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Expanding US FDA Mandatory Recall Authority To All Drugs Gets House Appropriators’ Approval

Executive Summary

Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.

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Support To Grant US FDA Authority To Order Recalls Of All Drugs Grows With Bill Introduced In Senate

Sen. Gary Peters says FDA should have the authority because relying on drug marketers to voluntarily recall products the agency has deemed unsafe isn’t sufficient to protect public health. He notes that manufacturers of OTC hand sanitizers imported from Mexico and found to contain methanol haven’t cooperated with the FDA on recalling the products.

More Stains Surface On US Hand Sanitizer Market With Production Standards Loosened

In addition to a large and growing number of products made in Mexico and found to contain methanol on recall, sanitizers made by a Washington state dental whitening product firm contain ethanol at below labeled levels and the presence of undeclared isopropyl alcohol. Recent recalls also include injectable CBD formulations a Seattle firm marketed OTC and a New Jersey’s firm dandruff shampoo produced with water that failed US Pharmacopeia specifications 

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“Food Allergy Safety, Treatment, Education, and Research Act of 2019” would amend FDA regulations to include sesame as major allergen and allow agency to add other ingredients as major allergens based on prevalence and severity of allergic reactions. Separately, FDA FY2021 budget part of minibus set for House vote week of 20 July.

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