Regulatory Hot Topics – April 2019

What’s going on in the ever-changing world of regulatory? Our resident regulatory guru, Ashley Brooks, is here to help! Here are some of the most pressing hot topics in regulatory that food companies should be paying attention to.

Poppy Seed Legislation Introduced in Senate

Senator Tom Cotton (R-Arkansas) introduced legislation on Wednesday, April 3rd intended to eliminate the sale of poppy seeds containing unsafe levels of morphine and other opium alkaloids. This legislation is in response to poisonings from products marketed as “unwashed” poppy seeds for tea that contained extremely high levels of opioids compared to typical levels in the food trade. If approved by Congress and signed into law by the president, unwashed poppy seeds will be considered an adulterant, and it would be illegal to sell them or any foods or beverages that contain them.

Poppy seeds manufactured by Fuchs North America are food grade and are cleaned to remove debris and majority of opioid residues. Due to the seed’s irregular and oily surface trace alkaloids remain after the cleaning process. Fuchs only contracts with farmers that certify analysis of safe alkaloid content. Heat treatment (such as baking) of finished products further degrades the levels of opioid residues.

Sesame Seeds Likely to Become a Major Allergen

FDA Commissioner Scott Gottlieb recently stated that he is “confident” that FDA will move forward with stricter sesame labeling. Last fall, FDA issued a request for information on allergen labeling and cross-contact issues for sesame. Currently, sesame is not required to be disclosed as an allergen, and in some cases, sesame may be exempt from being listed by name in the ingredient statement on food packages. The move would put sesame alongside the “Big 8” allergens (peanuts, tree nuts, milk, eggs, soybean, wheat, fish, and shellfish) named by the Food Allergen Labeling and Consumer Protection Act of 2004.

FDA Schedules First CBD Public Hearing

The first public hearing on cannabidiol (CBD) has been scheduled for May 31, 8 a.m.-6 p.m May 31 at FDA’s White Oak Campus,10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, Md.

The FDA continues to emphasize that CBD is not allowed in food or beverage products at this time. They have issued warning letters to companies marketing CBD products “with egregious and unfounded claims that are aimed at vulnerable populations.”

Additionally, the FDA is forming an internal “working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.” The working group plans to share information and findings with the public as early as summer 2019.

 

Need help navigating regulatory requirements? Reach out to Ashley at [email protected].

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