Cosmetics Editing and Proofreading Services

Fragrance is one word on a label standing for ingredients the label does not name. Under 21 CFR 701.3(a), the label of a cosmetic declares the name of each ingredient in descending order of predominance, "except that fragrance or flavor may be listed as fragrance or flavor."¹ Since December 2022 the same product has also filed an ingredient list with the Food and Drug Administration, under a clause drawn differently. Reading the two together is the first thing worth doing to a cosmetic's copy.

The listing clause names what the panel may compress

The Modernization of Cosmetics Regulation Act added a product listing. Under 21 U.S.C. 364c(c)(4)(A)(iv), each listing includes "a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors."² The clause continues, "with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations," or by the ingredient's common or usual name.² Fragrances, flavors and colors are named expressly, which the labeling rule does not do. The same clause then points back to 701.3 for how each ingredient is named, and 701.3 is the section carrying the label exception.

Those two halves pull against each other inside one sentence, and neither provision says how the sentence resolves. What is clear is that a third route runs to the same information. Section 364a(f) reaches a fragrance or flavor ingredient the Secretary has reasonable grounds to believe caused or contributed to a reportable serious adverse event.³ The Secretary may then request in writing "a list of such ingredients or categories of ingredients."³ The responsible person ensures the information is submitted within 30 days of the request.³

The name on the package becomes a key

What the name may be is loosely drawn. Under 21 CFR 701.11, the principal display panel bears a statement of identity as one of its principal features, in terms of one of three things.⁴ The first is the common or usual name.⁴ The second is an appropriately descriptive name, or where the nature of the cosmetic is obvious "a fanciful name understood by the public to identify such cosmetic."⁴ The third is "an appropriate illustration or vignette representing the intended cosmetic use."⁴

The listing then takes that name as it stands. Section 364c(c)(4)(A)(ii) requires the listing to give the name and contact number of the responsible person, and "the name for the cosmetic product, as such name appears on the label."² A fanciful name chosen by a marketing department becomes the string a federal filing carries. The listing's own identifier is separate, being "the product listing number, if any previously assigned by the Secretary."²

The label is also the return address

Section 364e(a) requires each cosmetic product to bear a label including "a domestic address, domestic phone number, or electronic contact information," through which the responsible person can receive adverse event reports.⁵ Section 364a(d) says the same thing from the other end, providing that the responsible person receives those reports through the contact information included on the label.³ The line is not decoration, and what arrives there starts a clock.

A serious adverse event report goes to the Secretary "no later than 15 business days after the report is received by the responsible person."³ It is "accompanied by a copy of the label on or within the retail packaging of such cosmetic product."³ New and material medical information received within a year of that report goes in on the same schedule.³ Records of adverse event reports are kept six years.³ The period is three years for a responsible person that is a small business under section 364h and does not engage in the manufacturing or processing of the products that section describes.³

What counts as serious is defined, and the definition is long

The term is not left to ordinary usage. A serious adverse event is one resulting in death, a life-threatening experience, or inpatient hospitalization.⁶ The list continues with "a persistent or significant disability or incapacity," "a congenital anomaly or birth defect," an infection, and significant disfigurement other than as intended.⁶ The disfigurement item carries its own parenthesis, taking in "serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance."⁶

A further branch of the test reaches events short of those outcomes. It covers an event that "requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A)."⁶ Reasonable medical judgment is written into the threshold, so the question of what is serious is a medical one before it is a drafting one.

The toxicologist's file, and the copywriter's page

Safety substantiation sits with the responsible person and its own experts. Confidentiality applies to every document we receive. Nobody here decides that a product is safe, that an event is serious, or that a substance belongs on an ingredient list, and none of the three is answerable from the copy.

Agreement between the documents is what shows on the page. Where a panel gives the product one name and the listing gives it another, the two names are there to be counted. Where a panel says fragrance and the filing carries a longer entry, the difference is a difference in text, and which one is right belongs to the responsible person. A contact line names an address, and whether the company monitors that address is a question we raise rather than answer.