Page 7 - Toolkit Updated 1.14

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o a d d r e s s r e c e n t i n c r e a s e s i n u n d e r a g e u s e , F D A a n d
C o n g r e s s h a v e t a k e n a d d i t i o n a l p o l i c y a c t i o n s . F o r
e x a m p l e , i n D e c e m b e r 2 0 1 9 , C o n g r e s s p a s s e d
l e g i s l a t i o n t h a t r a i s e d t h e m i n i m u m - p u r c h a s i n g a g e f o r
t o b a c c o p r o d u c t s , i n c l u d i n g v a p o r , t o 2 1 y e a r s . I n
J a n u a r y 2 0 2 0 , F D A i s s u e d g u i d a n c e t h a t o u t l i n e d i t s
e n f o r c e m e n t p r i o r i t i e s f o r v a p o r p r o d u c t s t h a t w e r e o n
t h e m a r k e t l e g a l l y b u t h a d n o t r e c e i v e d F D A m a r k e t i n g
a u t h o r i z a t i o n .

Based on that guidance, FDA has prioritized
enforcement against the following types of vapor
products:

Any flavored, cartridge-based product (other
B l a c k - m a r k e t p r o d u c t s , i n a d d i t i o n t o b e i n g
than tobacco or menthol flavors);
m a r k e t e d i l l e g a l l y a n d i n v i o l a t i o n o f t h e T o b a c c o
C o n t r o l A c t , m a y p o s e a d d i t i o n a l h e a l t h a n d s a f e t y
All other products for which the manufacturer r i s k s f o r a d u l t c o n s u m e r s b e y o n d t h o s e o f a u t h e n t i c
has failed to take (or is failing to take) p r o d u c t s . A c c o r d i n g t o F D A , “ [ a ] d d i t i o n a l r i s k s

p o s e d b y t h e s e p r o d u c t s i n c l u d e t h e p o t e n t i a l t h a t
adequate measures to prevent minors’ access;
t h e y c o n t a i n h a r m f u l c h e m i c a l s o r c o n s t i t u e n t s t h a t
and
a r e n o t p r e s e n t i n o t h e r p r o d u c t s , t h a t t h e y a r e
m a n u f a c t u r e d u s i n g c o m p a r a t i v e l y p o o r q u a l i t y
Any product that is targeted to minors or c o n t r o l s , a n d t h a t t h e y a r e d e s i g n e d i n w a y s t h a t

whose marketing is likely to promote use by f a c i l i t a t e m o d i f i c a t i o n s b y d i s t r i b u t o r s o r u s e r s — a l l
minors. o f w h i c h i n c r e a s e t h e r i s k o f a d v e r s e e v e n t s . ”

F D A a l s o a c k n o w l e d g e d t h e r i s k o f a n i l l i c i t t r a d e o r
B l a c k - m a r k e t v a p o r p r o d u c t s a l s o m a y c o n t r i b u t e t o
“ b l a c k m a r k e t ” i n v a p o r p r o d u c t s a r i s i n g o u t o f t h i s n e w
u n d e r a g e a c c e s s t o t h e e x t e n t t h e y a r e s o l d t h r o u g h
e n f o r c e m e n t p o l i c y b u t m a i n t a i n e d t h a t i t h a s t h e
n o n t r a d i t i o n a l r e t a i l c h a n n e l s , s u c h a s s o c i a l
r e g u l a t o r y t o o l s a n d e n f o r c e m e n t a u t h o r i t i e s t o
s o u r c i n g o r o n l i n e c o m m e r c i a l m a r k e t p l a c e s t h a t
a d d r e s s s u c h p r o d u c t s .
l a c k a g e - v e r i f i c a t i o n r e q u i r e m e n t s .