Federal Food Drug and Cosmetic Act

A Hawaiian fruit leather manufacturer is on notice from the FDA after inspectors determined the claims on the company’s product labels, product brochures and website established that its products are drugs.

The Food and Drug Administration reported the drug designation is accurate for the products “because they are intended for use in the cure, mitigation,…

Federal and state inspectors observed numerous problems with manufacturing processes during a 2016 visit to the Tukwila, WA, manufacturing facility of Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products.

The regulators’ ability to take action was limited because the company was not yet required to comply with current Good Manufacturing Practices (CGMP) under…

A South Carolina ice pop manufacturer and an Oregon low-acid canned food producer are both on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent the warning letters to the companies in August and posted them for public view in recent days. Companies are allowed 15 working…