US Government Regulation of Hand Sanitizer
The U.S. Environmental Protection Agency does not regulate hand sanitizers. While EPA regulates a wide range of antimicrobial products, it does not regulate products used directly on humans or animals.
Topical antimicrobial products are regulated by the Food and Drug Administration (FDA). FDA published a proposed rule on topical antimicrobial drug products for human use in the form of a ‘‘Tentative Final Monograph’’ in 1994. http://www.epa.gov/epp/pubs/guidance/fr73no94.pdf
All products that are marketed as over-the-counter (OTC) drugs must either receive pre-approval through the New Drug Application (NDA) process or they must comply with FDA’s OTC Monographs.*
A Cosmetics & Toiletries article “Comparatively Speaking: US FDA Categories of Hand Sanitizer Actives” gives an easy to follow explanation of the Monograph for the OTC drug, Hand Sanitizers:
“Hand sanitizers are considered drugs and regulated by the FDA under the 1994 Tentative Final Monograph (TFM).”
“The 1994 TFM classifies only two active ingredients as Category I (GRASE) for hand antiseptics: alcohol 60–95% and povidone iodine 5–10%. Since povidone iodine typically is not used in hand sanitizers, alcohol is identified as the only active ingredient the FDA currently recognizes as GRASE for hand sanitizers.”
“No natural product active ingredients, such as thyme, etc., currently are listed in the Monograph. Thus, natural antimicrobials are precluded from legal use in the United States, unless an approved New Drug Application (NDA) is obtained. At present, none have been granted.”
Last year the FDA announced that they had sent a number of warning letters and corresponding press releases about these warnings, directed at some companies that were selling illegal hand sanitizer.
Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections
“Examples of unproven claims found on product labels are
• kills over 99.9% of MRSA (methicillin-resistant Staphylococcus aureus)
• helps prevent skin infections caused by MRSA and other germs
• is effective against a broad spectrum of pathogens, including MRSA”
I asked the Clean Well Company on their Facebook page, whether they had any plans to submit an Application for their formula as a New Drug. My question was deleted and I was blocked.
UPDATE: Clean Well addressed the FDA WARNING: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm313996.htm
I personally find it ridiculous and short sighted and even dangerous that ingredients like triclosan and benzalkonium chloride, benzethonium chloride and parachlorometaxylenol (Category III ingredients) are allowed to be used as active ingredients in Hand Sanitizers by law, while essential oils are not…but that is the law.
“Since the monograph currently is in a tentative state, manufacturers are able to market hand sanitizers based on Category III ingredients.”
Seriously? Since 1994 there MUST be sufficient scientific data to remove triclosan and at LEAST move some essential oils to Category III! (Triclosan…Why It Should Be Banned)
THIS is yet another reason why I don’t think the FDA should have MORE control over the safety of cosmetics – look how far they’ve come with just ONE category of OTC drug in 18 years! NO WHERE!
But…that’s the law…so companies should either follow the law or work to get it changed.
From the FDA: Advice for Consumers – Don’t buy over-the-counter hand sanitizers or other products that claim to prevent infection from MRSA, E. coli, Salmonella, flu, or other bacteria or viruses. If you find products on the Internet that you believe make false or unproven claims, tell FDA by following the instructions at Reporting Unlawful Sales on Internet.
I reported the company Ava Anderson NonToxic because they have been selling “Hand Sanitizer” that does not follow the FDA Monograph…in fact…they promote that it contains no alcohol! Their salespeople have even pushed this product at nurses in hospitals and tried to convince them to use it instead of the FDA-approved alcohol hand sanitizer. Well when I read that…I wrote to the FDA and filed an official complaint. People DIE of bacterial infections…and for salespeople to mislead health care workers about the safety and efficacy of this product is criminal.
Why am I such a fan of essential oils as a potential safe ingredient but not this product that claims it does contain essential oils?
Simple…look at the ingredients: Organic Barbandenis Leaf (Aloe Vera) Extract, Carboxylmethylcellulose Sodium (Cellulose Gum), Organic Citrus Aurantium Dulcis (Sweet Orange) Essential Orange Oil, Organic MeleleucaAlternifolia (Tea Tree) Extract, Organic Azadirachta Indica (Neem) oil, Organic Citrus Medica limonum (Lemon) Essential Oil, Organic (lavandula Angustifolia (Lavander) Essential oil, Yucca Schidigera (Mojave Yucca) Extract, Geogard Ultra.
Note the mislabeled ingredients: Geogard Ultra is not a legal ingredient name; it’s a Brand Name for a synthetic preservative. The correct INCI-Name: Gluconolactone (and) Sodium Benzoate. A product that will kill germs on hands contaminated with bacteria would not need to have a preservative. It would not itself, grow germs. And yet this product contains preservatives. That is a red flag!
Here is a copy of my complaint:
Food & Drug Administration
Dear Ms. NAME REMOVED,
You may remember me from my complaint against the cosmetic company “100% Pure“. I believe at that time I also expressed concern about another company, Ava Anderson Nontoxic. Earlier this year, Ava Anderson announced her new product, a non-alcohol Hand Sanitizer made with essential oils. On Facebook, her salespeople are sharing how they are promoting this product to nurses in hospitals, to use instead of that “drying alcohol” hand sanitizer!
A few years back, when my Father was in the hospital, he contracted all kinds of bacterial infections. When he was in a coma in the intensive care unit, we learned how important it is to use the FDA recommended hand sanitizers to avoid spreading these germs to other family members and most importantly, patients. My Father might be alive today if everyone in that hospital had followed recommended sanitization procedures. He’s not…he died when his body was unable to continue to fight off those infections. So this issue is personal to me, but I also was made aware of the FDA’s increased attention to the issue of misbranded and illegal hand sanitizers recently.
Ava Anderson makes many of the same claims for her products as the Clean Well Company is accused of making in their FDA Warning Letter. I have included some quotes from various Ava Anderson Nontoxic websites and the websites of their salespeople. In addition, the company continues to make drug claims for their cosmetic ingredients, also a violation of the FDA cosmetics regulations. This company is not a local, Farmers Market-type company; this company is among the five national finalists in Entrepreneur magazine’s “Entrepreneur of 2011” awards competition. They are outspoken critics of the FDA, saying they are not doing enough to keep cosmetics safe, and have been featured more than once on the Campaign for Safe Cosmetics Facebook page as an example to other companies and consumers.
This company deserves to be exposed for all the laws they break! (And this does not even include all the USDA National Organic Program regulations they break with their false claims of having 100% Organic products, and organic ingredients in their products. They are NOT USDA Certified Organic and neither are their ingredients. But that is a separate battle.) I apologize for how disorganized the following information is, but I just copied and pasted and saved a bunch of web addresses. Please follow up on this company!! A warning letter to them would serve the entire industry as being on notice that the FDA DOES care about the safety of cosmetics, and are working to make sure companies follow the laws!!
Violates FDA regulations for hand sanitizer
Ava Anderson Hand Sanitizer 16 oz: “Organic Barbandenis Leaf (Aloe Vera) Extract, Carboxylmethylcellulose Sodium (Cellulose Gum), Organic Citrus Aurantium Dulcis (Sweet Orange) Essential Orange Oil, Organic MeleleucaAlternifolia (Tea Tree) Extract, Organic Azadirachta Indica (Neem) oil, Organic Citrus Medica limonum (Lemon) Essential Oil, Organic (lavandula Angustifolia (Lavander) Essential oil, Yucca Schidigera (Mojave Yucca) Extract, Geogard Ultra”
“Hand sanitizer set – When soap and water are not available, use our alcohol free hand sanitizer to promote clean, healthy hands without exposure to harmful chemicals. Organic essential oils work together to cleanse and moisturize hands naturally and safely. Leaves hands silky soft. No parabens, no phthalates, no triclosan, no sulfates, no synthetic fragrance or dyes. [HSA01] 16 oz bottle with pump and two, 2 oz purse/backpack sizes. Refill available”
“Non-Toxic Alcohol-Free Hand Sanitizer, with organic aloe and organic essential oils! Independent tests done show it kills 99.99% of germs!”
“Hand Sanitizer from Ava Anderson Non Toxic!!! www.MyNonToxicBiz.com NEW PRODUCT! Hand Sanitizer: As you know, we just launched our Non Alcohol Hand Sanitizer, with organic ingredients. We are so proud to supply you, your families and customer with this fabulous product. Please remember that there are very few competitors in the market (and now we are one of them). Many claim to be natural and use ethanol (same thing as alcohol), some claim to be organic and use benzalkonium chloride — a “6” (carcinogen) on the database. Most use triclosan, and other harmful toxic chemicals. Here is more information that you should be aware of:
Test results indicate that our sanitizer kills
>99.99% of common household and community germs, including those transferred from person to person, from animal to person and from hard and soft surfaces to person.
The following pathogens were killed at a percentage equal or greater to 99.99% within 15 seconds after exposure to the product:
• Gram-positive bacteria, including Staphylococcus aureus
• Gram-negative bacteria, including E-coli
• Viruses, including Herpes simplex Type 1 & Human Coronavirus
• Fungus, including Trichophyton
Specifically the tea tree and neem in our product and all of the organic essential oils have anti-microbial properties. Some interesting information concerning Alcohol-based hand sanitizers v. Non-Alcohol based hand sanitizers:
Alcohol is notorious for removing oil from skin. This oil is one of the body’s primary natural defenses against bacteria. Tests demonstrate that repeated use of alcohol based hand sanitizers can actually lead to increased bacteria on the skin over time. In other words, ongoing use of alcohol-based hand sanitizers become less effective the more frequently they are used. Not to mention, dry ,cracked, damaged skin.
Subjectively, users of essential oil based waterless hand sanitizers report a far greater level of satisfaction with the condition of their skin and hands. Almost 50% of individuals using alcohol based hand sanitizers report doing so at the expense of comfort and skin condition. Our AVA Hand sanitizer leaves your hands silky soft, form the organic aloe and essential oils. It is an amazing product, and it smells fantastic.”
In addition her cosmetic makeup claims are OTC drug claims;
“Foundation (light OR medium): French Clay is excellent for remineralization of the skin, absorbs toxins, and also purifies congested, acne-prone skin types. It improves blood circulation and makes the skin look radiant and hydrated, reducing the appearance of wrinkles and broken capillaries. Unlike synthetic powders, talc or titanium dioxide, silk has the unique characteristic of air permeability. Silk is full of anti inflammatory properties to help reduce puffiness; it helps with firmness of the skin and also contains natural sunscreen, protein, and other essential amino acids. Not only does silk act as a natural moisturizer, it assists in renewing old and damaged cells, thus reducing signs of aging, and reduces pigmentation like blemishes. “
“Blush: French Clay has rich mineral content and acts like a magnet for toxins. It improves blood circulation and makes the skin look radiant, hydrated, reducing the appearance of wrinkles and broken capillaries. It also purifies congested, acne-prone skin types. Silk powder has anti-inflammatory properties, helps reduce puffiness, maintains firmness of the skin, renews damaged skin cells, contains natural sun protection, and absorbs excessive oil, leaving the skin quite clear and soft. Reduces pigmentation such as blemishes. Natural anti-bacterial and anti-fungal properties. It relieves dry skin, soothes itchiness, redness and irritation, and improves general skin health and immunity, combating bacterial infections, including acne.”
“Lip Balm: Coconut oil is excellent as a skin moisturizer and softener. Beeswax provides soothing, softening, anti-bacterial and antiseptic properties that heal the skin and retain moisture. Sweet Almond Oil is easily absorbed, and helps to leave the skin soft and satiny smooth. Shea Butter has moisturizing and healing properties and is rich in Vitamins A, E, and F, and a number of other vitamins and minerals that help to soothe, hydrate, and balance the skin. They also provide skin collagen which assists with wrinkles and other signs of aging. This product is also beneficial for the treatment of itchy skin, skin rashes, eczema, dermatitis, wrinkles and chapped skin. Shea Butter offers a low level of UV protection (approximately SPF-6).” NOTE: claims SPF 6 but not labeled with active ingredients.
Sincerely, Susan Sawhill Apito
+++ Earlier this year I obtained a copy of the field report via the Freedom of Information Act.
The Complaint is number 2012-1162. CC#122040.
Initial Evaluation/Initial Disposition
Problem Keyword = labeling
Problem Keyword Details = False Drug Claims
Initial Evaluation = FDA Action Indicated
Initial Disposition = Surveillance Information for Next EI (means – this information would be looked at during the next scheduled inspection)
Disposition Date = 11/14/2011 Initial Disposition Remarks = REDACTED BY FDA
+++ I followed up with the FDA but my follow up questions were never answered. Am I satisfied with this outcome? Not so far – that is for sure!
Perhaps other more urgent issues prevented a Warning Letter being sent to Ava Anderson NonToxic. I don’t know. It was not clear to me from the documents I received, what, if anything, was done about the fact that Ava Anderson Non Toxic is selling an illegal hand sanitizer.
The FDA has an entire web page and has sent out press releases asking the public to alert them to illegal hand sanitizers. I did so, following the process that was explained to me. The product is still being sold and the company and their thousands of salespeople are still marketing this product as a superior alternative to the alcohol hand sanitizers the FDA recommends to consumers. I want to know why – and I want to know what is being done to stop them.
I filed a complaint, they are investigated…and yet nothing is done. Why? If the FDA regulations can be broken so openly and with the knowledge of the FDA agents…why even have laws?
While I am just a blogger with a mission – I do hope my article gets picked up by other websites – I think the public knowing that dangerous and illegal cosmetics are being sold by companies and even after an investigation, that these businesses just carry on business as usual and not even get a Warning Letter, is something the public needs to know!
Ava Anderson’s owners are outspoken critics of the FDA and the job they do. They regularly say “other” cosmetic companies are selling dangerous cosmetics – that is the centerpiece of their marketing – that “they” are the ONLY nontoxic cosmetic company IN THE USA! They tell their customers that they are at risk for cancer and other illnesses because the FDA does nothing to protect them…and yet their own company breaks the few laws for cosmetics that here are: they make illegal drug claims, use ingredients that are not FDA-approved as colorants and are selling an OTC drug that does not follow the FDA monograph.
I want to know what the FDA is going to do about this.
*What is an FDA Monograph? They are FDA regulations which outline specific active ingredients, doses, formulations and labeling for OTC drugs. Here is a link to a copy of the 1994 Tentative Final Monograph (TFM): www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4098B1_02_03-FDA-TAB1.pdf
(1) Clean Well Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251979.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=1994%20monograph%20hand%20sanitizer&utm_content=3