The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics.
You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream.
Three new warning letters to stem cell cream makers popped up on the FDA site recently to makers Lavian Ltd, Sircuit Skin, and Annemarie Gianni Skin Care LLC.
Lavian markets something called Resurgent Stem Cell Firming Activator, which the FDA referred to as an unapproved drug based on website claims. This product is available all over the web and sells for more than $600/lb.
Sircuit markets Echinacea Stem Cells (Echinacea Angustifolia Meristem Cell Culture), an apparent plant stem cell-based product. Annemarie Gianni Skin Care markets Repair Serum with “vegan stem cells”.
Note that vegan stem cell facials are out there too and seem popular with some celebrities, although not sure what a vegan stem cell really means other than that it is from plants.
Of course the FDA has different branches or centers that handle cosmetic creams and biologics such as stem cells that are injected into the body, but overall the FDA needs more consistency and common sense on evaluating potential risks of stem cell cosmetic creams versus injected unproven cells.
What seems riskier to you, putting a cream on your face with claimed plant stem cells in it or injecting millions of human stem cells into the human body?
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I see your point and that could be a contributing factor. On the other hand, the FDA is fully empowered to regulate HCTP products, the devices used to make the products, and the procedures for administration. All these apply to the interventions sold by the clinics putting them squarely in the realm of FDA authority.
outside this subject, I would be courious to know what the FDA said about neocutis, a cosmetic cream, done from extracts from human fetus …
I can name four companies right off the top of my head that are manufacturing human stem cell based cosmetic products that are sold through distribution networks and on the Internet. I’m sure the there are plenty more and the number is growing.
Paul,
FDA’s legal authority gives it clear jurisdiction over products and their medical claims whereas it has very limited authority over “the practice of medicine.” Physicians have the leeway to practice medicine in novel and innovative ways as long as it does no apparent harm to patients and FDA has no authority to stop them. I think this accounts for why FDA has a record of coming down on drug and cosmetic manufacturers with claims about what stem cells can achieve in contrast to cell therapy manufacturers who make a product available (with little or no written claims) to physicians who apply them for particular conditions.
Hi Michael,
I see your point and that could be a contributing factor. On the other hand, the FDA is fully empowered to regulate HCTP products, the devices used to make the products, and the procedures for administration. All these apply to the interventions sold by the clinics putting them squarely in the realm of FDA authority.
Paul
Again, FDA can regulate them as products IF claims are made. US companies use very crafted messages that suggest but don’t actually make claims; phrases such as “quality of life for our patients can be improved through stem cell therapy” [note uses can be improved, not will be improved], “We help your body restore itself” [help the body, not do it for the body], “According to research, stem cells have self-renewal qualities which aid in the reproduction of cartilage and bone tissue cells, the restoration of joint function, and the reduction of pain. This mean that stem cell transplants could be used to treat some of the most common orthopedic symptoms.” [have self-renewal qualities, but no claims what those are or how extensive they are], “Our technology has led us to breakthroughs that are changing medicine and improving life globally. As one of the few companies licensed and approved for clinical grade manufacturing and trial applications” [no specific claims beyond “breakthroughs that are changing medicine” and acknowledgement they are working in the clinical space; by the way, I am not aware of any reg agency that “licenses and approves clinical grade manufacturing”; they inspect and allow it to go on if the proper controls are in place to assure safety of patients]
For devices, if you look at firms like Cytori, their essentially liposuction device has not demonstrated any product it produces has a legitimate medical use worthy of regulatory approvals (after numerous clinical trial disappointments and failures). Their machine is approved in a handful of Asian Pacific countries but has no approvals for the harvested stem cells (at least that I am aware of).
Stem cell firms navigate around restrictions that FDA could apply IF they made claims. Clearly every firm keeps their lawyers close at hand before they put out any advertisements, press releases, etc.
According to the following page, the FDA’s regulatory mandate is far broader than this:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
If your reasoning were correct, biotechnology companies could forgo years of clinical trials and billions of dollars in costs and bring any drugs to market as long as they did not publicly advertise them. I believe this is false.