New FDA E-Cigarette Regulations Coming

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New FDA E-Cigarette Regulations Coming

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 labeled with health disclaimers about the nicotine content.

Now what?

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 a way 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 into 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 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 compliance with cGMPs can be 

expensive and time-consuming. 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 a task.

InstantGMP understands small businesses’ needs and provides software solutions for e-liquid manufacturers facing regulations. Our software
is intuitive and 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.

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