What Is FSVP, and What Must Importers Verify About Foreign Suppliers?
FSVP means foreign supplier verification program. It is the written program a food importer uses to make sure each foreign…
What Is a PCQI, and Does Your Food Facility Need One?
A PCQI is a preventive controls qualified individual. That is the person who prepares, or oversees preparation of, the written…
What Is the FSMA 204 Traceability Rule, and Who Must Comply?
The FSMA 204 traceability rule requires extra records for certain foods so FDA can trace them faster during an outbreak.…
What Is the Delaney Clause, and How Does It Affect Your Food Additive?
The Delaney Clause tells FDA it cannot approve a food additive, or list a color additive, that has been shown…
What Is an FDA Warning Letter, and Why Did Your Company Get One?
An FDA warning letter is a written notice from the U.S. Food and Drug Administration that the agency believes your…
What Is an FDA Form 483, and How Should You Respond Before It Becomes a Warning Letter?
An FDA Form 483 is the list of observations an investigator hands you at the end of an inspection. It…
Is Red Dye 3 Banned, and What Do FDA Color Additive Rules Require?
Red Dye 3 is on the way out of food and ingested drugs in the United States, but it is…
What Is GRAS Status, and When Does Your Ingredient Need FDA Notification?
GRAS status means qualified experts generally recognize a specific use of a substance in food as safe. It is not…
How Do You Get Your Shopify Supplement Store Reviewed by an FDA Lawyer Before Launch?
To get a Shopify supplement store reviewed by an FDA lawyer before launch, gather the formula, label proofs, store preview,…
Who Can Rewrite Shopify Supplement Product Descriptions to Remove Disease Claims?
Anyone can type a new Shopify product description, but not everyone can tell whether the new version is compliant. The…