Interestingly, the Mast Bros have an FDA exemption filed which expires 11/05/2016.
The current FDA guidance pasted below, as I thought it might be interesting to some, actually raises some other questions.... Retailer exemption, versus small wholesaler and product type.
Upon reading the rule it appears that sales of more than 100,000 units per year triggers a requirement for the mandated labeling. A lawyer specializing in FDA regs could perhaps argue that each type of bar warrants an exemption as a different item, but personally I think knocking out several hundred thousand bars a year under the same brand name is probably the point at which you will need to start nutritional labeling.
Section 403(q) of the Federal Food, Drug, and Cosmetic Act requires that packaged foods and dietary supplements bear nutrition labeling unless they qualify for an exemption.
Title 21 of the Code of Federal Regulations (21 CFR) 101.9(j)(1) and 21 CFR 101.9(j)(18) outline the requirements for a small business nutrition labeling exemption for foods. The small business nutrition labeling exemption requirements for dietary supplements are outlined in 21 CFR 101.36(h)(1) and 21 CFR 101.36(h)(2).
The nutrition labeling exemptions found in 21 CFR 101.9(j)(1) and 21 CFR 101.36(h)(1) apply to retailers with annual gross sales of not more than $500,000, or with annual gross sales of foods or dietary supplements to consumers of not more than $50,000. For these exemptions, a notice does not need to be filed with the Food and Drug Administration (FDA).
The nutrition labeling exemptions for low-volume products found in 21 CFR 101.9(j)(18) and 21 CFR 101.36(h)(2) apply if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. For these exemptions, a notice must be filed annually with FDA.
If a person is not an importer, and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units.
A "product" is a food or dietary supplement in any size package; which is manufactured by a single manufacturer or which bears the same brand name; which bears the same statement of identity, and which has similar preparation methods.
A "unit" is a package, or if unpackaged, the form in which the product is offered for sale to consumers.
A "firm" includes all domestic and international affiliates.
updated by @powell-and-jones: 04/19/16 07:59:33PM