Office of Human and Animal  Food - West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

 

VIA UPS RETURN RECEIPT
SIGNATURE REQUESTED
 
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:
 
Under Description
Lavish - Loving Recovery Beta-glucan Mask:
 
Under Description
Under Questions and Answers
Pure - Sensitive Skin Soothing Complex:
Under Description
Smooth A+ - Correcting Serum:
 
Under Description
Restore - Deep Healing Oil Serum:
 
Under Description
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  andrew.hoopes@fda.hhs.gov or 515-244-0480, ext. 1002.

Sincerely,
/S/
Ann M. Adams
District Director
Kansas City District Office

This page was posted on April 30, 2019.

Links to Recommended Companies

  • PharmacyChecker.com: Compare drug prices and save money at verified online pharmacies.
  • ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products.
  • Amazon.com: Discount prices, huge inventory, and superb customer service.
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.