranberry products. More than 3,000 comments were submitted on the draft guidance by the June 15, 2018 deadline. The comments on the draft guidance can … Continue Reading

California Coffee May No Longer Require Cancer Warnings

On June 15, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed a new regulation clarifying that cancer warnings are not required for coffee under Proposition 65. Proposition 65 is a right-to-know law that requires businesses to provide warnings when they knowingly cause exposures to chemicals that the state has listed as causing cancer … Continue Reading

FDA Announces July 12, 2018 Public Meeting on Foods Produced Using Animal Cell Culture Technology

  Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013.  The technology involves using cell culturing techniques to multiply a small amount of cells taken from an animal to produce foods that resemble traditional meat, poultry, and seafood.  As commercial-scale production of cultured meat … Continue Reading

FDA Releases Guidance on Dietary Fiber

Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels”.  This direct-to-final guidance provides additional clarity on which isolated and synthetic non-digestible carbohydrates (NDCs) will be recognized by … Continue Reading

FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals

FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3:  General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals. Under Section 512(b)(1) of … Continue Reading

Senate Released Bipartisan Draft of Farm Bill

As previously reported on this blog, in March 2018, House Agricultural Committee Chairman Michael Conway delayed the release of the draft law renewing farm and nutrition programs due to opposition to cuts to the Supplemental Nutrition Assistance Program (SNAP). SNAP offers nutrition assistance to more than 47 million eligible, low-income individuals and families, and is … Continue Reading

Bipartisan Bill Would Protect State Marijuana Laws

Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7. The bill would allow states, U.S. territories, and federally recognized tribes to choose how to regulate the use of marijuana within the borders of their state without federal interference. However, the bill would leave certain … Continue Reading

FDA Again Targets Bulk Quantities of Pure or Highly Concentrated Caffeine Sold to Consumers as Dietary Supplements

  As previously reported on this blog, FDA sent Warning Letters to five companies that distributed pure powdered caffeine in 2015 and advised that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”  FDA stated in the letters that it concluded that pure powdered caffeine is adulterated … Continue Reading

FDA and CDC Release Results of 2017 National Youth Tobacco Survey

On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey.  Total number of high- and middle-school tobacco users of any tobacco product continued to fall to unprecedented levels, dropping over 20% between 2011 and 2017, from approximately 4.56 million to 3.62 million youth users.  Comparing tobacco use as a percentage … Continue Reading

FDA and USDA Announce Collaborative Effort to Align Produce Safety Requirements

On June 5, 2018, FDA and USDA announced a new collaborative effort to streamline produce safety requirements for farmers by aligning the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule. This effort follows the signing of a formal agreement in … Continue Reading

WHO Panel Holds Back on Calling for Sugary Drink Tax

An independent panel advising the World Health Organization (WHO) did not recommend taxing sugary drinks in a report, titled, “A Time to Deliver.” While the report, released June 1, 2018, recommends that governments give priority to restricting the marketing of unhealthy products (that contain excessive amounts of sugars, sodium, saturated fats and trans fats) to … Continue Reading

Consumer Groups Urge FDA to Establish Traceability Requirements for High-Risk Foods and Designate Leafy Greens as High-Risk

A May 24 letter from nine consumer and food safety groups urges the U.S. Food and Drug Administration (FDA) “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.”  The six-page letter was signed by the Center for … Continue Reading

USDA Issues Guidelines Regarding Livestock Slaughter and Processing Inspection Exemptions

On May 24, the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) issued a guideline: FSIS Guideline for Determining Whether a Livestock Slaughter or Processing Firm is Exempt from the Inspection Requirements of the Federal Meat Inspection Act.  Absent an exemption, all establishments where cattle, goat, swine, or sheep are slaughtered … Continue Reading

Continuing Fallout from E. Coli Outbreak in Romaine

According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop in retail sales of romaine as compared to the previous year and a 27.6% drop in sales of lettuce overall. Retailers, restaurants, and growers are already facing … Continue Reading

FDA Issues Food Facility Registration Small Entity Compliance Guide

FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Section 415 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to … Continue Reading

FDA Encourages Importer Preparation for Next VQIP Application Cycle

As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program … Continue Reading

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

Aquaculture Company’s Woes in Washington State Continue

The Washington Department of Fish and Wildlife (WDFW) recently rejected Cooke Aquaculture’s request to move 800,000 Atlantic salmon into Puget Sound net pens. WDFW cited two reasons for denying the permit. The Atlantic salmon that would have been transported to the Puget Sound net pens tested positive for a form of the fish virus PRV … Continue Reading

FDA’s ‘Data Dashboard’ Expansion Makes Supply-Chain Verification Searches Easier

  Three FDA Food Safety Modernization Act (FSMA) rules (Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals) require importers and facilities to … Continue Reading

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