FDA regulation of tobacco products, named also Deeming, uses many specific terms and indicates many deadlines that differ according to the type and date of marketing of the products.
10 FAQ to our experts to better define the main points about vaping products.
Who and what is regulated by Deeming?
WHO: any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished tobacco product for sale or distribution in the United States.
WHAT: Deeming regulation applies to all tobacco products, including “new” tobacco ones, among which all vaping items and their components and, more generally, electronic devices that release nicotine (ENDS).
A tobacco product is defined as ‘new’ if placed on the US market or modified after February 15, 2007.
I’m a manufacturer and I have products on the US market. How can I comply?
The obligations required by FDA differ on the basis of product marketing date.
The deadlines for required obligations depend on the characteristics of the manufacturer or importer.
You can find more detailed information here.
I’m a manufacturer and I want to market a new product. How can I comply?
To legally sell a new products, a manufacturer must submit an application through one of the three available premarket pathways for each tobacco product and receive marketing authorization from FDA.
Products entering the market after August 8, 2016 are in violation of the law and may be subject to enforcement if marketed without authorization.
Market authorization: how to submit?
There are three pathways for a manufacturer to obtain the authorization from FDA to legally market a new tobacco product in the United States:
1. Premarket Tobacco Application (PMTA)
2. Substantial Equivalence Report (SE),
3. Exemption from the substantial equivalence requirements (SE exemption).
To proceed with pathways no. 2 and 3, the new product to be marketed must have a predicate product, or a so-called ‘grandfather’, that is a product with similar characteristics placed on the market before 15 February 2007.
This means that these two pathways are hardly applicable to vaping products.
The main pathway for vaping products is therefore a PMTA application (Premarket Tobacco Application), that will the base for FDA to evaluate products considering the public health standard before releasing the marketing authorization.
What are the costs associated with submitting an application?
FDA estimated that the average cost for each premarket review pathway are:
1. an SE exemption report = around $1.500;
2. an SE report = from around $3,500 to around $22.700;
3. a premarket tobacco application (PMTA) = under $ 500.000 (around $117.000 to around $466.000).
It is important to know that the costs that will be applied could vary significantly from these estimates, based on the actual requirements that will be set by the new Commissioner S. Gottlieb, who announced a new comprehensive plan for the regulation of tobacco and nicotine.
What is an Health Document?
The Health Document is a dossier that Identifies tobacco products, constituents, ingredients, components, and additives and describes health, toxicological, behavioral, or physiologic effects (include, for example, cell-based, tissue-based, animal, or human studies, computational toxicology models, information on addiction, etc..).
Read here more info on deadlines for this document.
What’s new about labeling?
Beginning August 10, 2018, a warning label statement must be applied on ENDS and nicotine e-liquids packaging:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
Manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States is forbidden for products without warning statement.
This required warning statement must also meet certain requirements, with respect to font, text, size, placement and formatting of the warning statement on the package labels.
HPHC: what is about?
HPHC is a dossier that identifies, for each product, the quantities of Harmful and Potentially Harmful Constituents.
The guidelines for research and quantification of HPHCs in ENDS are currently being defined by FDA.
The product I manufacture is zero-nicotine. Is my product subject to FDA regulation?
The definition of “tobacco product” includes any component, part, or accessory of a tobacco product, i.e. of an ENDS. Zero-nicotine e-liquids may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.
FDA intends to make these determinations on a case-by-case basis.
I’m a supplier who sells to a manufacturer and not directly to consumers. What do I need to comply with FDA’s New Tobacco Regulation?
If your product is sold only to another company for further manufacture, at this time, FDA does not intend to enforce the obligations required (i.e: that you register your manufacturing establishment and list your products, submit premarket applications or submit ingredient listing or health documents).
