FDA Upping Their Game for Cosmetics

warning letters graph

The FDA just updated their Warning Letters Address Drug Claims Made for Products Marketing as Cosmetics Claims page with yet more warning letters. That makes twenty-five warning letters issued so far in 2016. And of those, 18 were issued in just the last 3 months! Compare that to nine warning letters in 2015 and only two issued in 2014 and it’s easy to see a pattern.

What are the Violations?

Here is a quick sampling of the types of violations the FDA is citing. These are the “drug claims” made for products marketed as cosmetics that the FDA found on product labels and in product descriptions, websites, and ingredient details.

  • “Minimizes swelling when applied soon after skin trauma” (product claim)
  • “Lavender… is an antidepressant and is used to calm a stressed spirit, anxiety, and hysteria.”
  • “Emu oil is anti-inflammatory, anti-bacterial and anti-microbial…”
  • “Relieve itching due to poison ivy/poison oak or any other skin irritation, including eczema and psoriasis” (jewelweed)
  • “Rose hydrosol enhances circulation in the skin for cellular regeneration.”
  • “Helps stimulate cell renewal” (product claim)
  • “Powerful antioxidants help defend against environmental triggers that cause pigmentation.”
  • “Commonly used in areas of Brazil to treat inflammatory and painful diseases…” (Mirabilis Jalapa Extract)
  • “Rosemary Leaf Extract has antimicrobial properties…”
  • “Stimulates healthy collagen production…” (product claim)
  • “Spanish Lavender helps inhibit muscle fiber contractions to decrease the look of expression lines.”
  • “Rosehip CO2 and Pomegranate CO2 seed oils help rebuild collagen”
  • Honeysuckle, Jasmine, Rose Damascena and Carrot Seed Hydrosols aid in reducing skin inflammation…”
  • “Frankincense essential oil has antibacterial and anti-inflammatory benefits to the skin, making it ideal for acne-prone skin.”
  • “Specially formulated shampoo for those who have Exzema or Psoriasis in the scalp area.”
  • “Neem is anti-viral, anti-fungal, and anti-inflammatory”
  • “Several studies of Neem extracts in suppressing malaria have been conducted, all supporting its use in treatment.”
  • “These essential oils can lower your blood pressure and help hypertension.”
  • “Motherwort – A hypotensive”
  • “Cayenne – helps lower blood cholesterol levels; to reduce blood pressure, cardiac problems, lipid levels.”
  • “Neroli promotes cell growth”
  • “Natural sun protection. Ultra-hydrating formula encourages healthy cell regeneration” (product claim)
  • “Uses frankincense to balance hormones” (product claim)
  • “An excellent alternative to medically administered treatments” (for a lip volumizer)
  • “Safe and non-toxic, topical alternative to injections” (for an anti-wrinkle product)
  • “Activates epidermal regeneration and targets damage done by free radical agents” (product claim)
  • “Helps soothe and has been known to provide anti-inflammatory benefits” (product claim)
  • “A natural alternative to Botox and other potentially harmful (and costly) invasive procedures” (for a wrinkle treatment product)
  • “Anti-bacterial, anti-viral, anti-fungal and anti-parasitic” (for a face toner)
  • “The combined organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter (SPF 6-10) assist in providing natural sun protection.”
  • “Natural vitamin E is known to… help skin recover from scarring and other damage.”

This is JUST a sampling of the claims cited and is only for some of the warning letters issued in July and August, 2016.

You’ll note that many of the claims made are for natural ingredients and essential oils, and if you research online, you’ll probaby find that there are authoritative documents and even scientific studies to back up at least some of the claims made above. You may have even used vitamin E on a scar, lavender essential oil to treat a headache or stress, or jewelweed to reduce itching.

Unfortunately, the point is not whether or not the product or ingredients provide the benefits claimed. The point is that cosmetics and drugs are different things and you can’t make drug claims for cosmetic products.

Cosmetics vs. Drugs

A cosmetic only changes the appearance, and a drug changes the physical  function or structure.

Cosmetics and cosmetic manufacturers are not heavily regulated. They don’t require advance approval and (for the time being) don’t have to register with the FDA.

Drugs and drug manufacturers, on the other hand, ARE heavily regulated. Drugs must be pre-approved (a lengthy and expensive process) or meet already approved standards (for over-the-counter products). Drug manufacturers must register with the FDA and meet good manufacturing practices as established by regulations.

If you want to make cosmetics, then the product and ingredients can only claim to do the things that cosmetics can do (by the definition in the law).  That includes cleansing, improving appearance, and beautifying.

If you want to make a product that does more than that, a product that will alter the function or structure of the body or that will cure, treat, mitigate, or prevent a disease, then you need to become a drug manufacturer, follow all the pertinent drug manufacturing regulations, and get appropriate approvals for your drug products.


There is no doubt that the FDA is increasing their vigilance and surveillance of cosmetic products and manufacturers and issuing more warnings than ever before.

If you make soap or cosmetic products and want to keep out of the FDA spotlight, it would behoove you to review all your product and ingredient descriptions, product labels, and website content to make sure you are staying within the definition of a cosmetic for all your products.

Bottom line: Don’t make drug claims for your products unless you are willing for the FDA (or a State agency) to come a-knockin’ on your door.

Soap and Cosmetic Labeling cover

To really be able to create your own labels that comply with the regulations, get my book from Amazon and use it.


14 responses to “FDA Upping Their Game for Cosmetics”

  1. Stacy sibley

    I am wondering I am looking into making bath fizzies technically a bath bomb but not in a circle more square shape but anywho I am trying to figure out what is color appropriate FDA standards I know it has to be skin and I safe is there any regulation against using food coloring to color bath bombs and if I decide to make and sell them am I allowed to state that it would leave your skin soft after use

    1. Bath fizzies and bath bombs—anything that you put in the bath like that—are cosmetics.

      The color needs to be approved for use in cosmetics. See this blog post: Color Additives for In-Bath Products for more details.

      I would NOT recommend using food coloring to color bath bombs as you can’t determine exactly what’s in them and if it is approved for use in cosmetics. Get your color additives from a reputable supplier of ingredients for handcrafted cosmetics. See Where to Buy Supplies page on the Handcrafted Soap and Cosmetic Guild website for a list of vendors. Some of those vendors offer discounts to members of the HSCG.

      Finally, it is okay to say that using it would make your skin soft. That is a cosmetic claim.

  2. So if I make bath bombs, for example, and in their description I say “they will make your bath water smell amazing” or “they will make bath time fun” , I would not be in violation?

    1. Marie Gale

      Since amazing smelling bath water and fun bath time do not claim to alter the function or structure of the body, or to treat, cure, mitigate, or prevent a disease—you are safe. Keep in mind that bath bombs ARE cosmetics, so you need to have the full ingredient list on the label.

  3. Hi Marie, I simply wanted to thank you for being such a wonderful resource for small batch makers like myself. This is very helpful information.

    1. Marie Gale

      You’re very welcome—I am glad that it helps.

  4. WHAT words can we use? Is there a list anywhere? Soothes dry cracked skin? Encourages skin healing? Can I say that?

    1. Marie Gale

      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 appearances sake.

      If you “soothe,” that could go either way. If you soothe dry cracked skin, I assume you mean that you are actually doing something about it, so you are changing the body. If you “encourage skin healing” you are doing something to the body so it heals better.

      Cosmetics only allow a change of appearance—no change of structure or function.

  5. Ronnette Curls

    I have a question I have a product it says Itching Scalp Telief and impeccable Anti-Aging Cream .I am not stating or claiming it can releve your itching scalp nor make you look younger in the product description, however, will I need to adjust the title/ labels if it states just that? But doesn’t imply ? or is the name on the label speaks for itself and do I have to change it? I have another question I gave essential oil references on my website but I did it based on someone’s elses claims in book about preventions, but am I still liable under the treatment and prevention claims? I am in the process of building my website. Thanks
    Thank you for listening

    1. If you call it “itching scalp relief” or “impeccable Anti-Aging Cream” you are stating that the intended use is for itching scalp or anti-aging. That makes the products unapproved new drugs.

      Giving essential oil references that state preventative, healing, or curative properties (unapproved new drug claims) on your site OR LINKING TO A SITE THAT MAKES THOSE STATEMENTS constitute statements about the intended use of the products that contain those oils. Essentially they become claims for YOUR products.

      If you are making a product that is INTENDED to treat itching scalp, then you have an unapproved new drug. There isn’t a way to communicate that to your customers without also making it clear to the FDA that that’s what you are making the product for. The FDA isn’t stupid.

      The best you can do is to put the product out there without any statements WHATSOEVER about anti-itch (for the product, in the name or in the ingredients) and then list the ingredients. If you are relying on essential oils, then list the essential oils; but say NOTHING about their treating itching. If the consumer is savvy, they will figure out what the essential oils do (in addition to fragrance).

      It’s difficult when essential oils really can make such a difference and really do have terrific properties.

  6. I do not put any claims on my actual product labels but I do use essential oils. I like to study the essential oils and write about their properties and what they can do for the body “anti-bacterial, anti-inflammatory, ect.” I share these with my customers through written articles and advertising. Am I in violation? How do essential oil companies get away with it?

    1. Marie Gale

      Your website and promotional materials (including books you put out on display with your products and signage) are considered part of the “labeling.” The label (on the product) AND labeling are used to determine the intended use of the product. If you say that “tea tree oil is anti-bacterial” and then say that your product includes tea tree oil, that “claim” of being anti-bacterial attaches to the product(s) containing tea tree oil. It’s part of the “intended use” of the product. Otherwise, why would you be making the statement in the first place? (So the logic goes.)

      Essential oil companies that are marketing to manufacturers are not restricted by the regulations that apply to products for CONSUMERS. So a wholesaler can say whatever they want. Some essential oil MLM companies have already gotten into hot water with the FDA for the claims they’ve made.

  7. According to a senate hearing I watched on the Epipen, the FDA increased hiring so this trend is bound to continue.

  8. Thank you Marie for the informative update to keep us all on track and keeping me aware of important changes in the happening at the FDA.

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