The Food and Drug Administration & Cosmetics

I’m speaking at The Divine Female, an event from yogitoes and The Yoga Beauty Bar for conscious beauty and breast cancer awareness, on Saturday at 11:30 a.m. about deciphering beauty ingredients.  I was talking to my mom about it, and she espoused a view held by many – that the Food & Drug Administration (FDA) makes sure the beauty products we use are safe.

But that assumption is false.  In fact, despite the fact that most of us believe the FDA looks out for  us, when it comes to cosmetics, it really doesn’t. So I thought I would discuss a bit of background about the FDA.

The FDA is responsible for over-the-counter and prescription drugs and medical devices, biologics, food (except for meat, poultry, egg products, and the labeling of alcoholic beverages and tobacco) and food additives, radiological products, and cosmetics.  How the FDA oversees personal care products is the most relevant generally to this blog.

The FDA’s authority over cosmetics is relatively limited.  As explained on the FDA’s website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices.”  FDA does not approve cosmetics ingredients before they are placed on the market, with the exception of certain color additives and a few substances are banned from cosmetics.  In fact, the FDA explains

“[i]n general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.”

The list of prohibited or restricted ingredients is amazingly short.  In comparison, the European Union list of prohibited or restricted chemicals is over 1,100 chemicals, although some of the chemicals would never be found in cosmetics.

Who determines whether a cosmetic is safe?  As explained on the FDA’s website, “[c]osmetic firms are responsible for substantiating the safety of their products and ingredients before marketing,” and not the FDA.  In other words, no independent agency determines whether a product is safe.  In fact, the FDA doesn’t even define the criteria.  While the regulations provide that each ingredient must be adequately substantiated for safety prior to marketing, the FDA doesn’t provide clear guidance as to the meaning of “adequately substantiated” or “safety” for cosmetics.  If cosmetic companies don’t adequately substance a cosmetic product’s safety before marketing it, they are required to include on the label the following statement:  “Warning – The safety of this product has not been determined.”  But if there are no definitions or guidance, how does a company even determine whether a product complies?  In fact, the Environmental Working Group (“EWG”) states that it reviewed more than 20,000 cosmetic product labels and did not find a single one with the statement.  I’ve never seen such a statement either.

Of course, this doesn’t mean that cosmetics are inherently unsafe.  But, at least one study concluded that approximately 89% of the ingredients routinely used in cosmetics have not been assessed by the FDA or the industry.  According to the EWG, 98% of all personal care products contain one or more ingredients never publicly assessed for safety.

Who does review cosmetics ingredients?  The companies manufacturing beauty products may privately conduct their own assessments.  The cosmetics industry also relies upon the Cosmetic Ingredient Review (“CIR”).  The CIR was created by the cosmetic industry trade group to police the industry.  The CIR is funded by the member companies of the Cosmetic, Toiletry and Fragrance Association and its recommendations regarding safety are just that, recommendations, not requirements, and can be ignored.  Also, the CIR’s focus is whether a cosmetic ingredient causes irritation or allergic reactions, not carcinogenicity or reproductive or developmental toxicity.  For an illuminating discussion of the CIR and the cosmetics industry, I highly recommend Stacy Malkan’s book, Not Just a Pretty Face: The Ugly Side of the Beauty Industry.

Not only does the FDA have no authority to approve cosmetics ingredients before products hit the market, the FDA is not authorized to require recalls of cosmetics.

The FDA is also responsible for food contact substances.  FDA’s regulation of food contact substances is also relevant to this blog (think BPA for example).  Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials.  If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997.  In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions.  Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS.  As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval.  In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information.  Sounds crazy, doesn’t it?  As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

What is “safe” for these regulations?  According to the implementing regulations, the term “safe” means “that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.  It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.  Safety may be determined by scientific procedures or by general recognition of safety.”

So how does this voluntary GRAS notification process work?  Let’s look at one potentially relevant example.  If you’ve used or are using formula, you probably know  some manufacturers supplement their infant formula with DHA and ARA.  But, some manufacturers use DHA and ARA extracted from laboratory-grown fermented algae and fungus and processed with hexane, known as DHASCO and ARASCO, although not identified as such on the list of ingredients.  DHASCO and ARASCO are structurally different from the DHA and ARA found in breast milk.  The manufacturer of DHASCO and ARASCO submitted a notice to the FDA stating that DHASCO and ARASCO added to infant formula are GRAS.  The FDA responded to the notice that it had no further questions.  DHASCO and ARASCO are currently marketed in infant formula.  But, the FDA and the manufacturer recognize that some infants have adverse reactions from consuming infant formula with DHASCO and ARASCO such as diarrhea, bloating, vomiting, jaundice, apnea, flatulence, and other gastrointestinal problems.  Nevertheless, the manufacturer maintains they are GRAS, so the manufacturer is free to market them.  And these infant formula products are not labeled to indicate the presence of DHASCO and ARASCO (as opposed to DHA and ARA), so you can’t tell when buying formula.

So that is a bit about the FDA. More information to come on deciphering beauty ingredients.


June Junk Claim #2: Aveeno Not So Natural

June Junk Claim #2 is Aveeno’s claim that “all of [its] products come from nature.”

Okay, so June Junk Claim #2 isn’t a specific product claim as discussed in the post for June Junk Claim #1. June Junk Claim #1 addressed Josie Maran Cosmetics’ false claim that the line’s Argan Mascara is petrochemical free.

But I wanted to talk about Aveeno. The Aveeno claims really bother me because people believe that the products are all natural.

So, Aveeno markets itself as using the science of Active Naturals, which are ingredients derived from nature and uniquely formulated by Aveeno to optimize skin’s health and beauty. Aveeno’s tag line is “that’s the beauty of nature + science.” And there is a little box on the website that states “all of our products come from nature.”

So the problem with the claim that its ingredients are “derived from nature” is that most of us picture flowers and herbs and similar items when we hear that the ingredients are derived from nature. We don’t picture petroleum derived ingredients. And there’s the rub. The claim that the products are “natural” or “derived from nature” has no legal or regulatory meaning. It means whatever the company wants, including long decayed organic matter (petroleum).

Aveeno has a reputation for being natural with a lot of parents and it isn’t deserved. If you buy the products because you like the smell or they work well, that’s great. But if you buy the products because you think that the ingredients are all natural, you might want to reconsider. Let’s look at the ingredients of Aveeno Baby Soothing Relief Moisture Cream, described as naturally soothing and hypoallergenic. The ingredients are:

Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Flour (Oat), Carbomer, Sodium Hydroxide, Ceteareth 6, Hydrolyzed Milk Protein, Hydrolyzed Oats, Hydrolyzed Soy Protein, PEG 25 Soy Sterol, Tetrasodium EDTA, Methylparaben, Citric Acid, Sodium Citrate, Benzalkonium Chloride Solution, Benzaldehyde, Butylene Glycol, Butylparaben, Ethylparaben, Ethyl Alcohol, Isobutylparaben, Phenoxyethanol, Propylparaben, Stearyl Alcohol

So, petrolatum and mineral oil are derived from petroleum. And while that is natural, it isn’t what you expect, is it?

Cetearyl alcohol can come from vegetable sources, or can be synthetically derived. Without more information, it is hard to say how natural it is.

Dimethicone belongs to a group of polymeric organosilicon compounds popuarly referred to as silicones.

Ceteareth 6 is a polyoxyethylene ester where the “6” indicates the average number of ethylene oxide residues in the polyethylene chain. To get ceteareth 6, ethylene oxide is used, which is derived from ethylene, which is derived from petroleum. Notably, because ethoxylation is used to derive ceteareth 6, it can be contaminated with the carcinogen 1,4 dioxane. 1,4 dioxane won’t appear on the ingredient list because it is a by product of manufacturing and is a contaminant, not an intentional ingredient.

Butylene glycol is derived from petroleum.

The production of phenoxyethanol involves ethylene oxide, which is derived from petroleum.

The various parabens in the product are synthetically produced. While some parabens are found in nature, all commerically used parabens are synthetically produced. And parabens are a group of compounds that many choose to avoid in products. One reason is that parabens have been detected in breast tumors, although no link between the topical use of paraben containing products and breast cancer has been found. Parabens do mimic estrogen, however. And, parabens can cause skin irritation and contact dermatitis in those with paraben allergies, which is at odds with the claim that the product is hypoallergenic.

Okay, so I think that advertising that pushes the natural basis for the Aveeno products is junk. And before you decide that it doesn’t really matter because the FDA makes sure that the products sold in the US are safe, think again. The FDA does not approve or evaluate cosmetic ingredients for safety before they are sold even thought most of us think that the FDA does undertake such a review.

If you want a more natural, soothing cream designed for baby, try Earth Mama Angel Baby’s Angel Baby Lotion.  (Yes, I’m an affiliate but this link is not an affiliate link.) Or  Weleda’s Calendula Baby Cream. Or erbaviva’s Baby Lotion.

Greenwashing: Beaute de Maman not so beautiful. Or particularly natural.

Polyetheylene plastic beads

I just don’t get the popularity of Beaute de Maman. Or why the line won an Editor’s Choice Award from Pregnancy Magazine in December of last year.

I really don’t get it.

The line is expensive.

But people like it because it is natural. I’ve found it in very upscale boutiques, with sales people touting its benefits.

But, the line is guilty of greenwashing.

 The product advertising states that

Beaute de Maman was conceived by Dr. Brown, an obstetrician whose ongoing mission is to provide safe and effective remedies for the common problems women face during pregnancy. Her fine line of skincare products has been extensively studied and evaluated, as well as allergy and obstetrician tested. The entire line contains only natural and herbal ingredients proven safe for the mother-to-be, the fetus and the breastfeeding baby. 

Those natural claims are repeated in the Connecticut Post and other press about Beaute De Maman.

And therein is my problem. The entire line is supposed to contain “only natural and herbal ingredients” but that isn’t true. Well, at least by my definition of natural.

Let’s take the first product – the facial scrub. The ingredients are:

Water (Purified), Glycerol Stearate, Ethylhexyl Palmitate, Butylene Glycol, Disodium Laureth Sulfocucinate, Sodium Cocoyl, Methyl Taurate, Polyethylene, PEG-100 stearate, Myristyl Myristate, Tridecyl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Phenoxyethanol, Acrylates/C10 30 Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Caprylyl Glycol, Triethanolamine, Iodopropynyl Butycarbamate

Okay, now realize that polyethylene is a plastic derived from petroleum. That means that this allegedly all natural and herbal facial scrub has tiny microbeads of plastic that pollute our oceans.

Guess what? Lots of the other ingredients are very, very far from “natural.” Take butylene glycol. It is produced by the petrochemical industry by steam cracking. In other words, saturated petroleum hydrocarbons are broken down into small hydrocarbons. Or take triethanolamine. Triethanolamine is produced by reacting ethylene oxide with ammonia. In turn, ethylene oxide comes from ethylene and oxygen, and ethylene is produced by the petrochemical industry by steam cracking.

Okay, how are those natural? Or herbal?

Last year, I tried to speak with Beaute de Maman about its products. I was specifically interested in the natural claim and also contaminants being present in ceretain ingredients. And I got a fairly snotty response from Laureen Schroeder, VP of Marketing, that kept emphasizing how the company has access to research not available to the rest of us.

First, and most importantly, she said that “we do not claim to be 100% natural – as we could not be effective.” Huh? Isn’t that at odds with the advertising?

She also said:

Our products have been researched using databases and reproduction toxicity reports available only to physicians. . . . According to Reprotox, which are physician only databases  . . .”

Okay Ms. Schroeder, hate to tell you, but Reprotox is a subscription service available to physicians and consumers. So, yes, I use the same databases that you do.

So, many of the ingredients in the facial scrub peaked my interest. Ethylhexyl palmitate, for example, is an irritant, and the CIR panel warns against using in products for use around the eyes or on the skin above a certain concentration. Butylene glycol has the same problem. Several ingredients are ethoxylated and can have the carcinogen 1,4 dioxane as a contaminant, including disodium laureth sulfocucinate and PEG-100 stearate. Phenoxyethanol is phenol reacted with ethylene oxide, which again is petroleum derived.

Now, Ms. Schroeder states that the “facial scrub has no dioxane or carcinogenic compounds. All ingredients used are pure with no contaminants. Again, Intertek, or the FDA of England, did extensive testing of all products and determined that repeated exposure to the ingredients will not cause skin irritation, even with prolonged or repeated use. The ingredients used are well known and present at typical concenetrations where they will not cause irritation or allergy and are deemed safe. There is no formaldehyde or carcinogenic ingredients.”

Okay, so it seems that perhaps the ethoxylated ingredients are vacuum stripped to eliminate the 1,4 dioxane. But when I asked about the detection level used (and we know that is important after the SIGG debacle), I didn’t get a response.

Obviously, formaldehyde isn’t an ingredient. But her statement that there is no formaldehyde doesn’t address whether there are formaldehyde donors. The thing is about formaldehyde donors is that they work by releasing small quantities of formaldehyde to make the environment – the product – less favorable to microorganisms. So how can she claim that there is no formaldehyde produced? I get it that the levels may be very small, but still. Formaldehyde, by the way, is a carcinogen. It also causes contact dermantitis. DMDM Hydantoin, for example, is a formaldehyde donor. Setting asside the whole formaldehyde issue, DMDM Hydantoin is also an irritant, a known human immune system toxicant, and is a human skin toxicant. It is restricted for use in cosmetics in Japan. It gets a 7 to 9 (depending on use) in Skin Deep’s Cosmetic Safety Database.

I’m also completely unconvinced by the reliance upon Reprotox. Beaute de Maman banks on its claims that the products are safe for pregnant women. (I have some questions about the specific claims because, well, they seem to cross into the product being a drug, not a cosmetic, but that is for the FDA. And the FTC.) But the thing is, we know that there have not be adequate toxicology reviews of most of the chemicals we use. Looking at the Reprotox entry for DMDM Hydantoin, for example, there is no information in Reprotox other than the CIR’s assessment from 1988. Hello? There has been more information since the industry-funded panel looked at it – and the CIR only considers irritant/allergen type responses for the most part, not developmental toxicity.

And, by the way, Beaute de Maman claims that “these products, cosmeceuticals, have medicinal propertiers in their ingredients ensuring the safety of both mother-to-be and baby.” That certainly sounds like they are super special, right? Just so you know, the FDA does not recognize any such category as “cosmeceutical”, as Beaute de Maman asserts that the products are. A product is a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the Federal Food, Drug and Cosmetic Act.

False Advertising & Blatant Greenwashing: Cargo’s PlantLove Botanical Lipstick at Sephora

cargo plantloveI am completely amazed at the blatant FALSE advertising for Cargo’s PlantLove Botanical Lipstick at the Sephora website. This lipstick has been recommended to me by several people, so I thought I’d check it out. But I haven’t done that, in part because I just haven’t been ready to sample new lipsticks. But also because I’ve been skeptical about Sephora’s Naturally Gorgeous Natural Seal, especially since it won the dubious distinction on one of the four biggest Enviro scams. 
In any event, I checked it out today after being prodded by a post on Sephora’s Natural Standard being a complete and utter sham. 

And I’m dumb founded by the completely false advertising. 

Truly, utterly, dumb founded. No wonder we all have such a hard time figuring out what we are doing when it comes to buying products. 

So, here are the claims for the product related to its “green credentials“:

This product is formulated WITHOUT:
– Parabens
– Synthetic Fragrance
– Synthetic Dye
– Petro-Chemicals
– Phthalates


This product has Sephora’s Natural Seal. Okay, sounds great, right? But then if you click on the ingredients, this is what you get:


All shades contain:
Ricinus Communis (Castor) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Mica, Candelilla Cera (Euphorbia Cerifera Wax), Cera Alba (Beeswax), Lanolin, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Phenoxyethanol, Tocopheryl Acetate, Jojoba Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Cymbidium Grandiflorum Flower Extract, Mangifera Indica (Mango) Seed Oil, Butyrospermum Parkii (Shea Butter), PEG-8, Tocopherol, Ascorbyl Palmitate, Citric Acid, Ascorbic Acid, BHT, Silica, Alumina, Isopropylparaben, Isobutylparaben, Butylparaben, Benzophenone-3, (+/-): CI 77891 (Titanium Dioxide), CI 15850 (Red 7 Lake), CI 77491/Ci 77492/CI 77499 (Iron Oxides), CI 15985 (Yellow 6 Lake), CI 75470 (Carmine). 

Notice the three ingredients in bold, common to all shades? Yes, those are parabens. So how stupid does Sephora and/or Cargo think we are? The lipsticks are advertised that they are formulated without parabens, yet all shades contain three parabens? 

And the company also claims that the lipsticks are manufactured without petrochemicals. Hello? Benzophenone-3 is derived from benzophenone, which is manufactured typically using benzene, a petrochemical. 

In other words, the claims for these botanical lipsticks are completely false. Shame of Sephora and Cargo.