FDA updates reporting requirements for product adverse effects

The U.S. Food and Drug Administration has updated its guidance for reporting adverse effects of various products, including dietary supplements, during the coronavirus pandemic.

The FDA does not consider CBD a dietary supplement. But many CBD manufacturers do and follow FDA guidance on making and selling dietary supplements.

The agency made the announcement this month, saying companies should “focus their limited resources” on certain reporting adverse effects for:

  • reports related to medical products indicated for the treatment or prevention of the virus causing the pandemic;
  • product-related safety issues and other things under the agency’s “special conerns” list.

The FDA said in a statement that during a pandemic, “industry and FDA workforces may be reduced because of high employee absenteeism.”

The FDA says that firms should stotre lower-priority adverse effects for reporting at the end of the pandemic.

The FDA also said that the “guidance is not intended to discourage adverse event reporting during a pandemic by firms that are able to continue reporting operations.”

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