Waterless Hand Cleaner

BobzchemistBobzchemist Member, PCF student
edited June 2015 in Cosmetic Industry
I've been asked to formulate one of these, and my survey of products on the marketplace tells me that a large proportion of the manufacturers of these products clearly don't think that the FDA Cosmetic Regulations don't apply to them, particularly those products that are sold as industrial products, and not as consumer/retail products.

My understanding of the FDA regs tells me that (from the website) The 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)).

I don't see where there's any exemption for products not sold to the general public. Does anyone know of anything I've missed? It would certainly make my life easier if I didn't have to comply.
Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
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Comments

  • perspicaciousperspicacious Member
    edited June 2015
    Bob, this is an excellent topic which is an ongoing interest of mine because industrial use products comprise a good part of what I develop and manufacture.  For years I enjoyed the carte blanche freedom which allowed some rather daring formulation techniques, however, as time progressed over the last three decades I became more skilled (informed) and I learned to appreciate and value products which are non-toxic and sensitive to the environment.  

    I have in recent years become an advocate in my business practices for product safety (personal and environmental), including accurate product claims and appropriate labeling. I now impose very strict standards in my own developmental discipline. 

    But, as I have been adhering in my formulations to rigid rules regarding safety and disclosure I have been puzzled by the lack of compliance and enforcement of the in place regulations, specifically regarding labeling and use of certain ingredients. 

    From my understanding, industrial skin cleaning products (including those for auto mechanics) are to be regarded as cosmetics and the same regulations apply (regarding labeling, safety and claims).  I know I have seen that information, but I would like to find current links to the documentation. 

    Not only are there the FDA cosmetics regulation considerations, but there are OSHA requirements which include the new SDS (they dropped the M), safety data sheet reporting requirements.  However, I noticed in the instructions for the SDS that they seem to allow "trade secret," which appears to take away any need for disclosure. Look at section 3 about trade secret in the following link: 


    I have seen some industrial hand cleaners where "proprietary ingredient" is listed on the label and in their SDS and if that complies to the rules then all the teeth is taken out of the reporting requirements.

    California has led the way regarding regulation with their Proposition 65 which includes a list of forbidden ingredients which could find their way into the water supply (down the drain). The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents.

    From what I have read, the EPA is adopting the California provisions nationwide.  I'd like to find that link again as well.

    California has also been the leader in the regulation of volatile organic compounds (VOCs).  They publish a list of ingredients which can't be used in commercial products in California.  Ingredients found in some waterless hand cleaners are on that list (d limonene and dipentene, among several others).  From my understanding US regulation will soon duplicate the California VOC laws (where I saw that I don't know right now... link needed).

    I would like to see a compilation of links (or quotes) of what's current and coming in regulations regarding cosmetic products.
  • PerryPerry Administrator, Professional Chemist
    Perhaps they are considering themselves "professional products" which the FDA doesn't regulate the same way.  For example, here they say (with regards to labeling) 

    "This requirement does not apply to cosmetics distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities."

  • perspicaciousperspicacious Member
    edited June 2015
    Perry,

    That is a very good observation.  That "workplace" reference is quite significant.  

    I interpret that to mean that if I am selling hand cleaning products distributed "solely" for use in factories and shops that no ingredient label is required under FDA regulations. That's interesting for test marketing innovative items where I wish to keep the concepts confidential for a limited time.. 

    Some of my products fit that definition, but others, sold in hardware stores and auto parts stores (or any place which sells to the public),do not.  Even large industrial distributors (like Grainger) while selling for the workplace, are open to the public (negating the "sold solely for the workplace" exception).

    That still leaves the OSHA SDS ingredient listing regulations, which certainly applies to the workplace.   That "trade secret" provision I mentioned in the SDS instructions looks similar in wording to the FDA trade secret provision, but that FDA one is quite detailed that you must apply for approval to the FDA for using a trade secret exclusion and those requirements are quite stringent. I am searching to find if there is a similar OSHA provision for applying for approval to designate an ingredient as a "trade secret."


    If the SDS trade secret exception provision requirements are the same as the FDA then that's not really an option for ingredient listing on the SDS.   If that's the case, then there are many "waterless hand cleaner" products on the market which have deceptive information sheets (as Bob seems to have observed). One main player waterless product is listing (on both label and SDS) as a primary ingredient, "microemulsion gel" with no disclosure as to what makes up that mysterious gel.

    In the realm of cosmetics labeling (and especially in the hand cleaner segment) there is a lot of "what can I get away with?" thinking as opposed to "what is the right and legal thing to do?" mentality.

    I am really glad that Bobzchemist broached this subject.  If I have a new waterless formulation which is superior to existing market items, I want to be on a level playing field with what's out there in reference to labeling and SDS ingredient listing requirements.  

    So I am very much am interested in seeing this topic explored fully

    .
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