In a recent confidential letter sent to Outlaw Dip Co. - The FDA Responds and updates their status on the use(s) of the ZERO NICOTINE Alternative called Nic-Safe™. We wouldn’t live up to our name of OUTLAW’s if we didn’t share these confidential results with you! (Or at least what we can!)
Now, before we dive in to the meat and potatoes; What is Nic-Safe™ for those who don’t already know?
In short:
Nic-safe™ (Nixamide) is made from a proprietary alternative solution to nicotine (patent pending.) Made from natural b3 vitamins, Nixamide has been specifically formulated to deliver the same satisfaction, pleasure, and enjoyment as traditional tobacco and nicotine products. Giving you the buzz that Alternative Nicotine users crave and turn to when they need to lay off the nicotine.
Read more about Nic-safe and its properties, and how it works here.
Now on to the main point: The recent Letter sent to Outlaw Dip Co. The FDA OFFICIALLY responds to the use of Zero Nicotine Nixamide. Stating -
“…we have no hesitation in providing our opinion that Nixamide™ is not a “tobacco product” as defined in the Food, Drug and Cosmetic Act (“FDCA” or the “Act”), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”) and the Consolidated Appropriations Act of 2022 (“CAA”).1.”
Let’s take a deeper look into The FDCA Section 201 File so we can better understand what this means…
"Under FDCA Section 201(rr)(1), 21 U.S.C. § 321(rr), a tobacco product “means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” The statute further provides that a tobacco product does not mean (1) a drug under Section 201(g)(1) of the Act, a device under Section 201(h), or combination product as described in Section 503(g); or (2) an article that is a food under Section 201(f) if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine."
Now that we’re up to speed about what the FDA Considers a “NO-NO,” Lets take a look at the facts of what Nixamide is and why the FDA WILL NOT REGULATE it -
- Nixamide™ is a proprietary blend of nicotinamide (CAS Reg. No. 98-92-0) and either vegetable glycerin (“VG”), propylene glycol (“PG”), or combinations thereof.
- In the TCA, “nicotine” is defined by its International Union of Pure and Applied Chemistry (IUPAC) name and chemical formula as the “chemical substance named 3-(1-methyl-2- pyrrolidinyl)pyridine, which has a molecular formula of C10H14N2, including any salt or complex of nicotine.” See 21 U.S.C § 387(12). - Watching Bill Nye the Science Guy did not prepare me for this information…
- None of the Nixamide™ ingredients are made or derived from tobacco or nicotine, or use tobacco or nicotine as a starting substance. Specifically, no form of nicotine, including S-(-)- nicotine (CAS Reg. No. 54-11-5), R-(+)-nicotine (CAS Reg. No. 25162-00-9), or racemic-(±)- nicotine (CAS Reg. No. 22083-74-5) is used as an ingredient of Nixamide™ or used in the synthesis of Nixamide™ or any of its ingredients.
- Analytical test results have confirmed that nicotine is not present in Nixamide™ at an appropriately sensitive limit of detection.
As Alex Jones says (not to get all BLACK HELICOPTERS on ya’…)
WE HAVE THE DOCUMENTS!
This is Great News for Outlaw Dip Co. and our loyal customers. A Solid win that ensures our way of bringing you quality Non-Tobacco Non-Nicotine alternatives remain intact without BIG BROTHER stepping in and regulatin’ the regulators. Many of you have tried our Nic-Safe™ options and we’ve had amazing feedback so far.
“A nice warm hug,”
“The Buzz is Great,”
”I use Nic-Safe™ to quit nicotine FOR GOOD!”
…are just some of the reviews we’ve gotten when it comes to Nic-Safe™ and our Non-Nicotine Alternatives!
Be sure to check out some of our flavors and options and form your own opinion!
Shop Now at OutlawDip.com
