Alternative Laboratories, a supplement manufacturer and supplier for several MLM companies, has been issued a warning letter by the FDA.
Alternative Laboratories is based out of Florida and operated by CEO Kevin Thomas.
Among other products, Alternative Laboratories manufactures
- Elevate Smart Coffee, Choclevate and Elevate Nitro for Elepreneurs (formerly Elevacity) and
- SlimRoast Optimum Dark Roast Coffee and SlimRoast Optimum Cocoa for Valentus.
As per a September 18th FDA warning letter, the regulator recently conducted an inspection of Alternative Laboratories’ Florida based manufacturing facility.
An inspection of Alternative Laboratories’ product labels revealed the
ingredient 2-amino-5 methylheptane and Octodrine as a dietary ingredient in … Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa.
2-amino-5 methylheptane and Octodrine, better known as DMHA, is not approved for use in dietary supplements in the US.
We also note that we have questions about whether DMHA is, in fact, a dietary ingredient.
If DMHA were not a dietary ingredient under section 201(ff)(1) of the Act, it would be an unsafe food additive. If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive.
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(C)(i)].
Adulterated foods cannot be legally imported into or marketed in the United States.
On the non-MLM side of things, Alternative Laboratories was also pinged for Green Roads CBD Oil.
This product is labeled as a dietary supplement; however, it cannot be a dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)].
FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) and (ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(i) and (ii)].
FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition.
On an MLM related note, this might be a wakeup call to all the MLM CBD oil companies out there.
The FDA required Alternative Laboratories to notify them within fifteen days of
specific steps that you have taken to correct these violations.
The letter was issued on September 18th so that deadline has come and gone. The current status of Alternative Laboratories’ compliance is unknown.
To the best of my knowledge Elepreneurs and Valentus distributors are still selling products containing illegal ingredients to US consumers.