FDA Enforces New Dietary Ingredient Notification Requirement With Import Alerts
This article was originally published in The Pink Sheet Daily
Supplement industry stakeholders say FDA is detaining without inspection imported products previously allowed entry, including synthetic botanicals and ingredients it asserts should be covered in NDI notifications. Firms can reduce their vulnerability by reviewing alerts before contracting with suppliers.
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FDA’s position “is neither scientifically justified, logical nor in the interest of the public health,” CRN argues, asking FDA to reverse its position on synthetic botanicals outside the agency’s revision of the NDI draft guidance.
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.