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This month, FDA finalized two rules on current Good
Manufacturing Practices ("cGMP") and preventive control
requirements, see here and here, under the Food and Safety Modernization Act
("FSMA"). These rules cover human and animal food
facilities and aim to ensure the U.S. food supply is safe by
shifting the focus from responding to contamination to preventing
it. Requirements for both rules are quite similar, requiring
owners, operators, or agents of food facilities to implement
written preventive control plans that identify and evaluate known
or reasonably foreseeable hazards in the food, including
biological, chemical, physical, and radiological hazards. The rules
require that such food safety plans must include a hazard analysis,
preventive controls, monitoring, corrective action and verification
procedures, and recordkeeping. The FDA has stated it has evaluated the comments received
from the public, allowing for more flexibility in some of the
rules' requirements. For example, the "farms"
definition has been extended to narrow the kinds of facilities
covered by the rules, and the responsibilities under the
supply-chain program have been reduced by, among other things, not
requiring facilities where hazards are identified and controlled by
a subsequent entity in the distribution chain to implement
preventive controls. Additionally, FDA provides industry with
staggered implementation based on business size, cGMP requirements,
and preventive control requirements. Implementation will occur over
a number of years, beginning on September 17, 2016.
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In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc et al), the Court affirmed a decision from the U.S. District Court of New Jersey.
The bulk of the award, more than $7 million in punitive damages, went to a female anesthesiologist who was allegedly choked and pushed up against the wall in a locker room by a surgeon.
The U.S. Securities and Exchange Commission has issued an alert to retail investors in the cannabis industry following a number of recent enforcement actions.
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