Label Update Service for all FDA regulated products, including:
▪ dietary supplements
▪ medical devices
Label Update Service for all FDA regulated products, including: ▪ foods ▪ dietary supplements ▪ drugs ▪ medical devices ▪ cosmetics.
Labeling of a food, drug, device, cosmetic, or tobacco product is deemed to be misleading if it fails to reveal material facts.
Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.
If the label does not include the required domestic address or phone number through which the responsible person (manufacturer,
packer, distributor, or retailer identified on the drug label) may receive a report of a serious adverse event associated with the use of the drug product, it is misbranded.
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