Hello Forums Team,
I need urgent help to understand how a specific policy is being applied, and I’m struggling to get answers that make any sense.
My topical oils were wrongly flagged as unapproved drugs requiring National Drug Code numbers, presumably because of the presence of progesterone. The problem is the FDA doesn’t give NDC numbers to non-drugs.
My products are cosmetics, not medications, and there are no medical claims asserted in the listings or on the products.
Per the FDA National Drug Code Directory,<fda website> /drugs/drug-approvals-and-databases/national-drug-code-directory, under the Important considerations about the NDC Directory section, the fourth paragraph states very clearly:
“Assignment of NDC number to non-drug products is prohibited.”
Topical cosmetic products aren't classified as drugs unless there are medical claims being asserted. Why are my non-medical skin oils being held to the standard of prescription drugs?
FDA regulations on progesterone apply only to oral and injected forms, not to topicals that are not making prohibited health claims.
Affected ASINs: B008SFUOP0, B00D2G28LS, B0BS1T4R2B.
I’ve submitted my product label pictures, product pictures, Certificates of Analysis, and FDA references in case ID 17925154361. I was told I would receive an update on a resolution in the same case, but all responses are just the same copy-paste reply with no guidance on how to proceed.
Can you help me understand this? Can you please escalate this to someone who understands my issue and can connect the dots?
