Office of Human and Animal Food - West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
VIA UPS RETURN RECEIPT
July 6, 2017
Julie Longyear, Owner
Irie Star, LLC.
dba Blissoma Holistic Skincare and Apothecary
1418 N. Park Place
St. Louis, MO 63107
Reference: CMS # 524242
Dear Ms. Longyear:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.blissoma.com/ in May 2017 and has determined that you take orders there for the products Flawless - Equalizing Anti-Blemish Oil Serum, Lavish - Loving Recovery Beta-glucan Mask, Pure - Sensitive Skin Soothing Complex, Smooth A+ - Correcting Serum, Restore - Deep Healing Oil Serum. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § § 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or 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:
Flawless - Equalizing Anti-Blemish Oil Serum:
- “The result is a nutritious concoction rich in anti-inflammatory Omega fatty acids …”
- “Hemp [(an ingredient in your product)] … reduces redness and is recommended for the treatment of psoriasis and eczema.”
- “Organic Tamanu [(an ingredient in your product)] oil has proven antibacterial, anti- inflammatory and skin rebuilding properties …”
Lavish - Loving Recovery Beta-glucan Mask:
- “Beta glucans … are anti-inflammatory”
- “Organic oils of Baobab, Pomegranate, Perilla, and Pumpkin [(ingredients in your product)] make a synergy to soothe irritations whether they be from sun, wind, allergies, or chronic inflammatory conditions. Each of these oils is known to be helpful for eczema, dermatitis, chapping, and dryness.”
Under Questions and Answers
- “St. John's wort [(an ingredient in your product)] is anti-inflammatory and analgesic for skin irritations and damage.”
Pure - Sensitive Skin Soothing Complex:
- “100% natural, botanical recipe anti-redness and anti-inflammatory …”
- “Marshmallow [(an ingredient in your product)] provides soothing mucilage and Plantain leaf infuses reknowned anti-redness abilities. Self Heal comes packed with gentle but effective antimicrobial properties to keep acne and other skin disturbers at bay.”
- “Heather Flowers [(an ingredient in your product)] provide the anti-allergenic flavonoid Quercetin which also helps synthesize new collagen.”
Smooth A+ - Correcting Serum:
- “Cold-extracted Olive Leaf [(an ingredient in your product)] offers a fraction called Oleuropein known for its potent antibacterial and anti-inflammatory effects.”
- “Niacinamide [(an ingredient in your product)] is included at 4% which is a level proven in studies to be more effective than a 1% clindamycin antibacterial gel at preventing acne breakouts. It maintains ceramide levels …, synthesizes collagen, and evens coloration of the skin.”
Restore - Deep Healing Oil Serum:
- “Organic Evening Primrose oil and Pomegranate Oil [(ingredients in your product)] are rich in omega 5, 6, and 9 essential fatty acids including GLA which helps balance hormones, …”
- “Omega 5 is a rare fatty acid that acts as an… anti-inflammatory,…”
- “Pomegranate oil [(an ingredient in your product)] also has phytoestrogen to assist with hormone balancing, …”
- “Tamanu [(an ingredient in your product)] has been used … for its anti-inflammatory, antibacterial, and regenerative properties.”
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 that are promoted on your website for intended uses that cause them to be 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. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/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 Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration at 210 Walnut St., Suite 369, Des Moines, IA 50309. If you have any questions about the contents of this letter, please contact CO Hoopes at firstname.lastname@example.org or 515-244-0480, ext. 1002.
Ann M. Adams
Kansas City District Office
This page was posted on April 30, 2019.