FAQs

Q?

What do I need to start PMTA?

A.

Contact one of our associate to schedule a phone call to discuss specific plan for your company to comply with the new FDA rule.

Q?

Is there any published cGMP for Tobacco Manufacturers?

A.

FDA has not published any guidelines to which manufacturer establishments will adhere to. FDA will published a cGMP guidelines similar to the cGMP for pharmaceutical, medical devices and dietary supplement. Some of these guidelines may address the following:

1- Inspection and testing of raw materials and components.

2- In-process and finished product testing.

3- Product development, design control and validation.

4- Establish and validation of manufacturing processes.

5- Quality Audit and Inspection.

6- Nonconformance and Corrective Actions.

7- Equipment maintenance and calibration.

8- Document and record control and retention.

9- Supplier Quality Audit and Qualification.

10- Customer complaint and product recall.

Q?

What is the deadline to comply with labeling requirement?

A.

All manufacturers and importers must comply to the labeling guideline by May 08, 2018.

Q?

What is the deadline to submit PMTA?

A.

There is no deadline to submit PMTA but it is strongly recommended to start the process as soon as August 08, 2016. You should consider that your application must be submitted and approved within 24 months.

Q?

What is the deadline to comply with FDA final Rule?

A.

All products should be comply to the Final Rule of FDA by May 08, 2018. After that date, all products that do not comply to the new rule, must withdraw from the marketplace by that date.

Q?

What is “Grandfather” Product and what is the chances that my products consider under this rule?

A.

“Grandfather”: are Products sold in the market before and ON February 15, 2007

FDA does not anticipate that many manufacturers will make such submissions, but this option is available.

Q?

What are my options for product submission to FDA?

A.

A manufacturer and importers are required to submit their products in one of the following three options:

1- Substantial Equivalence

If you product or similar one was commercially marketed after February 15, 2007 but

2- Exemption from Substantial Equivalence

A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence.

3- Premarket Tobacco Applications

Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product.  To issue an order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product on the population as a whole, including tobacco product users as well as non-users.

Q?

When does the final rule of the FDA 21CFR 1100 go into effect?

A.

Starting on August 08, 2016, the final rule of FDA Part 21CFR 1100, 1140 and 1143 will go into effect.

Q?

Can I introduce a new product anytime after August 08, 2016?

A.

No, you cannot launch a new product to the market after August 08, 2016. You must submit PMTA to the FDA and must receive the FDA approval before introducing a new product to the marketplace.

Q?

What is the deadline to register my manufacturing facility?

A.

You must register your manufacturing facility with the FDA by December 31, 2016.

Q?

What is the deadline to submit a list of products and ingredients list?

A.

You must submit the list of products and ingredients by December 31, 2016.

 

 

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