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Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health benefits associated with cannabis products. More than 110 speakers, including academic researchers, trade associations and cannabis product manufacturers, presented to the FDA panel during the all-day hearing. Below we outline the notable points from the hearing, including statements by FDA officials and interesting speaker comments. (more…)




FDA to Regulate Brewers and Distillers That Sell Waste Grain for Animal Feed

The U.S. Food and Drug Administration (FDA) will publish its Preventive Control Rule for Feed next Tuesday, October 29, 2013.  The FDA’s Fact Sheet about the proposed rule can be found here.  The comment period is 120 days and comments accordingly should be due on or around February 26, 2014.  More information is available on the following FDA webpage: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm.

Quite notably, the FDA rule proposes to cover breweries and distilleries if they sell spent grain to farmers for use in animal feed.  This aspect of the rule could regulate hundreds of breweries, distilleries and ethanol plants as animal feed producers.  The rule does propose exempting smaller companies, suggesting between $.5 and $2.5 million in feed sales as the appropriate threshold for regulation.

Among other things, application of the proposed rule to a facility would require:

  1. a written food safety plan;
  2. hazard analysis;
  3. preventive controls for hazards that are reasonably likely to occur;
  4. recall plan for animal food with a hazard that is reasonably likely to occur;
  5. monitoring;
  6. corrective actions;
  7. verification; and
  8. associated record keeping.

The proposed rule also would establish specific good manufacturing practices (GMP) for animal feed.

Any brewer or distiller currently supplying spent grain for feed should pay attention to these proposed rules.  Participation in the comment period may reduce the impact of these regulations or obtain some exemption for the industry.  If those efforts fail, companies above the regulation’s size threshold (whatever that turns out to be) must either gear up to comply with these rules or consider new ways to dispose of their spent grains.




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