Retinyl Palmitate Update by Dr. Mike Buch
Retinyl Palmitate update from Dr. Mike Buch, Chief Scientist at Young Living:
I want to provide an update to my previous communication regarding retinyl palmitate (Vitamin A - palmitae). As part of our continuous improvement program, R&D and Product Management teams prioritize new product development along with product updates (reformulations/packaging changes etc.) as part of a standard product lifecycle management process.
Product reformulations are complex and require significant resources, time and effort. It’s not as simple as just “removing an ingredient.” Sometimes packaging and manufacturing equipment need to be changed as part of minor reformulations. International compliance and registrations are also evaluated as part of any product change. A typical reformulation phase is about 8-12 months followed by the testing phase, which requires about 5 months.
I had hoped to have all reformulations completed by the end of last year but this simply wasn’t possible due to the complexity of the formulations. Quite frankly, with limited resources, we needed and continue to prioritize reformulation and new formulation work, and for the scientific reasons outlined below, removal of retinyl palmitate, which is a form of vitamin A, was not a top priority for us because of its overall safety profile.
I do want you to know that we’ve heard your concerns regarding the safety of retinyl palmitate and I’d like to address these concerns from a scientific perspective.
R&D, Product Safety, and Regulatory Affairs have been carefully reviewing the toxicological, in-vitro, and in-vivo studies that were published on Retinyl Palmitate (Vitamin A -palmitate). In our extensive research of over 100 peer-reviewed scientific articles, we have not found any scientifically valid information on safety concerns of retinyl palmitate as a photocarcinogen.
Unfortunately, there was one flawed study which was cited by many bloggers and other private ingredient rating groups like EWG Skin Deep who mis-interpreted the data. It is important to note that this study ONLY referred to retinyl palmitate used in sun screens. The agency (National Toxicology Program - NTP) that performed the study clearly stated that the results should not be extrapolated to humans. The direct quote from the NTP is “extrapolation of these results to other species, including characterization of hazards and risks to humans, requires analyses beyond the intent of these reports.”
Other scientific organizations performed further analyses and found “there is no evidence that the inclusion of retinyl palmitate in sunscreens can cause cancer in humans.”
Skin Cancer Foundation (May 20, 2015):
“Regarding retinyl palmitate -- as the EWG indicates in its 2015 Sunscreen Report -- despite the organization’s own claims, there is no conclusive research finding that this ingredient is hazardous in any way.”
American Academy of Dermatology (Aug.10, 2010):
“Despite previous concerns about the cancer-causing potential of sunscreens containing retinyl palmitate (vitamin A), an independent analysis published online in the Journal of the American Academy of Dermatology (JAAD) determined that there is no evidence that the inclusion of retinyl palmitate in sunscreens can cause cancer in humans.”
The NTP study is scientifically flawed. Although the anatomy of the human skin is completely different than that of hairless mice, the study concludes that application of the control cream (no retinyl palmitate) itself developed skin tumors. It is well-known that hairless mice are highly susceptible to the development of cancer, and, in fact, EVERYTHING tested in this study caused cancer in these mice, including the negative control.
Furthermore, this particular study used unreasonable doses of UV light. Most mice only live for about 6 months in the wild and a bit longer in captivity, so to expose them to 40 weeks of UV light is exposing them to very severe radiation for four months longer than their average lifespan in the wild. This is about like a human spending every day of his or her life in the harshest sun conditions for 120 years.
We are confident that the concentration of retinyl palmitate in YL products is not a safety concern and is well within the limits set by global regulatory bodies.//
Thank you Dr. Mike!!!!