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].
