How Does The Law Define Cosmetics?

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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)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

HOW DOES THE LAW DEFINE 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)].

“COSMECEUTICALS”

The FD&C Act does not recognize any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law.

LABELING

A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as “Active Ingredients,” followed by cosmetic ingredients, listed in order of predominance as “Inactive Ingredients.”
If the product label says “Ingredients” only, it contains nothing that is beneficial for your skin beyond simply moisturizing it.

IS IT PERMITTED TO LABEL COSMETICS “FDA APPROVED”?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA’s Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].

Vitamin C

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Vitamin C, also called ascorbic acid, is a popular natural ingredient used in skin care cosmetics. There are two mechanisms by which it can affect your skin.

Vitamin C is an essential component for collagen synthesis. Without adequate vitamin C, the collagen in your skin would be malformed and your skin and gums would not heal properly. This is obvious in patients who are clinically deficient of vitamin C, a condition called scurvy.

Vitamin C is a potent antioxidant. Like other antioxidants, it helps to prevent skin damage and wrinkles by soaking up harmful free radicals.

The problem is how to get the vitamin C into your skin. Your skin is designed to keep things out (on the whole, a good idea), but this makes getting medications and creams below the surface, where they exert their effects, rather difficult or simply impossible.

In order for vitamin C to penetrate the skin, it needs to be in an acidic environment, and it needs to be in a high concentration in the product. Unfortunately products that contain potentially effective concentrations of ascorbic acid would be very expensive.

In addition, topical vitamin C is highly degradable. When exposed to air it oxidizes and its free radical soaking capabilities are muted — it becomes an inert, yet nicely citrus fragranced cream.

It’s extremely unlikely with commercially available amounts of Vitamin C/ascorbic acid to have any measurable impact on your skin.

So, You’re Thinking About Botox?

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Yet, you’re not sure if it is safe to have a poison, and this one is a mighty strong one, injected in your face, whether it is a painful and bruising procedure or if a dropped eyebrow, funny smile and drooling are the norm. And certainly, you do not want to look “plastic”, flat with expressions that of a rail…as the cloned features you just saw a few days ago on the pages of a local social magazine!

Botox is a toxin that in some hands becomes a magic wand; in others it is a poison. It is produced by specific bacterium, accidentally discovered to smooth the wrinkles; in more than 2 decades it has become the most frequently used injectable in the world with amazingly high safety record.

Botulinum toxin does not work directly on a muscle; it simply prevents its stimulation by either blocking or weakening the impulse coming from the brain.

Historically botulinum toxin has been used for “frown lines”, forehead lines, “bunny lines” at the bridge of your nose, to flatten the “crow’s feet” and improve the upper lip “smoker lines” (drinking from a bottle or through a straw contributes greatly to these lines).

Under certain conditions you may benefit from particularly tiny doses injected into the cheek lines; only a small dose is necessary to make your eyes bigger and to elevate a tip of the nose or corners of the mouth.
A total face sculpting can be achieved with botulinum toxin using relatively small doses. Indeed, much smaller than so-called “recommended” doses.

Botox can be used in treatment of horizontal neck lines and vertical neck “bands” as well as the mid-chest wrinkles; it is used successfully in treatment of migraine and other headaches and in hyperhydrosis or excessive sweating. It may be very useful in numerous neurological disorders, gastroesophageal reflux and incontinence although many of these have not yet been approved by FDA.

It seems that every year brings more possibilities of using botulinum toxin in various medical conditions.

The concept of aesthetic botulinum toxin has changed around the world several years ago yet very few are ready to introduce it here since it would require a significant decrease in the dosage.

What is this “new” concept?

The point is to re-inject the treated areas as soon as the muscle strength is increasing. Consequently, if a wrinkled skin remains relaxed for several months (usually no more than 3-4 cycles) it is enough time for the skin to “repair” itself and the underlying wrinkles are fully corrected. Then, only a minimal dose may be needed to maintain the effect and chances are the effect will last longer.

This can be achieved by either using a “recommended” industrial doses to paralyze your face or by having much smaller doses that will allow you to maintain your expressions and look natural.

Ask questions, educate yourself then ask…more questions. No, there is most likely no need for 6 injection sites in your forehead…and no, it is not always necessary to inject the muscle between your eyebrows. And yes, it is a good idea to start with a smaller dose. You can always add more…

Above all, ask your doctor and remember the number of units injected as well as the concentration of the Botox.

Dysport is an alternative to Botox. It is a similar toxin produced by the same bacteria and used for decades outside of the US has been recently approved by FDA.

It’s price? Pretty much the same…

Effect? Similar…

The difference? You may expect to see results much sooner and these may last longer.

However, Dysport is somewhat weaker than Botox therefore requires more units to be injected.

The choice is clearly yours.

And remember: Less is more…

Retinol vs. Retin-a

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Most wrinkle creams simply hydrate skin, plumping them out and making them look temporarily better. So don’t buy into the hype.

There is one product that has a solid history and reputation for reversing fine lines, however, and that is Tretinoin (Retin A)

Tretinoin creams or drops penetrate the skin and increase skin cell turnover.

Studies have shown them to be effective at treating acne, reducing fine lines and wrinkles, and reversing the effects of photoaging, or sun damage. The ultimate results are related to the markedly increased collagen production.

Although our own internal Vitamin A (retinol) does stimulate collagen production but when applied externally on your skin it’s absorption is minimal and further conversion to collagen-stimulating tretinoin is nearly undetectable.

 

So, You Thought About A Filler?

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Dermal fillers…another tool for beauty enhancement that could turn into anti-aesthetic nightmare. Yes, the same social magazines, TV and commercials are filled with monstrosities created in the name of anti-aging medicine…over-inflated lips, protruding cheeks, lumps and lines that blossom when you smile…when you talk…sometimes when you move.

Amazingly, I have watched a promotional video made by one of the manufacturer of dermal fillers. The models had some of the above features…a sad reminder that aesthetics are attributes of art rather than a mechanically simple ability to empty syringe into ones face. And yes, the word aesthetic means art.

Regardless of your experience, you are anxious about the pain, bleeding, bruising, bumps and unnatural look. And, regardless of your experience, you will be amazed how minimal the discomfort could be….not more than the injection of Botox. And this is a norm at VISAGE MedArt….and I would challenged anyone who will tell you otherwise…you can simply ask our patients.

The two most important questions are…which filler is best for me and where to place it.

And here is the first problem. The most frequently injected area, the naso-labial folds, folds that run from the nose down toward the corners of mouth, are injected mostly without a significant aesthetic effect. Yes, you can have your folds less deep…even completely flat but, the chances are, you still look tired and aged…you still have a signs of aging although the filler is already in….injected supposedly to reverse the signs of time. And you’ve paid for it?

There are very few but key areas of the face that will make a dramatic improvements instantly and there are places, injected too frequently, where the effect is mediocre. Frequently, in my opinion, placing a filler in There are certain areas where, in my opinion, injecting filler is a waste of money.

You may ask why it happens? The answer is quite simple. Injection, as a physical act, requires rather basic skills. The anatomy of the face is pretty consistent and learning it does not require extraordinary mental skills. Yet, what is required above all, is an artistic understanding of spatial relationships and art form, ability to invision the outcome before the needle enters your skin. And this, only this, makes filler injection a difficult task, achievable only by those who have artistic inclinations. Since a good plastic surgeon, in order to be good, must be artistically inclined, I would find much more comfort in their abilities than any other medical specialty.

There are very few non-permanent fillers approved and available in the US. What matters mostly for any patient is the duration of filler’s effect and its price.

  • First, the longevity of the product that is claimed by the manufacturer does not reflect any specific case. These are for orientation purposes only and duration varies significantly; this must be discussed with any patient interested in any filler in order to avoid disappointments. As always, take the manufacturer claims to be the best case scenario and not the norm.
  • Second, some fillers are better than others for a specific area; eg. you don’t want some products to be injected into your lips or near your eyes. And since only very few products are available, you can learn what’s best quite easily.
  • Third, the price of fillers.. The prices vary from region to region, from office to office. A medspa around the corner may have much lower prices; at this does not necessarily mean that the injector is less “qualified” or less skillful. What it means is that the abundance of aesthetic services have created an atmosphere of “flea market” mentality, far from the medical artistry required for the optimal results.

It would be to your advantage to learn which are the most cost efficient fillers available.

This can be easily determined by considering the average duration of the effect and the size of syringe.

There is a substantial volume difference between the products ranging from 0.75 cc to 1.5 cc per syringe. It just happens that the largest syringe by volume contains a filler that last the longest. And this filler requires much more conscious and precise placement that the others since misplaced product may violate the rules of aesthetics giving very undesirable effects that may last for a very long time.

How many syringes you may need? Shoot for less rather than more. You can always add more later.

I am not good in estimating the amount one may need if, in my assessment, one syringe is not enough. Few months back one of my patients asked me this question. I responded that he may get away with two. And just few days ago, over 3 months later, I injected the seventh syringe! Yes, the patient looks absolutely great and natural even during the most extreme facial expressions. But it proves again and again that a slow approach, a small volume at the time, pays off and prevents mishaps. There is no place for rush or cavalier approach. It’s your doctor’s choice. But it is your face.