Denver District Office
P.O. Box 25087
Denver, CO 80225
June 02, 2017
VIA EXPRESS DELIVERY
Ann Dalton, CEO & Founder
Perfectly Posh, LLC.
222 South Main Street Ste 1600
Salt Lake City, UT 84101
Re: CMS: 520135
Ref. #: DEN-17-08-WL
Dear Ms. Ann Dalton:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.perfectlyposh.com/p/ in March 2017 and has determined that you take orders there for the products Share Skin Joy Coconut Oil, Goodnight Kisses Overnight Lip Mask, Purifier Snarky Bar, Call it a Night Nighttime Facial Oil, and Lemon Wedgie Caffeinated Lip Balm. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Share Skin Joy Coconut Oil:
- “Coconut oil … is known to help treat eczema, psoriasis, and can even help treat and prevent acne.”
- “Rosemary Leaf Extract … is helpful in treating skin issues such as acne, eczema, and chronic dry skin.”
- “Sunflower seed oil … is effective in combating acne, eczema, inflammation, redness, and irritation.”
Goodnight Kisses Overnight Lip Mask:
- “Mango Seed Butter also aids in cellular regeneration and is excellent for soothing sunburns…”
Purifier Snarky Bar:
- “Eucalyptus oil functions as an anti-inflammatory, antiseptic, and antibacterial ingredient. The oil is also a skin-conditioning agent used to treat skin infections and help alleviate skin irritation.”
- “Peppermint oil is used to relieve skin irritation, itchiness, and redness where inflammation is present. The high menthol content of the oil is also known to allow blood vessels to relax and improve circulation.”
- “Tea tree Oil, also known as Melaleuca Oil, has anti-microbial, anti-viral, and anti-fungal properties which help with the treatment of acne, dandruff, rashes, sunburns, and other skin conditions.”
Call it a Night Nighttime Facial Oil:
- “Lavender Oil has anti-inflammatory and antimicrobial properties and can soothe minor burns and insect bites.”
- “Green or White Tea Extract has strong antimicrobial … [and] anti-inflammatory … properties.”
- “Safflower Seed Oil … is known for its ability to treat psoriasis, eczema, and acne.”
Lemon Wedgie Caffeinated Lip Balm:
- “Caffeine… acts as an anti-inflammatory… and can help protect the skin against sun damage.”
- “Shea Butter… is effective in improving or treating skin inflammation and irritation such as burns and acne, dark spots, eczema, and psoriasis.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products on your website that are intended for use as drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice, such as seizure or injunction.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to the U.S. Food and Drug Administration at the address below, Attn: Nancy G. Schmidt, Compliance Officer. If you have any questions about the contents of this letter, please contact Ms. Schmidt by phone at 303-236-3046 or via email at email@example.com.
LaTonya M. Mitchell
Denver District Director
This page was posted on April 30, 2019.