FDA and FTC jointly warn five marketers of supplements with claims to treat fertility and other reproductive disorders. The unapproved and misbranded drugs could harm consumers and deter them from seeking effective treatments.
One day US regulators are noting an unapproved OTC contraceptive, the next they’re warning companies making unsubstantiated fertility claims for their products.
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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.
FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”
Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.
European Food Safety Authority finds no cause and effect relationship between Givaudan's Pacran supplement and defense against urinary tract infections.
Manufacturers, marketers and other businesses in the industry may be thinking, “Well, this is different” because the president ordered tariffs on a list of countries rather than on his sole first-term target of China.
