In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.
You may also be interested in...
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.
FTDA and FTC warn Patriot Supreme about noncompliant claims on its website and social media pages promoting CBD to prevent or treat infections from the coronavirus. However, a release Patriot Supreme distributed in July promoting CBD as a COVID-19 remedy remains in online circulation.
“To the extent these claims pertain to the ingestion of peanuts, they are not consistent with the claim in the  Letter of Enforcement Discretion FDA issued in response to a petition for a qualified health claim for ground peanuts and reduced risk of developing peanut allergy,” state CFSAN officials.