TruVision FDA warning

Department of Health and Human Services	Food and Drug Administration
	5100 Paint Branch Parkway College Park, MD 20740

WARNING LETTER

SEPT 21, 2015 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

Derek Bailey, Founding Partner

Shawn Gibson, Founding Partner

Travis Martin, Founding Partner

TruVision Health LLC

12244 S Business Park Drive

Ste. 115
Draper, UT 84020-6522 US

Re: 461315 

Dear Mr. Bailey, Mr. Gibson, Mr. Martin and:

This letter concerns your product tru Weight & EnergyTM, which is labeled and/or offered for sale as a dietary supplement. The Supplement Facts panel on your product label appears to declare AMP as a dietary ingredient. This ingredient is also called, among other names, 1,3-Dimethylbutylamine, DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.  In addition, the Supplement Facts panel on your product label appears to declare Bitter Orange Extract (synephrine 30%) as a dietary ingredient. 

The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(ff)). Given that you appear to declare DMBA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMBA is a “dietary ingredient” under section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)). Assuming that DMBA is a “dietary ingredient,” it would also be a “new dietary ingredient” for which a notification is required under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6.

Under section 413 of the Act (21 U.S.C. 350b), a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act (21 U.S.C. 342(f)) unless it meets one of two requirements:

1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

DMBA

To the best of FDA’s knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, DMBA is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).

Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under sections 301(a) and (v) of the Act (21 U.S.C. 331(a) and (v)). To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient. 

It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced DMBA is not commonly used as human food or drink. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of the preceding categories. Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.

Bitter Orange Extract (synephrine 30%)

Bitter orange (C. aurantium) is a dietary ingredient under sections 201(ff)(1)(C) and 201(ff)(1)(E) of the Act and has a history of use by man intended to supplement the diet. However, the levels of synephrine in Bitter Orange Extract (synephrine 30%) have been modified from naturally occurring levels. The natural p-synephrine content in dried bitter orange ranges from 0.012%-0.25%[1] and the content of p-synephrine in concentrated extracts or commercial products are standardized to 4-6%[2],[3],[4]. 

To the best of FDA’s knowledge, there is no information demonstrating that Bitter Orange Extract (synephrine 30%) was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, Bitter Orange Extract (synephrine 30%) is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).

Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%), when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, your tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%) will reasonably be expected to be safe when used as a dietary ingredient. In fact, there is evidence from short term human and animal studies suggesting that the consumption of products containing a high dosage of bitter orange extract and synephrine could lead to a significant increase in systolic blood pressure, diastolic blood pressure, and heart rate.  Similarly, products containing Bitter Orange Extract with high doses of p-synephrine and caffeine, also an ingredient in your product may be of potential safety concern. The combination of these substances is likely to enhance their potential cardiovascular effects and could contribute to a significant increase in heart rate and blood pressure[5].

We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your tru Weight & EnergyTM product or other dietary supplement products marketed by your firm, including any that contain DMBA and/or Bitter Orange Extract (synephrine 30%). We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

Failure to immediately cease distribution of your tru Weight & EnergyTM product and any other products you market that contain DMBA and/or Bitter Orange Extract (synephrine 30%) could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 

We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Mr. Rob Genzel, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Genzel atrob.genzel@fda.hhs.gov.

Sincerely,

/S/                                                                                               

William A. Correll

Director

Office of Compliance

Center for Food Safety

  and Applied Nutrition

---

Taken from a message sent to me, as posted via TruVision Health Office:

TruVision Health is committed to the highest levels of efficacy and safety in our product offering. Recently, an ingredient present in our TruWeight & Energy, AMP Citrate, has recently come under scrutiny by the FDA. While we believe this to be a safe ingredient in our formula, we also recognize the FDA’s authority to regulate the availability of ingredients.

There are many ways to formulate products to bring about an intended result. Even if AMP Citrate is eventually made unavailable, David Brown is already in posession of the next generation formula that will provide our customers the same or superior level of efficacy that our associates have come to expect from our products. Shortly we will begin phasing out the current Weight & Energy and phasing in the next generation Weight & Energy. We are committed in striving to continue to make a difference in the war against obesity.

The responses thus far:

"Well this happened to another company right after I started taking there product and the new one didn't do the job the old one did. So not sure I am happy about this ( hope it is better guess we will see)"

"That's how I feel..when the other product changed it up I didn't have any results. Just weight gain  hope this change is a good one. Because I love the products now."

"What about the product we still have? Is the product still safe to take?"

"Another product line did the same thing and the 2nd generation was not as effective. I hope this works."

"Guys, I am SO EXCITED!!! I can tell you that we are in GREAT hands! Dave Brown and Corp is so ahead of the game! Trust us when we tell you that if you liked the original formula, you will LOVE this Generation 2! smile emoticon Stay tuned bc more GREAT info is coming soon!!! If you think things have been good...we are about to take things to a NEW LEVEL!!! grin emoticon I am so proud to be a part of this company and completely trust our founders and Dave Brown!! Great things ahead everyone!!!"

"So is the current Truweight safe to take???"

"That is so strange that you posted this. I was just at my doctors and the only ingredient he was concerned about was the Amp."

"This has been coming and it did not take our leaders by surprise. Dave has been preparing for it from the beginning!!! The new generation of truweight and energy will be even better than the original!!! I'm very excited!!!"

"I'm not worry.. Dave Brown will take care of us"

People, get your heads screwed on straight.
You will be told what you want to hear in order for these people to continue to have an income.
Nobody in their right mind from the company is going to tell you that they include AMP as that is the only ingredient that does anything. It acts like speed, meth and the like.

Dave Brown, what a joke. He just regurgitates what he finds on google.