Hi,
I have two queries:

I recently received a sample of folligen cream, and will probably be ordering some for scalp use in the future. However, even tiny bits applies to the lash and brow area cause sufficient irritation that I cannot use it there. There seems to be a minty/menthol component to Folligen, and I suspect that this is what's causing the irritation around my eyes. Have you considered creating a Folligen specifically formulated for brows and lashes?

Secondly, have you considered making a DMAE cream? I purchsed one from another source, really like the firming effect that it has, but it's so loaded with fragrance that I'm reluctant to use it. One thing that I especially appreciate about Skin Bio products is their minimalist formulation.

Thanks-

You might try CP Serum for your brows and lashes.

We are formulating a new basic Folligen and if this works well, we may hake a eyebrow product.

We had a lot of DMAE but UPS managed to destroy it, and we have ordered more. But we will first make a solution.

Would it be possible to make new folligen and SRCP formulations that are paraben free?
I know there are debates about it, so if there is a way to avoid using it (maybe just increase mixed tocopherols?), would that be possible?

Parabens.........

Preservatives

The preservative that we use are all on the FDA's GRAS (Generally Recognized As Safe) list. They have a long history of safe use. Our creams kill most dangerous pathogenic bacteria such as Staphylococcus aureus, Streptococcus, and pseudomonas.


Parabens.........

Parabens are not linked to cancer

Parabens are molecules from plants, such as blueberries and soybeans, that are used as preservatives in foods and cosmetics. Parabens have some estrogenic activity and there have been concerns as to their safety with respect to cancer.

The Scientific Committee on Consumer Products for the European Union wrote an Extended opinion on: the Safety Evaluation of Parabens covering in addition isopropyl paraben. <http://europa.eu.int/comm/health/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf> Adopted by written procedure on 28 January 2005. In summary, they said there was no link between parabens and breast cancer and criticized the data used in previous studies.

While parabens appear to be safe, this may not be true for other estrogenic materials such as sunscreen chemical oils and the thousands of alien chemicals that the cosmetic industry adds to products.

So why the difference? Normal foods contain most of the carcinogens to which our bodies are exposed. But our metabolic systems have long been adapting to these molecules and have methods to detoxify them. So parabens, being nothing new to the body, can be detoxified by our bodies. In contrast, estrogenic chemicals such as sunscreen chemicals, PCBs, and DDT are alien chemicals to our body. There is nothing in our genetic heritage to tell the body how to detoxify and remove them molecules. This is the danger of alien, unnatural chemicals.

So the parabens are absolutely needed to maintain the antimicrobal properties?

The FDA requires that cosmetics resist bacterial growth. Parabens are the safest anti-microbial molecules.

All cosmetics and personal care products are marketed in the U.S. without FDA pre-approval for efficacy or safety, including the preservatives used in cosmetics because the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not authorize FDA to approve cosmetic ingredients. The FDA only regulates drugs, some color additives and hair dyes, and sunscreen ingredients. The cosmetic industry is self-regulated, and The Cosmetic Ingredient Review (CIR) is its industry sponsored scientific body.

“The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature. FDA participates in the CIR in a non-voting capacity.” Source: “Parabens,” CFSAN/Office of Cosmetics and Colors, March 20, 2006

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I wouldn’t worry about the use of parabens in cosmetics, including the Skin Biology products, at this time for the following five reasons:

(1) Until new data indicate otherwise, the daily cumulative paraben exposure from cosmetics (and food) is relatively low and any currently linked health risks to paraben use in cosmetics range from low, unknown, or unproven.

Generally, a dose and its relationship to a species dependent biomarker has to be established or observed consistently to make a direct link between the metabolism and elimination of any chemicals (naturally occurring or synthetic) causing systemic toxicity or carcinogenicity in humans, especially through topical absorption.

“… in 1984 and [CIR] concluded they were safe for use in cosmetic products at levels up to 25%. Typically parabens are used at levels ranging from 0.01 to 0.3%.”

“In September 2005, the CIR decided to re-open the safety assessment for parabens to request exposure estimates and a risk assessment for cosmetic uses. In December 2005, after considering the margins of safety for exposure to women and infants, the Panel determined that there was no need to change its original conclusion that parabens are safe as used in cosmetics.” Source: “Parabens,” CFSAN/Office of Cosmetics and Colors, March 20, 2006

“Although parabens can act similarly to estrogen, they have been shown to have much less estrogenic activity than the body’s naturally occurring estrogen. For example, a 1998 study (Routledge et al., in Toxicology and Applied Pharmacology) found that the most potent paraben tested in the study, butylparaben, showed from 10,000- to 100,000-fold less activity than naturally occurring estradiol (a form of estrogen). Further, parabens are used at very low levels in cosmetics.” Source: “Parabens,” CFSAN/Office of Cosmetics and Colors, March 20, 2006

(2) The causal link that Parabens caused the proliferation of MCF-7 breast cancer cells had not been established.

Though the estrogenic-like activity associated with parabens in cosmetics is comparatively weaker than the body’s naturally occurring estrogen, the estrogenic potential of parabens associated with breast cancer cells warrants further endocrine toxicity study. However, neither paraben use in cosmetics in low-dose levels or for long-term has been identified to either cause estrogenic effects on breast cells or significantly increase the growth rates of MCF-7 breast cancer cell line like coffee, dong quqi, ginseng, and commercial combination soy, red clover, and herbal products can. Source: “Problems With Preservatives?” http://www.cosmeticscop.com/learn/article.asp?PAGETYPE=ART&REFER=SKIN&ID=152

Citing the study published in the Journal of Applied Toxicology, Vol.24, Issue 1, Cosmeticscop.com suggests that “Parabens present in tumors may not be the causative factor but rather a result of parabens when cancer cells are present. “ Source: http://cosmeticscop.com/learn/dictionary.asp?TYPE=SEARCH&ID=P

(3) The meaning and significance of the presence of parabens in human tissue hasn’t been determined. Some critical reviews of parabens causing cancer or promoting estrogenic activity associated with certain forms of breast cancer (or the Darbre study published in 2004) summarized below:

Estrogen from many sources can bind to receptor sites either strongly or weakly and can generate either a beneficial or an abnormal estrogen response. And since parabens from cosmetics and personal products are not the only sources for estrogen action, but biologically-produced estrogen and other wholefoods, such as, soy, coffee, ginseng, dong quai, red clover, and herbal products can also cause greater estrogenic effects, scientists and the FDA haven’t determined the exact source or cause of the estrogenic activity, and whether estrogenic activity from these sources poses health risk for humans. Other expert opinions:

“The possible estrogenic hazard of parabens on the basis of the available studies is equivocal, and fails to consider the metabolism and elimination rates of parabens, which are dose, route, and species dependent.” Source: “Safety assessment of esters of p-hydroxybenzoic acid (parabens),” Soni MG, Carabin IG, Burdock GA, Burdock Group, Food Chem Toxicol., 2005 Jul;43(7):985-1015

“Based on these comparisons using worst-case assumptions pertaining to total daily exposures to parabens and dose/potency comparisons with both human and animal no-observed-effect levels (NOELs) and lowest-observed-effect levels (LOELs) for estrogen or DES, it is biologically implausible that parabens could increase the risk of any estrogen-mediated endpoint, including effects on the male reproductive tract or breast cancer.” Source: “A review of the endocrine activity of parabens and implications for potential risks to human health,”Golden R, Gandy J, Vollmer G., ToxLogic LC, Potomac, Maryland 20854, USA. RGolden124@aol.com, Crit Rev Toxicol. 2005 Jun;35(5):435-58

“… the study did not show that parabens cause cancer, or that they are harmful in any way, and the study did not look at possible paraben levels in normal tissue.” Source: “Parabens,” CFSAN/Office of Cosmetics and Colors, March 20, 2006”

Cosmeticscop.com also cites papers from various sources, such as the Journal of Applied Toxicology and the Journal of the National Cancer Institute, sharing the view that the information about parabens to date is vague and require more study. And the consensus of these reviews is that “the presence of parabens in human breast tumors doesn’t mean they caused the tumors in the first place.” Source: “Problems With Preservatives?” http://www.cosmeticscop.com/learn/article.asp?PAGETYPE=ART&REFER=SKIN&ID=152

Scientists also found that there is no link between underarm deodorant and breast cancer risk. Source: “Problems With Preservatives?” http://www.cosmeticscop.com/learn/article.asp?PAGETYPE=ART&REFER=SKIN&ID=152

(4) Parabens used as cosmetic preservatives resist microbial growth effectively and cause low incidence of allergic reactions.

I personally would not want to buy any OTC personal care products without preservatives or antimicrobials that ensure the efficacy or integrity of the ingredients or formulations. If I want evidence-based natural skin care or products with only "clean" ingredients, I'll make them myself. I don't need to buy bottled "safe natural" products when I can just as well make them in small batches.

According to Zoe Diana Draelos, M.D, “Probably the best skin care and cosmetic preservatives are the parabens… their ability to eliminate microbial growth from creams and lotions in an affordable, safe manner… the incidence of true allergic reactions to parabens is low.” Source: “What is the least problematic preservative?” http://www.dermatologytimes.com/dermatologytimes/articl...etail.jsp?id=322242

(5) Cosmeticscop.com suggests that avoiding 90% of food and consumer products with parabens or finding like substitutions will be challenging.

Moreover, most “natural” product lines make exaggerated or unsubstantiated claims about the benefits and harm of skincare products and ingredients and often use parabens as preservatives (and other synthetic chemicals) with or without knowledge nevertheless. They may also market parabens as “natural” or “food-grade” like substances formed from an acid found in raspberries and blackberries.

"Natural or organic" skin care product lines have not proven to be any safer, more effective, or of a higher quality in my experience. I do use antioxidant oils from JASON and Home Health, however.

"Natural" doesn't mean better or safer, either, when many laboratory roden carcinogens, mutagens, toxins, and "poisons" occur naturally in our foods (pineapple, apple, coffee, potato/swt. potato, lima bean, carrot, nuts, cherry tomato, bread/rolls, broccoli spear, herbs, spices, roasted meats/turkey, r/w wines, teas, and etc.) and in mother nature. Plants, for examples, have a myriad of poisons and carcinogens, both natural and synthetic, to repel predators and bugs and resist infections but humans eating a mostly plant-based diet has not proven harmful but beneficial. In fact, independent epidemiological evidence (as well as laboratory animal studies) just on data on diet alone suggests a high intake of fruits and vegetables (with known naturally-occurring and synthetic carcinogens and toxins present) daily and associated low coloric diet do not cause harm but protect against most prematuring aging chronic diseases and reduce and can reverse the risks for and coronary heart disease and many hormone-dependent cancers of the breast, prostate, ovaries, and colon.

It would seem that all chemicals, whether natural or synthetic, can be toxic at high doses but are perfectly safe when consumed in low doses, and our presumption or bias that natural chemicals are not hazardous but synthetic ones are has no scientific support.

A SIDE NOTE:

I also find it somewhat contradictory about people who advocated against the use of preservatives or antimicrobials in cosmetics due to their unsubstantiated harm and weak estrogenic activity yet had little concerns about or were very free and willing about experimenting and using potent topical actives or topical combination therapies on the face (preservatives can interact chemically or enhance penetration other ingredients/toxins/carcinogens), supported the use of DHEA (supplements or injection) and steroid/hormone therapies, or other exogenous agents and endocrine disruptors that directly affect the endocrine system for “anti-aging” purposes or for treatment of adrenal/chronic fatigue. Similarly, I cannot get a friend of mine to quit smoking because he justifies and rationalizes that he smokes natural and organic tobacco products, takes supplements, and eats organic (and exercises moderately).

This message has been edited. Last edited by: JW,