Consequences of Non-Compliance
Failing to comply with the US FDA’s regulations can lead to serious repercussions for manufacturers, such as:
- Warning Letters: Manufacturers may receive warnings for unsubstantiated claims or labeling violations.
- Product Recalls: The US FDA can mandate product recalls if the product is found to be unsafe or mislabeled.
- Legal and Financial Liabilities: Manufacturers risk facing lawsuits from consumers or regulatory authorities for non-compliance, which can tarnish brand reputation and incur significant legal costs.