FSVP means foreign supplier verification program. It is the written program a food importer uses to make sure each foreign supplier is producing food that meets U.S. safety rules. Shehadeh Giannamore, PLLC represents importers and foreign manufacturers when FDA holds …
A PCQI is a preventive controls qualified individual. That is the person who prepares, or oversees preparation of, the written food safety plan at a facility covered by FDA’s preventive controls rule. Shehadeh Giannamore, PLLC works with food companies on …
The FSMA 204 traceability rule requires extra records for certain foods so FDA can trace them faster during an outbreak. It does not apply to every food, and it is not a labeling rule. Shehadeh Giannamore, PLLC advises food companies …
The Delaney Clause tells FDA it cannot approve a food additive, or list a color additive, that has been shown to cause cancer in people or animals. It is a yes-or-no bar. It is not the test FDA uses for …
An FDA warning letter is a written notice from the U.S. Food and Drug Administration that the agency believes your company has committed significant violations of the laws FDA enforces. FDA sends it to give the company a chance to …
An FDA Form 483 is the list of observations an investigator hands you at the end of an inspection. It is not a Warning Letter, and it is not FDA’s final position that you broke the law. It is the …
Red Dye 3 is on the way out of food and ingested drugs in the United States, but it is not already gone from every shelf. FDA has ordered an end to FD&C Red No. 3 in those uses. Food …
GRAS status means qualified experts generally recognize a specific use of a substance in food as safe. It is not a sticker FDA issues, and it is not a property the ingredient carries into every product. Shehadeh Giannamore, PLLC reviews …
Anyone can type a new Shopify product description, but not everyone can tell whether the new version is compliant. The people who can rewrite supplement product descriptions to remove disease claims are the founder, a copywriter, an agency, or a …
No law requires a supplement brand to hire an FDA lawyer before running Meta or Google ads. For many new Shopify supplement brands, though, the first paid campaign is a better moment for a legal review than the store launch …