FDA Update on FDA Authority for Tobacco Products

The Food and Drug Administration (FDA) released another guidance for "small entities."


The link can be found here: https://www.fda.gov/media/97664/download


Let's start with definitions. These definitions can be found at the link provided above.


Tobacco product: any product made or derived from tobacco that is intended for human consumption, including any component, party or accessory.


Accessory: any product that is intended or reasonably expected to be used with or for the human consumption; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended to affect or alter the performance, composition, constituents or characteristics (2) is intended to affect or alter the performance, composition, constituents or characteristics but (a) solely controls moisture and/or temperature of stored tobacco products or (b) solely provides an external heat source to initiate but not maintain combustion of a tobacco product.


Component or part: any software or assembly of materials intended or reasonably expected to (1) alter or affect performance, composition, constituents, or characteristics or (2) used with or for human consumption of a tobacco product.


What does all of this mean?


This means that organic cotton, the little blue screwdrivers your get with RDAs/RDTAs/RTAs, scissors, wire (Kanthal, Stainless Steel, Nickel, NiChrome, Titanium, etc.) are all considered components or accessories. This also goes into lanyards, silicone covers, drip tips (mouth piece), clearomizers, sub-ohm tanks, coils/atomizers, e-liquids, batteries (with or without variable voltage/wattage), flavors and programmable software are all considered accessories, components or parts, and are deemed tobacco products.


The next section goes into labeling and advertisements. Here are the guidelines:


For labels:


1. All labels must contain the following phrase: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

2. This must be in 12 point font. The font must be Helvetical or Arial Bold.

3. This warning must be in black text with a white box, or white text with a black box.

4. Must occupy 30% of each panel of the label.


For advertisements:

1. Must be on the upper portion of an advertisement, and occupy 20% of the area.

2. This must be in 12 point font. The font must be Helvetical or Arial Bold.

3. This warning must be in black text with a white box, or white text with a black box.

4. Rectangular border that is at least 3mm in width but no more than 4mm in width that is the same color as the text.


Next we have discussion about age and identification restrictions. This section states that covered tobacco products are subject to age and ID requirements that prohibit the sale of products to people under the age of 18 and require verification via photo identification, except for any person over the age of 26.


This portion is quite confusing as the minimum age to purchase covered tobacco products was raised to 21 on December 20th, 2019. This document was updated several times, with the most recent update being in April of 2020. Also, the exception for any person over the age of 26 seems to be a bit relaxed, as there are people like myself who can look 12 or 30. This is just overwhelmingly confusing.


Let's move forward.


The Pre-Market Tobacco Application (PMTA) was due on May 12th, 2020, but due to COVID-19, there was an extension given and the new date is September 9th, 2020. This gave a mere 120 days for companies to complete and submit the PMTA for their products.


The next section makes me giggle, because it makes the FDA sound like they are trying to help small entities, but they really aren't.


There is "targeted" relief for small-scale tobacco product manufacturers, which means they employ less than 150 full-time employees and has a total annual revenue of $5,000,000 or less. Yes, you read that correctly, five million dollars or less. They go on to discuss the various "reliefs" such as the SE Extension request, Tobacco Health Document Submission and the utilization of the Center of Tobacco Products phone number.


There you have it. Of course, the article is linked at the top, please read through it for more examination and understanding.


Be safe, be healthy.


~Mik

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