Fd&c Violet No. 1--delisted

FD&C Violet No. 1 (also known as Violet No. 1 or CI 42640) is a synthetic organic colorant that was previously approved by the FDA as a food additive. The chemical compound, with CAS number 1694-09-3, belongs to the class of triphenylmethane dyes. It was developed for use as a food colorant to impart violet or purple hues to various food products.

Historically, FD&C Violet No. 1 was used in a limited range of food applications where violet or purple coloring was desired. Its specific food uses were restricted compared to more widely adopted colorants, and it was not extensively utilized across the food industry. The exact products that contained this colorant were limited, and its use was generally confined to specialty items.

FD&C Violet No. 1 was delisted from the FDA's approved color additives list, meaning it is no longer permitted for use in food products in the United States. The delisting decision reflected regulatory determinations regarding the additive's safety profile and suitability for continued approval. According to FDA records, there were zero reported adverse events associated with this colorant and zero recalls linked to its use, suggesting no acute public health incidents occurred from its historical use.

The absence of adverse event reports does not necessarily indicate comprehensive safety data, but rather reflects the limited scale of exposure and use before delisting. Like many color additives evaluated under historical FDA standards, FD&C Violet No. 1 underwent assessment based on the toxicological data and regulatory frameworks available at the time of its approval.

FD&C Violet No. 1 is no longer approved for use in food in the United States. The delisting means manufacturers cannot legally add this colorant to food products sold domestically. This regulatory status distinguishes it from approved colorants like FD&C Red No. 40 or FD&C Yellow No. 5, which maintain current FDA approval and are subject to ongoing monitoring.

The delisting of this colorant reflects evolving regulatory standards and the FDA's continuous re-evaluation of food additives. Color additives are subject to rigorous review processes, and the FDA maintains the authority to revoke approvals if safety concerns emerge or if scientific evidence warrants reconsideration.

Comprehensive published studies specifically evaluating FD&C Violet No. 1's safety profile are limited in the public domain. The regulatory decision to delist this colorant would have been based on FDA's internal safety assessments and scientific review of available data at the time of delisting. The specific scientific rationale for the delisting decision is not widely detailed in readily available literature.

For researchers or regulatory professionals seeking detailed information about the delisting rationale, FDA's Color Additives Status List and associated technical documentation would provide authoritative regulatory context, though the original safety assessment data may have varying levels of public accessibility depending on when the delisting occurred and information disclosure policies in effect at that time.