Hello, hope to find all of you well. Been on a hiatus for several months as the politics and general existential situation here in the USA has been tumultuous, to say the least.
In any event, after reviewing the PMTA’s (from a definite layman’s point of view) https://www.fda.gov/media/127853/download, I can’t seem to make heads or tails out of how and if these regs (kicking in September) are going to affect retail availability of nicotine base? With VaperTec going out of business, I’m thinking perhaps others might follow? If anyone has a definitive answer it would be appreciated. - regards
From what I can make of it, we may loose several small businesses who are trying to do e liquid or flavor manufacturing, they will not be able to cope with the requirements.
on P 41 this about flavors:
VII. ADDITIONAL RECOMMENDATIONS FOR PREMARKET TOBACCO
PRODUCT APPLICATIONS FOR E-LIQUID PRODUCTS
B. Flavors
Because of the potential impact of flavors on product toxicity and appeal to youth and young
adults, scientific reviews of flavors (e.g., toxicological analyses of flavor additives, chemistry
analyses, clinical studies, literature reviews), should be included in a PMTA for an e-liquid.
There may be significant differences in the health risk of flavors depending on their route of
exposure as well as the formation of additional chemicals due to heating or burning of the
flavors. Substances that are generally recognized as safe (GRAS) under sections 201(s) and 409
of the FD&C Act (21 U.S.C. 348) are defined as substances that are intentionally added to food
and intended for oral ingestion. E-liquid is not food or intended for oral ingestion; therefore, the
fact that some substances have been designated GRAS for food does not mean that they are safe
for inhalation.
Under section 910(b)(1)(A) of the FD&C Act, you must include in your PMTA full reports of all
information, published or known to, or which should be reasonably known to you (the applicant)
concerning investigations that have been made to show the health risks of the new tobacco
product and whether the new tobacco product presents less risk than other tobacco products.
FDA considers the appeal and use of ENDS product flavors important in ascertaining the health
risks of these products. In this regard, FDA recommends that you describe research on flavor
development including, but not limited to, market segmentation analysis or sensory testing. You
should describe consumer perceptions among current ENDS users and other tobacco users for
appeal and use intentions based on labeling and actual use of flavors, and product design. In
addition to the recommended information contained throughout this guidance, it is also important
for PMTAs for flavored products to examine the impact of the flavoring on consumer perception
(see section VI.H.2.b.i, above, for a discussion of consumer perception evaluations), especially
given the attractiveness of flavors to youth and young adults. Additionally, to provide a better
understanding of the appeal of flavors to adults, FDA recommends examining adult appeal of
such flavors in their decisions to initiate use, cease use of more harmful products, or dual use.