The Responsible Person
Every product sold in the United States requires that the label includes the business name and address of the manufacturer, packer or distributor of the product.1 The business named on the label is considered the “responsible person” for the product.
Person, in this case, can be an actual person or a business, firm, or association.
If you make and sell products with your own name on the label, you are both the manufacturer and the responsible person.
However, if you make products for someone else and their name is on the label, then you are the manufacturer and the person whose name is on the label is the responsible person. In that case, the label should be clear that the product was “manufactured for …” or “distributed by …” the responsible person to show that they didn’t actually make the product.
Cosmetics
With the passage of The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) there are some some specific requirements and obligations for the responsible person which are separate from the requirements and obligations of the manufacturer.
If you manufacture and sell under your business, then you have these responsibilities.
However, if you make a product for someone else and their name is on the label, that person has these responsibilities.
1. Serious Adverse Event Reports
The responsible person must submit a report of any serious adverse events that occur which are associated with a cosmetic product.
The responsible person must also keep the records for serious adverse events and make them available to the FDA if requested.
If the FDA thinks that there were ingredients in a flavor or fragrance that caused or contributed to a serious adverse event, they can request the ingredient list. If you make products for someone else, it’s likely they would come to you, as the manufacturer, to get that information. You would need to get that data from your supplier.
2. Product Listings
Unless the responsible party is exempt as a small business, they must submit product listings for all the products they sell. It doesn’t matter if the manufacturer is exempt.
If the responsible party doesn’t actually manufacture the products, they will need information from the manufacturer to complete the registration process.
If you are exempt as a small business but you manufacture products for a larger company that is NOT exempt, they will have to register the products with the FDA. You will be noted as the manufacturer, but don’t have to actually register your facility if you don’t want to.
3. Safety Substantiation
Surprisingly, it is the responsible party (not the manufacturer) that is required to have safety substantiation for a cosmetic product they sell.4
If you manufacture and sell your own products, then you are both the responsible party and the manufacturer, and therefore should have the safety substantiation.
If you manufacture products for someone else, then you will likely need to provide them with safety substantiation documentation or be able to do so if they request the information.
4. Adverse Event Contact Information
The business name and address on the label serves as the contact information for a consumer to report an adverse event.
If the full street address is not on the label,5 some alternate form of contact is required. It may be an email, phone or website.6
5. Fragrance Allergens
The responsible person must include include any fragrance allergens in the ingredient declaration (once the list is issued by the FDA).7
If you manufacture products for someone else, you will need to provide ingredient and fragrance allergen information to them so they can correctly label the product.
6. Records
Both the responsible person and the manufacturer must provide any records or documentation of the FDA if requested.8
7. Recalls
In the event of a serious issue with a product, the FDA may request a recall or issue a mandatory recall. The order would go to the responsible person, who would be responsible for conducting such a recall.
1 Fair Packaging and Labeling Act, 15 USC 1453(a)(1)
2 Fair Packaging and Labeling Act, 15 USC 1459(d). See also Wikipedia Legal Person
3 This is a common practice and is usually referred to as white label, private label, or contract manufacturing depending on the arrangements made.
4 21 USC 364d
5 The street address may be omitted if it is included in an online or print phone or city directory; the city, state and zip code are always required.
6 21 USC 364e(a)
7 21 USC 364e(b)
8 21 USC 364f
