Is RevivHair Max Serum a cosmetic or a drug?

RevivHair Max Hair Stimulating Serum is a cosmetic. As a cosmetics company, we are legally bound by U.S. FDA rules and regulations. And the FDA's definition of a cosmetic: a product that is "for cleansing, beautifying, promoting attractiveness, or altering the appearance" and does not "affect the structure or any function of the body" which would make the product a "drug."

When developing products we often have to walk a fine line when it comes to formulating for efficacy and marketing claims. We cannot say that, for instance, a product "will grow hair." We have to be very specific about terminology. In fact, in general we don't use any specific claims for a particular product. Any claim verbiage we use is strictly related to the individual raw ingredients we utilize, and we use only major manufacturer data -- who are also under U.S. FDA regulations about what they can claim and what they cannot. Our manufacturer claim data is legitimate, bonafide, and accurate (and googleable).

So while we of course cannot say that RevivHair will "grow hair," we can say it may very well help provide the optimal environment for strong, healthy, thick looking hair. That may sound like marketing gobbledygook, but it's the law.

But what about "cosmeceuticals?" Aren't they a "drug?" From our colleagues at The Chemist Corner:


One other classification of products is cosmeceuticals. The oft-controversial but significant contributor to our field, dermatologist Dr. Albert Kligman, coined the term cosmeceutical almost 30 years ago. He defined cosmeceuticals as topically applied products that do have a physiological effect on the skin. The industry was quick to respond because the potential regulation of cosmetics as drugs could cripple innovation due to time and cost. Kligman, however, intended to draw attention to the potential biological effects of all cosmetics that did not just merely camouflage or add color. In fact he said it was “scientifically silly to pretend that cosmetics did not do anything” and that cosmetics might actually be doing a lot of good.

The term cosmeceutical is not recognized as part of the Federal Food, Drug, and Cosmetic Act. But whether you agree or disagree, this term has become part of our consumer’s vernacular. The controversy and conversation the term has created remains, in my mind, one of Kligman’s great contributions to cosmetic science.

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RevivSerums.com Debuts Another Cosmetic Breakthrough: RevivScalp, First Product Of Its Type With Award-Winning Swiss AnaGain

SAN FRANCISCO, MARCH 19, 2015 /PRNewswire/ – RevivSerums.com, a trusted brand in hair & skin rejuvenation products, announces RevivScalp Rejuvenating Scalp Serum Masque.

RevivScalp™ is the first product of its kind to include award-winning AnaGain™ from Mibelle Biochemistry AG in Switzerland. AnaGain won Beyond Beauty Lab’s Advanced Ingredient Award at its annual global showcase for personal care ingredients last September.

Designed for men and women, RevivScalp addresses thinning hair, scalp itching and irritation. Anti-inflammatory and gently exfoliating, it also encourages blood circulation and a healthy supply of oxygen to the scalp. It adds volume and strength to hair, and helps fine, thin hair look and feel like full, thick hair.

A three-month clinical study showed that AnaGain increased the density of anagen hair by about 8% and reduced the density of telogen hair by 28%. The proportion of active follicles from 4 to 7.2 indicates a strong hair-regrowing effect.

"I've been using RevivScalp now for over two months, and I'm pleasantly surprised with the changes. My usual itchy, flaky scalp feels really healthy, and my fine, thin hair is definitely coming in thicker and stronger, and looks much healthier," said Gary Baumgartner, a tester for the new topical.

RevivScalp also incorporates other new landmark ingredients:

Anageline™ shows a significant inhibiting effect (-18%) on the activity of 5-alpha reductase II, an enzyme responsible for follicle miniaturization.

Fluidipure 8G™, according to its developer SEPPIC, helps combat scalp redness & oiliness, hair oiliness and dandruff. It also helps reduce 5a-reductase and fights scalp odor.

Bioenergizer PBG™, also from SEPPIC, has stimulating and sebum flow regulative properties.

Cressatine™ helps initiate hair regeneration via the Wnt pathway and keratinocyte differentiation.

5 Alpha Avocuta™ is shown to significantly inhibit 5-alpha reductase activity, and help prevent itching, redness and desquamation.

SymSitive™ 1609 works as an “anti-nerve hyper-activator” to calm over-reaction of hypersensitive skin, and help prevent stinging, burning and tingling.

Redensyl™, in-Cosmetics Silver Award winner, targets OCR hair follicle stem cells.

RevivSerums also announces that its best-selling, highly-rated Hair Stimulating Serum is now named RevivHair. RevivHair and RevivScalp contain complimentary ingredients to boost the efficacy of each product, and are meant to work together.

RevivScalp debuts today for only $39 for a limited time. Its release coincides with the 73rd American Academy of Dermatology #AAD15 conclave in San Francisco, hometown of RevivSerums.com. #RevivScalp is available at RevivSerums.com, which ships to most countries worldwide, and select retailers, salons and physician's offices.

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RevivSerums.com is a wholly owned component of Astonishing Developments Ltd. in San Francisco, a global leader in topical therapies for hair, scalp, lashes and skin.
Legal
RevivScalp and RevivHair are trademarks of Astonishing Developments Ltd. Other company and/or product names may be trade names, trademarks and/or registered trademarks of the respective owners with which they are associated. These statements have not been evaluated by the U.S. Food and Drug Administration. Products not intended to diagnose, treat, cure, or prevent any disease.

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Reference data for RevivHair Stimulating Serum and its primary ingredient, Redensyl

Trichogram photographs (from the double blind versus placebo clinical trial, grade 3 to 4 alopecia volunteers) display the results after only three months. The subject on the far-left (52 year old tester) had 28,200 visible new hairs (+ 47 hairs per cm2). Of course, at three months they are not "full-length" hairs, but obviously enough to show a visible, discernible difference, and as you can see the growth is evident on both the hairline and crown. A reminder that the average person has at least 100,000 or more hairs on the scalp, so it makes sense that this tester visibly shows a 28% increase in density in the photograph.

The 28,000 number is a maximum experienced by the testers in the study; the average was less. Perhaps the most striking effect was that hair fall decreased 17%, and we have many customers who have commented (and posted reviews) that they experienced real results within just a week or two of starting RevivHair Max Stimulating Serum, primarily by it noticeably helping with the appearance of existing shedding. While everyone is of course "bio-individual" you may very well find that you can expect this effect in just a few weeks of use.
The efficiency of Redensyl® was evaluated in the double-blind test versus a placebo. Twenty six male volunteers were selected by following specific inclusion criteria: between 18 to 70 years old, brown to dark hair, with a minimum density of hair of 150 hair/cm2 and 40 telogen hair/cm2, with clinically confirmed grade 3 to 4 alopecia. Volunteers applied the placebo or the product with 3% of Redensyl® on their whole scalp daily for 3 months.

A shaved area of 1.5cm2 was defined on each volunteer to allow the measurements on a window of 0.7cm2 at D0, D28 and D84. Phototrichograms were realized using a NIKON camera associated with Canfield® Epiflash System and a contact plate to press hair on the scalp. Analysis were run with Photoshop CS5 extended® and permitted to define if hair were in anagen, telogen or undetermined phase.

Results: A non significant placebo effect is observed (mechanical activation of micro-circulation), with almost no more evolution after 1 month. Redensyl® increases the percentage of hair in anagen phase by 9% compared to T0 after 3 months, and decreases the percentage of hair in the telogen phase by 17% compared to T0 after 3 months.

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Global news of our new RevivHair Stimulating Serum formulation with Redensyl

 

Reviv Serums is one of the first companies in the world to formulate a product with Redensyl® from Induchem, and this long-awaited product launch news has been picked up by almost 1000 different syndicated networks and online sites! It's been featured on the giant Reuters News sign in Times Square four different times already, and hit the wires on Reuters, DOW Marketplace, Yahoo, The Boston Globe, among many others. Here's just a sample list of the many, many articles:

 

 cbs8hd.com  wdam.com  kttu.com  wfsb.com  wxvt.com  tulsacw.com  weht.com  ksby.com  nebraska.tv  km3news.com 

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Addressing greying hair isn't just a vanity issue; it's a scalp and skin health issue too.

Asian man examining premature greying hair

Addressing greying hair isn't just a vanity issue; it's a scalp and skin health issue too.

Premature greying of the hair is a condition known as canities; the diminishing of pigment in hair producing a range of colors from normal to white that is perceived as gray.

It is a complex multi-factorial process mainly considered to be an interplay of nutritional, genetic and environmental factors. Nutritional deficiencies like vitamin B12 deficiency, severe iron deficiency, chronic protein loss, copper deficiency are often found associated with premature greying of hairs. Other factors that have been incriminated are low serum ferritin, and low serum calcium and vitamin D3 levels.

Smoking is another factor that is considered to be related to premature greying of hair. Smoking results in generation of huge amount of reactive oxygen species leading to increased oxidative stress culminating into damage to melanin producing cells, melanocytes. Prolonged exposure to ultraviolet rays is considered to initiate similar processes in hair follicles resulting in premature greying of hair.

It turns out that a key factor in hair color loss happens to be the buildup of hydrogen peroxide in the scalp and hair follicles. As we age, our bodies become less able to neutralize that hydrogen peroxide, which interferes with an enzyme that is responsible for producing the pigment in hair. The graying begins when the synthesis of melanin (the natural pigment that gives hair its color) is disrupted.

https://www.ncbi.nlm.nih.gov/pubmed/24695442
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2929555/

Another recent study in Nature Medicine suggests that sun damage may very well speed up the graying of hair. The study found that when UV exposure damaged skin, melanin-producing stem cells migrated upward to the skin to produce protective pigment (a tan) but abandoned their position in the hair follicle.

While there are many other factors that can contribute to graying hair (genetics, ethnicity, stress etc.), these studies suggest there are steps you can take to slow down or minimize graying hair:

The revolutionary ingredients, like Greyverse and Darkenyl, found in our RevivHair REV Stimulating Serum may help prevent hydrogen peroxide buildup and target tyrosinase to help prevent the loss of hair color and the appearance of darker hair, naturally without dyes or pigments. Another included ingredients (also mentioned in the study) may help: Methionine Sulfoxide Reductase.

Additionally, wearing a hat or applying a UV protection product for the hair (more specifically, the scalp) whenever you're outside, may help as well. Wearing a hat to shield UV damage is something we should be doing anyway!

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