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FDA Proposes New Graphic Warnings for Cigarettes

By Benjamin Wolf on August 16, 2019

The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of enactment of the TCA. Accordingly, FDA issued a final rule requiring graphic warnings on June 22, 2011. However,…

The Daily Intake

EPA Refuses to Approve Glyphosate Labels with Proposition 65 Cancer Warning

By Jill Mahoney on August 15, 2019

In a direct rebuke of Proposition 65’s listing of glyphosate as a carcinogen, the US Environmental Protection Agency (EPA) issued a press release on August 8, 2019 announcing that it would no longer approve glyphosate labels with the Proposition 65 warning for cancer. EPA Administrator Andrew Wheeler is quoted in the press release as stating, “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a…

The Daily Intake

FDA Issues First Warning Letter to Food Importer Under FSVP

By Jill Mahoney on August 14, 2019

On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP). As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP…

The Daily Intake

Hazelnut Crème Coffee False Advertising Lawsuit Revived

By Erin on August 13, 2019

1st Circuit Gives Coffee Buyers 2nd Shot at False Ad Suit (subscription to Law360 required) On August 8, 2019, the U.S. Court of Appeals for the First Circuit reversed a district court’s dismissal of a lawsuit charging that the label on New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product does not contain hazelnuts. Kathy Dumont originally brought a putative class action against New England Coffee Company and Reily Foods…

The Daily Intake

FDA is Asked to Approve Vitamin D3 For Use as a Nutrient Supplement in Grain-Based Nutrition Bars and at Higher Levels Than Currently Affirmed as GRAS in Breakfast Cereals

By Lisa Alsobrook on August 12, 2019

As a vitamin that is assigned a Reference Daily Intake (RDI) in 21 C.F.R. § 101.9(c)(8)(iv), vitamin D is an “essential nutrient.” Vitamin D without a subscript represents either vitamin D2 or vitamin D3, which are the two major physiologically relevant forms of vitamin D. Vitamin D is affirmed as generally recognized as safe (GRAS) for use as a nutrient supplement in certain foods at the specified maximum levels in 21 C.F.R. § 184.90. The Food and Drug…

The Daily Intake

FSVP Follow-up

By Benjamin Wolf on August 9, 2019

With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation. The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported. Each food item being imported must have its own FSVP review. An Import Alert is guidance within the Food…

The Daily Intake

Inspections Begin Under FDA’s Produce Safety Rule

By Samuel Jockel on August 8, 2019

As our readers may know, the FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. The compliance dates for the Produce Safety Rule depend on the size of the farm and can be found here. While compliance was set to begin on January…

Tomorrow's Food and Feed

Fatty Acids Recommendations Remain Subject to Discussions

By Katia Merten-Lentz & Thaïs Payan on August 7, 2019

On 15 May 2018, the World Health Organization (WHO) called for the elimination of industrially-produced trans-fatty acids from the global food supply and released draft guidelines on saturated fatty acid and trans-fatty acid intake for adults and children. The draft guidelines suggest that adults and children reduce their intake of saturated fatty acids to less than 10% of total energy intake and their intake of trans-fatty acids to less than 1% of total energy intake.…

The Continuum of Risk

China Is Drafting First E-Cigarette Standard

By Azim Chowdhury, David Ettinger, Eric Gu & Mary Liu on August 7, 2019

Electronic cigarettes may soon become much more widely available in the world’s largest tobacco market: The People’s Republic of China. With over 300 million smokers, China has the world’s largest smoking population – which directly results in approximately 1 million deaths annually. [1] While the global e-cigarette market has experienced rapid growth over the last decade, reduced-harm products have only recently started becoming popular domestically, despite the fact that the modern e-cigarette was invented in…

The Continuum of Risk

China Is Drafting First E-Cigarette Standard

By Azim Chowdhury, David Ettinger, Eric Gu & Mary Liu on August 7, 2019

Electronic cigarettes may soon become much more widely available in the world’s largest tobacco market: The People’s Republic of China. With over 300 million smokers, China has the world’s largest smoking population – which directly results in approximately 1 million deaths annually. [1] While global e-cigarette market has experienced rapid growth over the last decade, reduced-harm products have only recently started becoming popular domestically, despite the fact that the modern e-cigarette was invented in China,…

Keller Heckman

Keller Heckman Blogs

Blog Authors

FDA Proposes New Graphic Warnings for Cigarettes

EPA Refuses to Approve Glyphosate Labels with Proposition 65 Cancer Warning

FDA Issues First Warning Letter to Food Importer Under FSVP

Hazelnut Crème Coffee False Advertising Lawsuit Revived

FDA is Asked to Approve Vitamin D3 For Use as a Nutrient Supplement in Grain-Based Nutrition Bars and at Higher Levels Than Currently Affirmed as GRAS in Breakfast Cereals

FSVP Follow-up

Inspections Begin Under FDA’s Produce Safety Rule

Fatty Acids Recommendations Remain Subject to Discussions

China Is Drafting First E-Cigarette Standard

China Is Drafting First E-Cigarette Standard

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