TruVision Health LLC 9/21/15
| Food and Drug Administration |
5100 Paint Branch Parkway
College Park, MD 20740 |
Department of Health and Human Services
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
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
[1] Rossato, L. G.; Costa, V. M.; Limberger, R. P.; Bastos, M. d. L.; Remião, F., Synephrine: From trace concentrations to massive consumption in weight-loss. Food and Chemical Toxicology 2011, 49, (1), 8-16.
[2] Kubo, K.; Kiyose, C.; Ogino, S.; Saito, M., Suppressive Effect of <i>Citrus aurantium</i> against Body Fat Accumulation and Its Safety. Journal of Clinical Biochemistry and Nutrition 2005, 36, (1), 11-17.
[3] Nguyen, D. T.; Bui, L. T.; Ambrose, P. J., Response of CEDIA amphetamines assay after a single dose of bitter orange. Ther Drug Monit 2006, 28, (2), 252-4.
[4] Penzak, S. R.; Jann, M. W.; Cold, J. A.; Hon, Y. Y.; Desai, H. D.; Gurley, B. J., Seville (sour) Orange Juice: Synephrine Content and Cardiovascular Effects in Normotensive Adults. The Journal of Clinical Pharmacology2001, 41, (10), 1059-1063.
[5] Health assessment of sports and weight loss products containing synephrine and caffeine. www.bfr.bund.de
