Labeling for FDA Deemed Products
Free legal advice is always nice to have. Here is some information about product labeling and the new FDA deeming rules that may be relevant to some readers of this blog. The article on product labeling for ENDS products takes into account the new FDA deeming. It was written By Joy Syrcle and Michelle Corrigan at Stinson Leonard Street, a firm with experience writing warning labels for eciagrettes and accessories.
What Must Manufacturers Do?
Notably, because they will now be regulated as tobacco products, ENDS and component parts cannot be sold or marketed to individuals under the age of 18. They also may not be sold in vending machines, unless the vending machine is in an adult-only facility.
The new regulations also require that manufacturers of ENDS or component parts obtain FDA approval to sell their products, subject to certain exceptions such as a “grandfather” provision that may be applicable to products sold on or before February 15, 2007. Manufacturers must submit a list of ingredients for their products, information on harmful and potentially harmful constituents (HPHCs) and tobacco health documents to the FDA. Furthermore, manufacturers of modified risk tobacco products, such as products advertised as less harmful than other tobacco products, must obtain an FDA order before selling such products.
What Warnings Are Required?
The new rule also requires warnings to be printed on all ENDS and component parts. 21 CFR 1143.3. If the product contains nicotine, the following warning must be placed on all packaging and advertisements:
WARNING: This product contains nicotine. Nicotine is an addictive chemical.
On packaging, the warning area must be a least 30 percent of each of the two principal display panels. The exact language above must be printed directly on the packaging, clearly visible on the two principal display panels of the package, centered in the warning area, and printed in at least 12-point Helvetica bold or Arial bold font. If the packaging is black, the warning must be printed in white. If the packaging is white, the warning must be printed in black. If the packaging is too small to comply with this rule, the warning must appear on the carton or other outer container of the product, or on a tag affixed to the product.
The same warning language must be displayed on all advertisements for the product, including signs, shelf-talkers, Internet Web pages, and electronic mail correspondence. The warning area must occupy at least 20 percent of the area of the advertisement, with the warning text centered in the warning area in at least 12-point Helvetica bold or Arial bold font and surrounded by a rectangular border (between 3 mm and 4 mm) that is in the same color as the warning statement.
