While many in the industry are wishfully thinking that the FDAs May 2016 “Deeming Rule” will simply go away (including some of my tobacco product and ENDS importer clients), FDAs announcement on December 9, 2016 that it does not intend to enforce the submission deadline of December 31, 2016 for establishment registration and product listings as long as submissions are received by the FDA on or before June 30, 2017, suggests a flexibility and willingness to accommodate the industry in its pursuit of compliance, and not a scrapping of the rule as a whole.
As it remains the current law of the land, more questions have come in to my firm about what this rule even means, starting with the simple question, “What is it?”
To provide some background, on June 29, 2009 the Family Smoking Prevention & Tobacco Act (aka “Tobacco Control Act”) amended the Food Drug & Cosmetic Act (FD&C Act) which gave the FDA the authority to regulate what it defines as “tobacco products,” including, but not limited to,
Smokeless tobacco (e.g., snus), and
Any other tobacco product as decided by the Secretary of Health & Human Services
FDAs position is that Congress authorized it under the Tobacco Control Act to “deem” any tobacco product (except certain raw tobacco leaf) that it “deems fit” to be subject to its regulatory oversight.
As such, in its “deeming rule,” which went into effect on August 8, 2016, the FDA broadened the term “tobacco product” to also include components, parts, or accessories of tobacco products (whether sold for manufacturing or consumer use) including a number of products that contain no tobacco, like
It further specified a distinct category of products known as Electronic Nicotine Delivery Systems (“ENDS”), which include
E-liquid and aerosolizing apparatus used as an ENDS (i.e., the electronic device that delivers e-liquid in aerosol form into the mouth and lungs when inhaled)
Therefore, under the FDAs regulations there are now mandatory compliance procedures which must be undertaken in advance of selling any of the tobacco products listed above, with variations occurring where the product
Is completely new to the market,
Was already on the market prior to August 8, 2016, or
Was already on the market prior to February 15, 2007 (the “grandfather date”),
and depending on the size of the enterprise at issue, the deadlines for compliance with the new rules also vary.
While certain labeling and registration obligations are now mandated, the “big issue” with this rule is the requirement to obtain a pre-marketing authorization from the FDA in advance of marketing, i.e., offering to sell or selling, the product in the United States.
Do you sell these products but are unfamiliar with your compliance obligations? Read more in our article entitled “FDAs Deeming Rule on Vape & Tobacco Products: Who is It Applicable To?” which can be found here.
Have questions about the scope of the rule and its impact on your business? Feel free to connect with us via the Contact form above.