As the Obama administration drew to a close, the Food and Drug Administration's Centre for Food Safety and Applied Nutrition (CFSAN) continued to release multiple final or interim final rules and guidance documents pertaining to food safety, nutrition labelling and cosmetic safety. The CFSAN also began posting adverse event reports for foods and cosmetics and extended its comment period for 'healthy' claims in food labelling.
The Food and Drug Administration recently finalised its August 2013 draft guidance entitled "Frequently Asked Questions About Medical Foods; Second Edition". Although the draft guidance was issued nearly three years ago and was the subject of numerous comments from stakeholders, the final guidance reflects few changes and ignores the legal and science-based comments from the industry.
The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the Biologics Price Competition and Innovation Act. The guidance takes the surprising step of limiting innovator exclusivities as part of 'deeming' products to be licensed as biologics under Section 351 of the Public Health Service Act.