OTC Diagnostics Forecast: Growing With Pandemic But High Bar For Approval Could Slow Spread

Sample-collection kit and testing firms acknowledge regulatory approval for OTC sales can be as complicated as the technology behind their products. But consumers have OTC access to numerous at-home collection kits for tests for indications of diseases or medical conditions as well as for genealogy. Kits approved for testing for influenzas or other infections also should become available OTC, say industry stakeholders.

Pixel is the first at-home collection kit for COVID-19 allowed for OTC distribution in the US nearly a year after national health emergency was declared due to the pandemic.

Consumer demand for home-use COVID-19 tests points to a growing market for OTC diagnostic products following the end of the novel coronavirus pandemic, one that medical technology providers are targeting.

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Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
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France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.