E-cigarettes will soon be regulated under tobacco products as a rule proposed by the Food
& Drug Administration (FDA). The rule is currently being reviewed by the
White House Office of Management and Budget’s Office of Information and
Regulatory Affairs. It will be several weeks before the proposed rule is
formally approved and any action is taken.
Up until now e-cigarettes and e-liquids have seen little in
the way of regulations. It won’t be long until E-cigs that were advertised as
being therapeutic will be investigated for their health claims. Things are changing and agencies are concerned about E-cigs being used by minors and about them not being labelled with health disclaimers about nicotine
In addition to providing health and safety disclaimers,
e-liquid manufacturers will have to register their list of ingredients, as well
as other information. The government is still trying to find their way on how
to regulate E-cigs by deeming them tobacco products. Many health organizations
have complained that regulations have been slow in coming and that E-cigs are
getting in the hands of individuals under the age of 18.
Many other industries have to follow strict FDA
manufacturing regulations. For example manufacturers of dietary supplements
have to go through rigorous testing of their ingredients and can
land in serious trouble for failing to establish specifications.
The e-cigarette community has been resistant to regulation,
insisting that they are not a tobacco product and all this is hoopla is for tax
reasons but in reality, it’s to protect the end user and to set up systems for
when something happens and a recall is necessary.
Small businesses that produce these products are concerned
about regulations because coming into compliance with cGMPs can be an
expensive and time consuming process. They worry that this will harm the
burgeoning market because only big players can afford to become compliant.
That is no longer true.
There are several steps that a manufacturer must follow in
order to come into compliance with good manufacturing practices (GMPs) and with
the advent of technology, it is possible for a small company to undertake such
InstantGMP understands small business’ needs and provides
software solutions for e-liquid manufacturers facing regulations. Our software
is intuitive, time saving, provides batch organization, and implements GMP
workflows with simplified electronic batch records. If you’re worried about
what’s to come, we are more than capable of helping your company come into
compliance. For more information, click here to view our online demo or contact us.