Healing Claims for Ingredients

dreamstime_s_46629883When you say that an product ingredient can heal, you are making the same claim for the product itself, so it  becomes an unapproved new drug.

As a perfect example, the FDA issued a warning letter to Sevani Botanica in mid-July in which most of the cited issues had to do with statements made about the essential oils in the products. Granted, the letter says there may be other issues (and looking at their webiste, I can see there probably were), but those were the ones they thought important enough to note in the letter.

From the FDA warning letter:

The claims on your website establish that the products are drugs … because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.

Advanced Omega Night Repair Serum

  • “Rosewood, and Neroli essential oils offer …cellular regeneration…”
  • “Evening Primrose: EFA’s reduce inflammation and protects from accelerated aging.”
  • “Neroli blossom: encourages collagen production…”

Eye Repair Age Defying Eye Crème

  • “Lotus blossom, Neroli and Rose: anti-inflammatory, regenerative…”

Ageless Eyes Revitalizing Eye Serum

  • “[E]ncourage collagen production…”
  • “Evening Primrose: anti-inflammatory…”
  • “Rose Geranium: strengthens capillaries to minimize discoloration”
  • “Helichrysum: Anti-inflammatory…”

Hyaluronic Wrinkle Defense

  • “Ideal for Rosacea too!”
  • “MSM: feeds the formation of collagen and elastin, preventing wrinkles, age spots and redness.”
  • “Panthenol (B5): anti-inflammatory…”

FDA Still Stepping Up Enforcement

I posted that the FDA was increasing enforcement activities in 2013 (FDA Cracking Down On Cosmetic Product Claims) and again in 2015 (FDA Warning Letters – Drug Claims for Cosmetics). The FDA is still on trend with increased warning letters – up through mid-July this year there have been 9 warning letters sent out concerning drug claims made for products marketed as cosmetics. That’s equal to the total number of similar warnings sent for all of 2015. No doubt about it, the issue is NOT going away.

Yes, it is “only nine” so far this year.  That’s is a low percentage for the number of small and large cosmetic companies out there, but it is still a marked increase over previous years, giving an indication of the FDA’s focus.  I don’t have any numbers or information on state-level enforcement activities but I expect that they are increasing as well.  (If you have any local level enforcement stories, please email me or post in the comments!)

What to Expect

Bottom line, expect more enforcement actions at both the federal and local levels. As funding for federal and local agencies increases, so will the amount of enforcement actions; certainly if they had more staff and more funding, the FDA would be doing more enforcement!

There has been legislation to increase cosmetic regulation introduced every year for at least the last 7 years.  This being an election year, the current bill will likely die a quiet death in committee.  However, we can expect some new bill concerning cosmetics will be introduced during the next legislative term. The Handcrafted Soap and Cosmetic Guild has been doing an excellent job with legislative advocacy, so we have hopes that whatever legislation comes up it will have minimal impact on the handcrafted soap and cosmetic industry.

If you make soap or cosmetics and aren’t yet a member of the HSCG, consider joining in order to help support their legislative actions. You’ll receive excellent member benefits to boot!

Keep in mind though, that even if any new legislation has exemptions for smaller businesses in terms of burdensome regulations (such as registration, reporting and fees, for example), it will still be likely to include provisions for increased funding.  With increased funding will come increased scrutiny, which will affect all businesses, large and small.

What to Do

As with most things, an ounce of prevention is worth a pound of cure.  

First and foremost, make sure that you understand the concept of intended use, and that you have clearly determined – for yourself – that the intended use of your products is within the legal scope of your production ability.  In other words, you shouldn’t be making drugs (either approved or unapproved) if you aren’t licensed, registered and inspected as a drug manufacturer at both the federal and state level.

If you try to get sneaky, thinking there is some way to tell your customer that the intended use of your product is to “treat acne” without the FDA figuring it out, it’s not going to work.  The FDA and most of their agents have been at this a lot longer that most of us have, and they’ve seen all the tricks.  Trying to get sneaky also means you’re likely to be looking over your shoulder (or the internet equivilent) waiting for the hammer to drop. Who needs that kind of stress?

When it comes to cosmetics and soap, check your labels, website, brochures, signage and other “labeling” to make sure that what you say about your products and their ingredients falls under the definition of a cosmetic (or soap).  Rewrite your copy as needed so you know that if the FDA ever did decide to take a look, you’d pass with flying colors. You’ll surely sleep easier.


  1. Thank you, Marie Gale, for all of your insightful postings. They are all, in addition to your great book, so helpful to the soapers and beauty industry. Because of what you teach and help us with, I have been able to “teach” my friends, family and clients about such things as “natural”, “organic” (and when one can use this word), and also be aware of claims that my friends make or requests they have for me to make a product.

    Have a great day!

    1. Author

      Thank you! I’m glad that the information has been of help.

  2. Excellent article. I have also been seeing an increase in enforcement. My best advice is never think that you are too small for the FDA to investigate.

  3. Great post and timely info, Marie – what is your take on using “anti-aging” in a product description? Since aging isn’t a disease or medical condition (thank goodness!), is this OK to say and still keep a product classified as a cosmetic?

    1. Author

      Anti-aging is tricky. It’s true that aging isn’t a disease, but it is a “function” of the body. To say that something is “anti-again” means, by the literal definition, that it is “against aging” and therefore would slow, stop or reverse the again process. That does, definitely, require altering the function or structure of the body (and it’s something that people have been unsuccessfully searching for a way to do for millenia). It’s similar to “youthful” or “younger” … no way you are going to actually get younger or more youthful. Anything that could actually make you younger or stop, slow or reverse aging would most certainly be a drug.

      On the other hand, there are products that can make you APPEAR younger, or reduce the APPEARANCE of wrinkles or old, dry skin (aging), but in this case you are talking about APPEARANCE only. It’ just makes you LOOK better (“improves appearance, beautifies”) — so it is a cosmetic.

      There is a fine line – even some of the big cosmetic companies have crossed it. Just remember that cosmetics only change how things LOOK, they don’t change anything functional or structural, and they usually don’t change things permanently.

  4. Thank you for raising the bar through education for smaller soap & cosmetic makers – who often have trouble wading through and making sense out of regulatory language! Very helpful to the members of the FB Groups I admin.

  5. I am so glad you wrote this article. I see so many products with claims on them. These products are made by many other people in the soaping industry and you would think they know better.

    After reading one of your previous articles, I have changed my soap names from Calamine soap to soap with calamine. I hope that is correct.

    Thank you again!

    1. Author

      Good for you! When designing your label, just make sure that “with calamine” is completely separate from the and identity (by spacing, color, font, etc) so that it won’t be considered part of the name or identity.

  6. After reading comments, someone pointed out the terms natural and organic. My issues are with the way soapers list products in places such as Etsy. When someone is listing ingredients and they use the term organic for one of the ingredients, it does not mean the product is organic. Some soapers want you to think the product is organic……
    Sorry, just one of my issues lately.

    1. Author

      Yes, “natural” and “organic” are problematic terms and so often misued.

      “Natural” isn’t regulated, so it can be used however you want (although there can be an issue of “false or misleading” information if one goes too far afield).

      “Organic” has been used in the ingredient declaration to signify an ingredient that was organic when received and added to the pot … but that doesn’t make the whole organic at all. Actually, when it comes to organic certification, I think that even opening an “organic” product in a non-organic-certified facility makes it lose is organic status.

      1. You are correct. In order for a Product to continue to be considered, the facility must have a. an Organic Material Handling Program in place and b. obtain the final certification.
        The Organic Handling Program is generally an addition to the SOP Manual. You can find examples online. However, the program is a little bit involved and would rightfully need its own separate post. In summary, this program ensures that the material is not co mingled with “non-organic” material during receiving, storage, processing, packaging and shipping. A plant can process both organic and non-organic materials in the same facility but steps must be taken to prevent cross contamination.
        Once you feel that your facility is up to standard, a USDA Certifier will inspect the plant and the program. These USDA Certifiers are usually through State Agricultural Colleges. For example, here in SC it is administered by Clemson University. I will say that these certifiers are amazingly helpful and will give you all the guidance needed to have an effective program.

  7. So now I’m wondering, if you sell, say, EO’s in a bottle, and make no claims on it’s packaging, and at point of sale only offer information on the EO’s attributes ( not claiming your product singularly does any one of them), would it still be considered a cosmetic? Young Living comes to mind, they make all kinds of claims about EO’s, both in general and pointedly, about their essential oils but I can’t find anywhere on their website that says that their EO’s have been approved(?), or whatever the process for drugs is, by the FDA to do what they say. I would think that if any of their oils had been approved that it would be something to be touted ( not something you would have to search for.

    From their website regarding their Thieves EO:
    “Put a few drops of Thieves essential oil blend in a capsule and swallow with water to support your immune system.”

    Overall, I guess I’m wondering how they are able to do this and make these claims. What is your take on it?

    1. Author

      Unfortunately, any information offered at point of sale about the attributes of ingredients is considered part of the “labeling” and thus used to determine the intended use. I was so shocked when I discovered this that I asked my local FDA Agent point blank … If I had a soap with lavender essential oil and I put a book on the table that was about essential oils and it said that lavender was antibacterial, would that be considered part of my “labeling”? Yes, it would.

      By definition, the “labeling” is what goes on or with the product. So a book (or signage) that says what the attributes of an essential oil are would be considered part of the labeling if it was provided to the customer for their information.

      In other words, you can’t have a book about essential oils on your table and when the customer says “What’s lavender oil good for?” and point them to the book.

      Young Living (and doTerra) got huge warning letters to the firm and some of the consultants for what they were claiming. I have no idea how they are working with the ingestion aspect – that would make the product a nutritional supplement. There are considerably different rules about what can be claimed for nutritional supplements than for cosmetics (which have allowed functional or structional change claims of zero).

      My take on Young Living and doTerra is they are working on getting everyone back on track with not making medical claims for the essential oils, but I don’t think all of the consultants have gotten fully with the program yet. It was such a major part of their marketing strategy that it I think it will be difficult to bring everyone back in line with the regulations.

  8. Marie, I have found your blog and books so helpful. I make products with kukui nut oil, which has some wonderful moisturizing properties. I like to educate my customers about ingredients whenever possible. In the past, this oil was used by native Hawaiians as a folk remedy.
    I would never make any medical claims for the oil myself. Do you think it’s best to leave the folk remedy information out?

    1. Author

      Once you start talking about ingredients being used as (or have been used as) remedies, you are walking into the area of drug claims. You could (maybe) get away with the idea that it’s been used by native Hawaiians for “many years” or “traditionally” … but NOT what it was used for or that it was used in traditional medicine of any kind.

      Of course, moisturizing is a cosmetic claim, so it’s acceptable. Traditional COSMETIC uses are acceptable (i.e. Cleopatra used various in her beautification procedures).

  9. Marie, thank you so much for your answer. Kukui nut oil (It was actually called candlenut by some) was used for lighting torches, however I would hope that someone would not take that to mean that my lotion could be used for home illumination purposes. However, better to be safe than sorry. Thanks again

  10. Hi Marie,
    Your information is SO helpful and useful, thank you.
    I have a Healing Salve, Diaper Rash Salve and a Sore Muscle Salve. Is that acceptable on the label if I just take precautions to make sure my description does not claim to specifically Heal any conditions? I also make Sugar Scrubs that I say on my website “great for those with Eczema and Psoriasis” . I’ve seen so many other companies that do the same, so I just assumed it was acceptable. I definately do not want to mislead my clients, or have the FDA come after me. Should I change any of the above?

    1. Author

      You should consider changing your labels. Anything that specifically says, or directly implies that the product is intended to “treat, cure, mitigate or prevent” disease or that will alter the “function or structure of the body” is considered a drug (a “new unapproved drug” when it hasn’t been approved). Healing (generally), diaper rash, sore muscles, eczema and psoriasis are all “diseases” and/or anything that can affect them is something that is altering the function and/or structure of the body.

      By naming your products in in those ways, and by including statements like “great for ___” on your website, you are essentially telling your customer (and the FDA) that the intended use of your product is to treat, cure, mitigate or prevent disease or alter the function/structure of the body. Not a good idea.

  11. Could you call a diaper rash cream “Baby Butt Cream” or something along that line?
    Specifically making sure to not make any claims regarding it’s ability to help heal, or does that imply to closely what is for?

    1. Author

      The name makes a difference, but remember that it is the intended use that determines the status of the product. If what you are trying to convey by the name is that it really IS a diaper rash cream, then the intended use is as a drug (to prevent or treat diaper rash) – and not as a cosmetic. If your customers recognize it as diaper rash cream, then so will the FDA.

      As an example, the FDA has cited product names like “Itch-B-Gone” or “No-Ouchy” as conveying to the consumer that the product’s intended use is to relieve itches or pain.

  12. But why can we not put a disclaimer that this product is not intended to treat, diagnose, etc.. ? You’ve seen the statements in nutritional supplements.

    1. Author

      You can put a disclaimer, but it’s NOT the same as the disclaimer that is used for nutritional supplements. You’d need to see your attorney to get a disclaimer that might — **MIGHT** — protect you.

      The disclaimer for nutritional supplements is VERY exact, covered in the regulations for nutritional supplements, can only be used in some very specific situations and requires reporting to the FDA when you use it.

  13. Hi Marie, thank you for all your great info! I have a question about adding a disclaimer to my soap labels. I don’t make any claims omit or anywhere, just call it soap. On the back with the ingredients and other info listed I say “if you are allergic to any of these items, do not use”. Should I leave it off? Is it opening a can of worms or is this ok? Thanks again,

    1. Author

      It’s not really a “disclaimer” — it’s more of “directions” — which are always acceptable. If you feel it’s important to add the statement about allergies, then do so. Remember that on soap, the ingredients are not required.

  14. Hi! Thank you for the great information! Are there words that are “safe” to use and do you have a list? I’ve been using “Soothing”, “soothes” pain, but now I’m wondering about that.

    1. Author

      There have been a couple of lists published of “acceptable words”, but the WORDS are not really the point. The point is whether you intend the product to change the body somehow (structurally or how it works) or whether the product is just for appearance sake.

      If you “soothe” that could go either way. If you soothe pain, you are most certainly changing the function or structure of the body (or healing, mitigating or curing something wrong with the body). If you “soothe” emotionally (e.g. relax or calm) it’s generally considered okay, unless it is stated with regards to a labeled “mental disease” (anxiety or PTSD, for example).

  15. Marie, if an ingredient that you are using in your cream, soap etc., has been approved br the FDA as a treatment or healer can you then say that on the label

    1. Author

      The FDA has approved certain “active ingredients” for use in OTC (over-the-counter) drugs. The specifications are called “Monographs” and are contained in the regulations. For example, putting 12.5% to 50% lanolin in a product qualifies it as a “skin protectant”, and allows certain claims to be made, provided the product is correctly labeled AS A DRUG.

      BUT (and this is a BIG BUT) — the product is a DRUG. Even though you could make a product that meets the requirements, you would have to be an APPROVED DRUG MANUFACTURER (along with the fees, registration, inspection, etc etc) that entails. No WAY any handcrafter would ever be able to meet the detailed good manufacturing practices required.

  16. Marie – I am a reseller but as you mentioned any statements made up until point of sale is related to the product claims and I can be responsible and/or reprimanded by the fda. 1). I need to refer to these cosmetics as “feeling” “appear” “appearance” “look” “this oil was traditinally used by geishas for its help in appearing flawless?!” Other terms to use?

    2) when it is a drug can you sell it or do you need differet status? For example some vendors have claimed their products are for excema, anti aging, etc. Is there a list of these monographs?

    3) i am describing these products on my site as I resell them on my website and want to stay well within the law!!

    Thank you!

    1. Author

      You’re on the right track with the “feeling” “appear” “appearance” “look” approach. Cosmetics improve the appearance, cleanse and beautify … all temporary, surface changes.

      If the product is a drug, it must be approved by the FDA or meet the monograph for the over-the-counter use. AND, it must be LABELED as an over-the-counter drug. If it doesn’t meet BOTH those criteria, then it can’t be marketed as an OTC drug. You could tell just by looking at the product labeling.

      The OTC monographs are covered in the regulations 21 CFR 330-358. Links to each section are listed on this page: https://www.ecfr.gov/cgi-bin/text-idx?gp=&SID=7200fa0dd9d97efe945b0fd00270b236&mc=true&tpl=/ecfrbrowse/Title21/21CIsubchapD.tpl (or if that links doesn’t work, go to http://www.ecfr.gov and search for 21 CFR 330.

  17. And with all otc monographs you can market the substantiated drug claims. For example sunscreen is in the list ecfr.gov. So this you could say more than the “improves the appearnce” “cleanses” beautifies”….

    Thank you so much. You are such an amazing resource for those who are trying hard to do it correctly!! Have a wonderful day!

    1. Author

      Yes, that’s true that you can use the approved wording … just make sure that the product is correctly manufactured (by a drug manufacturer) AND is correctly labeled as an OTC drug.

  18. So, since many many products can fall under this DRUG category, where do we find all of the detailed information for being a DRUG manufacturer? I know you stated it’s costly etc, etc, but just for future reference, OR are there drug manufacturers that will manufacture your recipe for you?

    1. Author

      There are cosmetic manufacturers that hold the necessary approvals and certifications to make over-the-counter drugs (like lip protectants, acne cream and such like). Happi Magazine has a Directory of Private Label Manufacturers which might be a good place to start. Be aware, though, that the minimums can be pretty high.

      As for getting registered yourself, the FDA’s page Registration and Listing is a good place to start. The biggest issue for most is complying with the Good Manufacturing Practices which are in regulations. I don’t know where there is a “common english” version, but the regulations can be found in Code of Federal Regulations, Title 21, Parts 210 and 211.

  19. Hello Marie and thank you so much for all this information!

    Can someone sell a sunscreen in any way (I mean as a handmade seller)? Is there a problem selling bug repellents?
    Thank you so much for your replies!

    1. Author

      Sunscreen is regulated as a drug. In order to make and sell a product that claims to be a sunscreen it must be made with known sun blocking agents, tested to verify the SPF, and manufactured in an approved and licensed drug manufacturing facility. Also note that the ability of handcrafters to make reliable sunscreen is limited do to the nature of the ingredients and how they go together.

      Bug repellents are regulated by the EPA. In order to make and sell a bug repellent, the product must be either approved as an insecticide (MAJOR thing to accomplish) OR the active ingredients must be on the pre-approved list of reduced-risk active ingreidnets (things like neem and citronella) AND the inactive ingredients must be on a different preapproved list (or be generally regarded as safe food items) except not essential oils or spices.

      1. Thank you so much Marie!
        I read all the EPA regulation about bug repellent. So, just to be sure, I see it is ok to sell a bug repellent made with sunflower oil and essential oils of cedarwood, citronella and lemongrass (I saw that they are in the list of the active ingredients). Thank you once again!

      2. Author

        So long as the ingredients are on the list(s), you are okay. You do need to label with correct insecticide labels, which included denoting the percentage of the active ingredients and may require some other language. Check the EPA website for the details.

  20. I was wondering if it is ok to say the components of its herb. For example can I say “Rose hips are full of Vitamin C and iron?” or “olive oil has antioxidants” or say that an ingredient is powerful?

    1. Author

      You can say what components are in the ingredient, but you can’t say or imply what those components DO (unless it’s just to beautify or make more attractive). “Powerful” doens’t claim that it would treat, mitigate or prevent a disease, or that it would alter the function or structure of the body. By itself, it would be okay. However, in certain contexts combined with other statements it could be moved into the “drug claim” arena.

  21. Hi Marie, I am seriously confused by alot that people are doing and what is being said and not said: from reading your blogs i would gather the next content is making drug claims ” Muscle Rub is designed to help target aches with a calming and cooling sensation. This formula works wonders after jogging, athletics or a long work day.

    Ginger has long been recognized for its value as a natural anti-inflammatory remedy. The ginger plant contains powerful compounds called gingerols that may help reduce the tissue inflammation that causes stiff, aching muscles and joints. ” but this is from a cosmetic line and a popular cosmetic private label company. Other compliant companies host muscle rubs and say how “joints will love the benefits…..” How does one go about describing a lotion that has menthyl and other cooling ingredients that is intended for use on arms and legs after a run.?

    1. Author

      Yes – there are many herbs that can help with many ailments. And yes, there are a lot of companies out there making claims that far exceed what is legal.

      Bottom line, though, is that the only, repeat ONLY, way to legally promote and sell a product that is intended to help with muscles after a run is meet the standards for an over-the-counter drug (which uses pre-approved ingredients) OR to get it approved as a new drug (not feasible for a small company). Keep in mind that even if you could meet the OTC requirements, you would still need to be registered as a drug manufacturer in order to make it.

      Ben-Gay, for example, is an over-the-counter drug. You can tell because the label lists “active ingredients” and “other drug facts”. Camphor, methol and methyl salicylate are approved for use as topical anagesics. It looks like the final rule was submitted in 1983, but is not yet added to the actual regulations. You can read the proposed rule (which I think is what is currently the guiding rule), here:
      http://cdn.loc.gov/service/ll/fedreg/fr048/fr048027/fr048027.pdf#page=138 The proposed regulation is about 15 pages down (page 5867).

  22. So the verbiage “muscle rub” or Active Cream” are drug claims….what would be a way to and verbiage for a product like this that is compliant to cosmetic regulations?
    Thank you Marie, You are a godsend and a deep well of knowledge thanks for sharing.

    1. Author

      Well, that’s the thing. It’s not the verbage – it is the intended use. If the intended use is as a muscle rub, then it is a drug. that’s all there is to it. If you plan to communicate to customers that the reason for the product and its intended use is to relieve muscle pain … then you have an unapproved new drug.

      The only way to keep it within the cosmetic regulations is to MAKE NO CLAIMS and don’t try to tell your customers to use it as a muscle rub. If they can figure it out, so can the FDA.

      1. “Muscle Creme”- Rub in deeply this rich formula and reap all the skin, muscle and joint loving benefits of this super powered ingredient. Tired muscles and joints seemed eased and relaxed, while skin feels more soft and supple.

        This is what a reputable brand has and when i talked to them they said none of these are claims> im like “How is this not a claim”?

      2. Author

        It’s like traffic laws … they exists and people usually know what they are, but make a calculated risk to ignore them. Right up until they get a ticket (or get into an accident). My advice is to make your own informed decisions about your own products and your business model. Basing your product positioning and marketing on something that is technically agaisnt the law is risky. Back to the traffic laws – it’s like basing a delivery service on the fact that the drivers can always go 10 miles over the speed limit. It will work for a while, but probably won’t work in the long run.

  23. Thank you for this helpful article. I am a soap maker planning on opening a business soon. I was wondering if you know about such statements, for example, like “Calendula has been used for hundreds of years by the ____ people to reduce/improve ____.” Since it is not a direct claim that the ingredient cures/treats _____, would something like that be ok? I love studying traditional herbal medicine and including herbs that have been used by ancient peoples in my soaps, and would love to let people know the history or those ingredients, but don’t want to be misleading or get into trouble. Thank you!

    1. Author

      Claims made for ingredients, including “traditionally used for …” and similar statements, all convert to claims for the product. Why make the statement if you aren’t implying, in some way, that the information about the ingredient holds true for the product itself?

  24. Marie, First I bow to you for answering every question that’s been posted. Hands down to your soul for helping each and everyone of us. My question is I have a small business where I make products from herbs, spices and essential oils like back pain salve, sinus salve, menstrual cramp oil. Yes the purpose of the product is to deliver the benefit (because the herbs, spices plant based have been used as ancient remedies for centuries ) like support back pain/ sore muscle, help reduce menstrual cramp by rubbing the oil on the cramping areas like legs, back. Products do not claim, diagnose or cure anything and not approved by FDA Label says it, How can I name or market the products?

    1. Author

      I’m sorry to say that the bottom line is that if the product is intended to treat or mitigate disease (which seems to generally include physical issues) OR if the product is intended to alter the function or structure of the body (that would be changing cramps, clogged sinuses, muscle cramps and pain, etc) … then the product IS an unapproved new drug.

      If the consumer comes away from the product label and labeling (all the stuff that goes with it – brochures, signs, website copy, etc) with the idea that their physical issue will be addressed and their body changed somehow … then the product is an unapproved new drug.

      You can’t say that the ingredients are “traditionally known for ___” or have been “used for centuries for ___” because that gives the consumer an idea of what the PRODUCT is intended to be used for. Images, wording, product names, etc that tell the consumer that there problems will be treated again make the product become an unapproved new drug.

      You CAN (and must and should) put all the ingredients in the ingredient declaration. You can highlight some of the ingredients in the marketing text (without saying what they are for). A savvy and educated consumer is likely to purchase based on their understanding of the ingredients.

      Not the greatest news if you have a product that you feel could help people.

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