annmarie skin care FDA Compliance Protocol
We appreciate our relationship with you. Thank you in advance for staying in compliance with the FDA’s guidelines so we can all continue to grow and work successfully together.
Pursuant to the Food, Drug & Cosmetic Act, the FDA and FTC require that we follow a very specific and detailed protocol about what we can say about our products online, over the phone and in person. Anyone working for Annmarie Skin Care, including our affiliates, must adhere to this protocol to ensure that our company maintains good standing with the FDA and other regulatory agencies. As an affiliate, you are responsible for what you say about our products to others. What you say could affect our standing with the FDA, so if you’re not sure if you can say something, please ask and we can help clarify.
why is fda compliance so important?
Essentially, they can and will shut down any company that makes drug-like claims or “structure- function” claims for their products. This includes claims made by any team member or affiliate on our website, your website, via email, over the phone, or in person. Many companies continue marketing their cosmetic products by making illegal claims. Comparisons to what others may claim is not helpful, and in fact, can put our company in jeopardy.
what are claims?
A drug-like claim:
• Suggests that the product is intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease”
• A structure-function claim can be made for a dietary supplement, but NOT a cosmetic.
A structure-function claim suggests that products are “articles intended to affect the structure or any function of the human body.”
In addition to statements that expressly claim to diagnose, cure, mitigate, treat, or prevent disease, the FDA lists ten different ways that a company can make an illegal, implied disease claim.
These include, for example:
• A statement that the product or ingredient has an effect on the characteristic signs or symptoms of a disease; This can be as obvious as “our Citrus Stem Cell Serum helps cure your redness from rosacea” to the not so obvious “our Anti-Aging Facial Oil removes redness in the skin.”
• A statement about the product or ingredient, that cites a scientific publication that refers to disease treatment; Citations must NOT contain reference to what an ingredient or product can do to treat a disease or symptom of a disease. An example of this would be—We write an article on herbs for uneven skin tone, and cite an article that shows licorice root can help with hyperpigmentation. Even though we say that “studies show that licorice root can help even skin tone”—we:
1) can’t link to the study or show it and
2) it’s a better approach to not even mention that studies show anything. This should simply be stated that “licorice root can help with the appearance of uneven skin tone.”
• A statement that the product or ingredient is a substitute for a therapy for a disease
Examples—“Annmarie Skin Care’s Kaolin Micro Exfoliant is a natural microdermabrasion treatment.”
Or “vitamin E is a natural botox.”
• A statement that the product or ingredient has a role in the body’s response to a disease.
Products can’t say they do anything to the response the body has when it has a disease. An example of this would be “Annmarie Skin Care’s Citrus Mint Cleanser can help with the inflammation caused by acne.”
• And there is a catch-all: Otherwise suggests an effect on disease.
For example, you cannot say: “Annmarie Skin Care’s products cured my rosacea.”
other non-approved claims
- Treats a disease (such as acne, eczema, hyperpigmentation, psoriasis, or rosacea)
- Increases collagen
- Revives cells
- Regenerates skin
- Increases cell turnover
- Stimulates circulation
- Anti-inflammatory
- Antimicrobial
- Anti-viral
- Antibacterial
- Antiseptic
- Heals burns
- Heals wounds
- Changes mood
- Anxiety
- Acne
- Breakouts
- Blemishes
- Blackheads
- Headaches
- Aphrodisiac
- Astringent
- Shrinks pores
- Cold
- Flu
- Hormone balancing
- Microdermabrasion
- Repair free radical damage
- Repair skin
- Heals scars
- Stimulates collagen production
- Stimulates hair growth
- Repairs sun damaged skin
- Sun spots
- Hyperpigmentation
- Supports cell communication
- Insomnia
FDA warns that the drug claims include:
• Claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery.
• Promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.
Please keep in mind, this refers to not only the product over all, but when talking about the specific ingredients in the products.
Additionally, the FDA gives the following as examples of claims cosmetics may not make. Here is a short list, please review the rest here.
what claims can be made?
The FDA gives the following as examples of claims cosmetics may make:
• Cleanses skin For example: “Cleanse and lift excess oil with Annmarie Skin Care’s pH-balanced, aloe vera-based Aloe Herb Cleanser.”
• Enhances beauty
For example: “Resveratrol-rich knotweed, plant-cell extracts and copper combine to help keep skin moist, plump and supple for an overall even-toned, luminous glow.” {Wild Fruit Serum}
• Promotes attractiveness
For example: “Indulge, electrify, and be sensual. A warm and sweet essential oil blend to help you relax and awaken your sensuality.” {Passionate Pure Essential Oil Signature Blend}
• Alters or reduces or minimizes the appearance of
For example: “Annmarie Skin Care’s Anti-Aging Eye Cream reduces the appearance of fine lines around the eyes.”
• Exfoliates
For example: “This {Micro Kaolin Exfoliant} revitalizing treatment exfoliates skin, while leaving it polished, flawless and restored.”
These are general examples, but as long as the claim falls into one of these categories, you should be safe.
If you’re unsure, please ask.
To view our full FDA Compliance Protocol, please click here.