FDA Big news coming out of FDA

[Lessifer]

There is a whole world of legal difference between:
"Using Nutricigs will cause you to eat less and lose weight."
and
"Try Nutricigs. Eat less, lose weight, feel great."

 

[Oliver]

I tell you, companies like that seriously depress me.

I have absolutely no problem with people wanting to inhale supplements, and for people to want to sell them. But this kind of marketing is just hideous.

 

[Katya]

No - this is all marketing - including "circumstantial evidence" that therapeutic claims are being made.

So, if you run a B&M and help your customers to transition to vaping, you better watch out.

As a supplement, isn't all they need this particular line?: *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

It did seem that they were pretty careful with their "claims" and how they are worded.

I have a suggestion to all e-cig vendors: Put a huge disclaimer on your website or inside your store that says,

This product is not intended to diagnose, treat, cure or prevent any disease nor has it been approved by the FDA.

However, Mitch Zeller, J.D., Director of the FDA's Center for Tobacco Products, has stated the following:

"If we could get all of those people [who can't or won’t quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."

"It is not the nicotine that kills half of all long-term cigarette smokers. The nicotine creates and sustains the addictions, but it's not the nicotine that kills people."

 

[stevegmu]

Honestly, I don't actually know. Can they simply disclaim away medical claims like that?

A tag line doesn't absolve them in this case. Their e-cigs are making claims supplements can claim, but they are a tobacco product according to the FDA. Tobacco products can't make claims supplements can, at least not once this rule passes....

 

[Oliver]

I can pretty much guess Nutricigs next move: Ditch the nicotine.

 

[Lessifer]

A tag line doesn't absolve them in this case. Their e-cigs are making claims supplements can claim, but they are a tobacco product according to the FDA. Tobacco products can't make claims supplements can, at least not once this rule passes....

I haven't read all of their website yet, but I think they're actually saying that the nicotine IS the supplement as it is a natural appetite suppressant, energy booster, not sure about sleep aid though...

 

[f1vefour]

I haven't read all of their website yet, but I think they're actually saying that the nicotine IS the supplement as it is a natural appetite suppressant, energy booster, not sure about sleep aid though...

We all know how well stimulants help you sleep :/

 

[stevegmu]

I haven't read all of their website yet, but I think they're actually saying that the nicotine IS the supplement as it is a natural appetite suppressant, energy booster, not sure about sleep aid though...

What precedence is there for these claims? Has Phillip Morris or chewing tobacco brands made these claims in the past and marketed their products like this?

if the product is intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

 

[Oliver]

"commonly" < does this word have a legal definition?

Probably there's discussion of it during B&W, if it did occur. Reasonably sure I remember weight loss claims in ads from the 1950s.

 

[Lessifer]

What precedence is there for these claims? Has Phillip Morris or chewing tobacco brands made these claims in the past and marketed their products like this?

if the product is intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

I didn't say it was a good plan. However, if e-cigs weren't poised to be deemed tobacco products, I think they would actually be okay with possibly some minor adjustments to their copy.

Here is copy from an actual weight loss supplement:

Every supplement PERFORMIX makes is driven by a common technology: best in class absorption, time released delivery and complete use of every single molecule…period. TERRA Pod Suspension delivers the nutrients you need to dominate your goals. To out perform, out last and out do.

TERRA Coating (™) is a micro layering technology that allows each dose to be released in PH activated stages. This creates precision delivery of our pure extracts at multiple calculated points when your body is receptive. As your stomach acid dissolves each microlayer, perfectly timed nutrients are delivered, giving our extracts the ability to last longer and enhance your performance evenly and effectively.

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

 

[stevegmu]

"commonly" < does this word have a legal definition?

Probably there's discussion of it during B&W, if it did occur. Reasonably sure I remember weight loss claims in ads from the 1950s.

Perhaps, but how can they defend this?


NutriCigs Support Boosting energy while giving the ability to enjoy an invigorating electronic cigarette without the calories, carbs, sugar or sudden crash!*

• Energy Without The Crash, Or Having To Stomach One More Bad-Tasting Energy Drink!*
• Supports Natural Energy Whenever Your Body Cries For It!*
• Disposable, Fortified E-Cigarette; A More Useful Electronic Cigarette
• Many Experts Believe That Vapor Allows The Body To Absorb & Utilize Ingredients Easier!
• 3 Tasty, Vivacious Flavors: Tobacco, Menthol, & Cherry
• 1.8% Nicotine by Volume

 

[Katya]

They are trying to change the definition of "therapeutic claims" from how I read it.
They are trying to make "intended use" a therapeutic claim, even though Judge Leon already shot that down.

How on earth can anyone legally ban "intentions" ???? Can you ban spoons, razors, tin foil, small mirrors, drinking straws, etc. because some people intend to use them in preparation of illicit substances?

 

[Lessifer]

 

[Lessifer]

Perhaps, but how can they defend this?


NutriCigs Support Boosting energy while giving the ability to enjoy an invigorating electronic cigarette without the calories, carbs, sugar or sudden crash!*

• Energy Without The Crash, Or Having To Stomach One More Bad-Tasting Energy Drink!*
• Supports Natural Energy Whenever Your Body Cries For It!*
• Disposable, Fortified E-Cigarette; A More Useful Electronic Cigarette
• Many Experts Believe That Vapor Allows The Body To Absorb & Utilize Ingredients Easier!
• 3 Tasty, Vivacious Flavors: Tobacco, Menthol, & Cherry
• 1.8% Nicotine by Volume

I'm guessing the claims that you have a problem with are the ones that include the word "Support," and I'm also guessing that including that word makes it not a claim of treatment.

 

[stevegmu]

I didn't say it was a good plan. However, if e-cigs weren't poised to be deemed tobacco products, I think they would actually be okay with possibly some minor adjustments to their copy.

Here is copy from an actual weight loss supplement:

Nicotine is key here... The proposed rule specifically states nicotine must have been commonly marketed to have the same effects as the new tobacco product in question...

 

[stevegmu]

How on earth can anyone legally ban "intentions" ???? Can you ban spoons, razors, tin foil, small mirrors, drinking straws, etc. because some people intend to use them in preparation of illicit substances?

I have 'paper weights' the exact size, shape and weight of brass knuckles. They are not legal in some states- as paper weights, or brass knuckles...

 

[f1vefour]

I'm pretty sure there are preexisting studies that prove nicotine is an appetite suppressant.

 

[DC2]

I'm pretty sure there are preexisting studies that prove nicotine is an appetite suppressant.

Yes indeed there are.

But not FDA approved for that purpose as far as I know.
And that's all that matters here.

Sadly.

 

[stevegmu]

I'm pretty sure there are preexisting studies that prove nicotine is an appetite suppressant.

That doesn't make a difference with the proposed ruling. A company must have commonly marketed cigarettes or chewing tobacco as having these health benefits. A poster or even video won't pass muster and certainly not studies...

 

[f1vefour]

Yes indeed there are.

But not FDA approved for that purpose as far as I know.
And that's all that matters here.

Sadly.

Ah ha, not FDA approved is the definitive issue. I'm surprised since obesity is rampant in the States.