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Category: General and Misc.

general and miscellaneous posts

How many cosmeceuticals can fit on the head of a pin?

How many cosmeceuticals can fit on the head of a pin?

    How many cosmeceuticals can fit on the head of a pin?

None, according to the FDA, because there is no such thing.  In FDA-land, there are only regular cosmetics which are essentially un-FDA regulated, and cosmetics which are drugs and regulated as drugs, meaning full-on FDA new drug approval applications.

My guess is that the term “cosmeceuticals” was created from an analogy to nutraceuticals which are dietary supplements which have some structure/function type of medical application or value. Nutraceuticals is a thing because DSHEA allows structure/function claims. Cosmeceuticals don’t exist (from a regulatory point of view) because there are no permissible structure/function claims for cosmetics. (More about this later.) So in a way, a cosmeceutical manufacturer is someone who is manufacturing an illegal product, but hasn’t been stopped by the FDA yet. That is the theory anyway.

In truth, I’ve always had some reluctance to dive into the FDA cosmetic legal arena because of what I thought was a regulatory disconnect between the law and FDA enforcement actions. But that has changed in the last year or two. Now the FDA is more aggressive in going after manufacturers/promoters of cosmetics who make drug/disease/structure function claims. In the last eighteen months or so, it has sent at least a half dozen warning letters to cosmetics companies making drug/disease/prevention/structure function claims. Warning letters are sent to specific companies, but they also are one of the FDA’s main tools for ensuring compliance with the law amongst the industry as a whole.

Two definitions

What are cosmetics?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].

Stuff like skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product would all be considered cosmetics.

The problem area to me is the “altering appearance” thing. I don’t think the FDA gives it a very broad meaning, as some examples from warning letters will show.

What’s a Drug?

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

A product which makes a structure/function claim is a drug, unless it is a dietary supplement (i.e. ingested as a dietary aid) in which case a structure/function claim is permissible because of an exception to the drug definition contained in DSHEA (the 1994 dietary supplement act).

The important take away is that there is no parallel exception for cosmetics (or medical devices). Therefore, based on the functional definition of a drug, if you are a manufacturer of a cosmetic and make a disease/treatment/prevention of disease, or a structure/function claim, under FDA law, you’ve got a cosmetic which is also regulated as a drug. If you don’t have an NDA, you are manufacturing an adulterated, misbranded drug which you are illegally introducing into interstate commerce (or what I call the FDA trifecta, which by the way carries civil and criminal penalties).

What kinds of claims gets cosmetics manufacturers in trouble?

Here are a few claims culled from some warning letters: “removes wrinkles instantly, Ideal for treating, sun spots, age spots, acne scarring, hyperpigmentation, supports the synthesis of new skin fibers, soothes and reduces redness and irritation, strengthen the skin’s ability to repair and protect itself.”

You can’t circumvent the law by attaching the claim to an ingredient rather than the whole product. For example the FDA has put the kybosh on claims that an ingredient “works in a similar way to Botox, increases cell communication and gene activation for the skin healing, thus it plays a fundamental role in the reconstruction of the skin tissue, is very high in lignans that support cell communication.”   So cell communication language seems problematical to the FDA. The FDA even took offense with a claim that an ingredient “helps increase skin hydration by inhibiting hyalurondase.”

Want to increase your odds of getting an FDA warning/cease and desist letter? Use “stem cells” in your product name or advertisements, and then talk about their healing and regenerative powers. The FDA is coming down very hard on stem cell clinics because of false advertising and drug claims, and it has recently issued several stem cell guidance documents, the gist of which is that stem cells are considered drugs.  So to the FDA, using “stem cells” in a name or advertisement for a cosmetic is like putting a sign on your door, web site and forehead that you are manufacturing an unapproved new drug which is misbranded and adulterated.

What about Docs who make disease/prevention/structure/function claims for cosmetics?

The good news: The FDA doesn’t normally involve itself with practicing physicians. So unless a doc is selling cosmetics over the internet, the FDA is unlikely to take issue with the promotion.

The bad news:  In the last few years, the state professional boards have given greater scrutiny to advertising by health care professionals for false or unsubstantiated product claims. Basically, whatever a manufacturer couldn’t or shouldn’t say under federal FDA law, usually can’t or shoudn’t be said by a health care provider under state board law. There might be exceptions and extenuating circumstances, but you shouldn’t get into to trouble by following the federal law.

So a guy jumps off a hundred story building. As he’s passing the 50th floor, he’s asked how he’s doing. “So far so good.”

Be careful!

Rick Jaffe


Saturday Night Gala for Brain Tune-ups for TBI Vets

Saturday Night Gala for Brain Tune-ups for TBI Vets

This Saturday night, I’m going to the Brain Wellness Gala at the Army/Navy Club in DC. The organization raises money for funding veterans with TBI (traumatic brain injury) to get treatment with an effective but completely non-invasive treatment involving micro current stimulation. It’s a form of Neurofeedback.

Here is info about the event.

Neurofeedback for therapeutic or lifestyle purposes isn’t new. But these folks have are using the technique on TBI’ed vets with some dramatic results. Sounds a little out there maybe, but, I actually have experience with the technique.

One of the best parts of my job is seeing all the cutting edge therapies and new health related technologies. Every case I work on I learn something new, and every health conference I go to I pick up something to incorporate into my health/wellness/fitness regime.

A dozen years ago, I had a case in Maryland involving therapeutic brain biofeedback or Neurofeedback. The practitioner was a highly regarded neuro feedback specialist. The case was straightforward. The practitioner had a PhD in psychology, but she was licensed as a clinical social worker. The Maryland Medical Board thought that Neurofeedback should only be done by a medical doctor, and certainly not by a social worker even one with the highest level of state social work credentials and a PhD in psychology. After enlisting the support of some heavy duty professional organizations, I got the medical board to drop the case. Later, the psychology board tried the same thing, and fortunately, we achieved the same result.

When I flew up for the initial interview for the practitioner with the board, I asked if I could try her treatment to see what it could do for me. Like I said, I’m into this stuff. She said no. She was afraid that it might interfere with my representation of her at the interview.

Several years later, when I was back in DC on another case, I asked again. This time she agreed. The first thing that happened was that she did a brain map of my electrical wave activity. When she looked at my brain map, she was shocked. She told me that my brain waves were all jumbled up. (Maybe she used a more technical term). She couldn’t believe the high level of functioning I had achieved, and she surmised that it had to take more energy for me to focus and stay on task than most other people. Something about all the noise and cacophony inside my head.

Next came the treatment. She hooked up some electrodes to my head, based on the results of the brain mapping. I didn’t feel anything as it was just micro currents. The treatment only lasted five minutes, so she told me. I couldn’t tell because I fell asleep. But maybe I wasn’t completely asleep. I felt my body, but it felt much lighter. After I woke up and the treatment ended, I felt refreshed. I don’t ever recall having as restful or peaceful sleep or whatever state I was in.

I thanked her and went on to my next appointment which was lunch with the Executive Director of a prominent health advocacy group. I’ve known her for some time and during the course of the lunch she commented that I seemed different, more animated and had better energy. I reflected on that, and in fact I did feel an unusual sense of calm, focus, and a level of positiveness, that a crotchety guy like me doesn’t get to very often.

The clarity and well-being lasted for days. Eventually, it wore off and I returned to my regular self, for some better but mostly worse.

Over the next couple years I didn’t have occasion to get back to the DC area, but I wanted to get back to that place, so I tried a few other brain biofeedback practitioners in Texas. They all used different techniques and devices. Your eyes tracked or try to control a rocket ship or race car. None of the other stuff got me back to my happy space. Some actually gave me severe and persistent headaches.

Last year I got back to DC area and had another couple treatments. It was great. The only other time I felt almost as good, brain and mood wise was when I was following a strict Paleo diet and became mildly ketogenic, but that was hard work and ultimately I couldn’t sustain the strict Paleo diet, and I lost most of the benefit. I’m hoping one of these days she can sell a portable unit so I can permanently reside in my happy place.

But back to the TBI vets. The practitioner has results from a study she did on the TBI vets, and they seem dramatic if not amazing. She’s continuing to treat TBI vets, but on a very small scale. I hope she and her team can take it to the next level. It’s been slower progress than she and her support group, had hoped. But maybe someone big will step forward and make it happen.

If you’re in the DC, come to the Gala this Saturday night November 11th. It should be fun and rewarding to hear some of the stories and meet some of the vets being helped by this treatment.

Info again about the Gala:

And if you’ve got jumbled brain waves and/or too much internal chatter, have Mary Lee Esty, PhD quiet things down and tell her Galileo’s Lawyer sent you.

See you Saturday night!

Rick Jaffe, Esq.

Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

CAM (Complementary and alternative medicine, now more commonly known as integrative medine) has always been polarizing in the medical community, and has consistently come under attack by conventional medicine advocates. In the time since I became active, it was the quackbusters, then the sceptics who evolved into the bloggers who attack all things CAM. Heretofore, they have have had a relatively small impact on the CAM community.

However, there might be a new threat developing which could have a much more serious impact on the CAM community.

I’ve only heard about a few specific cases, so it’s far too early to say it’s a trend, plan or a concerted effort. Here is what I’ve heard:

Amazon has recently stopped marketing a homeopathic line because of the products’ claims, which, according to Amazon, make them unapproved new drugs and hence illegal to market on Amazon. This may or may not have something to do with the FDA draft guidance document on homeopathic products published in late 2017. To my way of thinking, the draft states that essentially all homeopathic products are illegal new drugs, but that the FDA would only actively pursue those products which posed a substantial risk to consumers based on its published criteria. (Depending on who you ask, this is either a new poistion by the FDA, or the same position which the FDA always had on homeopathic remedies.)

Here is the draft guidance document:

The company is contesting Amazon’s determination. We’ll have to see how this shakes out.


Periodically, Google updates its search algorithms. It’s most recent update was on August 1, 2018. As part of the update, it does a medic update which among other things updates the algoithms for searches for health problems and clinics offering treatment for medical conditions.

Here is an article published a week after the August, 1st update, describing the update process. The article contains comments of some folks who appeared to be initially adversely affected.

There are at least 3 CAM clinics whose organic searches have dropped precipitiously, and heretofore successful adwords have stopped producing eyeballs.

Is this an intentional effort to stiffle CAM therapies, or is it just an unintended consequence from a global medical update?

It’s to early to tell. There are not enough data points and there’s no smoking gun (yet). But it’s worth keeping an eye on the situation and see how many CAM places and products are adversely impacted.

Is the Amazon thing connected to the Google thing? Again, way too early to tell. But again, it’s worth keeping an eye on.

Rick Jaffe, Esq.