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WARNING LETTER

CV7 Holdings LLC MARCS-CMS 552109 —


Delivery Method:
Express Delivery

Recipient:
Recipient Name
Amanda Sotta
CV7 Holdings LLC

1818 SW 1st Street

Miami, FL 33129
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
 

WARNING LETTER

 

MAY 18 2018

VIA EXPRESS DELIVERY

 
Amanda Sotta, Manager
CV7 Holdings, LLC
1818 SW 1st Street
Miami, FL 33129
 
Re: 552109
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.soleilprotection.com in March 2018 and has determined that you take orders there for the product Soleil Sun Protection. In addition, FDA reviewed your product label after purchasing your product from your website. The claims on your website and product label establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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 Soleil Sun Protection product is intended for use as a drug include:
 
On your homepage:
·       “Add SOLEIL to your daily diet and have the best results EVER! A perfect water resistant sunblock with a mix of vitamins and antioxidants!”
·       “Think only sunscreen really protects you from sun damage? Well, think again!”
·       “We’ve spent years of research time finding the exact ingredients needed to help protect you from ultraviolet rays ….”
·       “How can you be sure that the carefully selected blend of ingredients in SOLEIL can really protect you from UVA and UVB rays and still prevent your premature aging?...[L]ook at what some research has revealed about the ingredients that make up SOLEIL’s formula…Article: Oral Extract Prevents UV-Induced DNA Skin Damage”
·       “Dr. Rafael Crippa – Dermatologist Specialist…Clinical research demonstrates that, taken orally prior to sun exposure, Polypodium leucotomos prevents DNA damage….”
·       “Certified skin protection from sun rays.”
 
On your Ingredients page:
·       “Polypodium leucotomos…Benefits of…[A]nti-inflammatory properties; Reduces UV-induced cell damage; Reduces oxidative stress and DNA damage; Blocks UV radiation-induced immune suppression.”
·       “Organic Carrot and Vitamin A (as beta-carotene)…helps in repairing the skin tissues and provides protection against the sun’s harsh rays…[C]ondition the skin to increase its immunity against the sun and heal sunburns…Benefits of…Fights Inflammation”
·       “Grape Seed and Resveratrol…taking grape seed extract substantially increased blood levels of antioxidants. Antioxidants…destroy free radicals, which…damage DNA (genetic material) and even cause cell death. Scientists believe free radicals contribute…heart disease and cancer. Benefits of...Antioxidant qualities protect from UV damage.”
·       “Lutein and Zeaxanthin…is associated with a lowered risk for age-related macular degeneration … prevention of light-exposed tissue, skin and eyes, from light-induced damage. Benefits of…Protects Against Eye Disorders”
·       “Vitamin D3…Benefits of…Reduces Diabetes Risk”
 
On your Benefits page:
·       “Avoid severe sunburn”
 
Examples of some of the product label claims that provide evidence that your Soleil Sun Protection product is intended for use as a drug include: 
  • “Sun protection”
  • “UV-defense”
  • “[H]elps to defend your body against the sun-related damage.”
·       “Soleil aids in preventing sun damage….”
 
Your Soleil Sun Protection product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Soleil Sun Protection product is intended for prevention of age related macular degeneration and diabetes, which are not amenable to prevention by consumers without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, the Soleil Sun Protection product fails to bear adequate directions for its intended uses and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
This letter is not an all-inclusive statement of violations associated with your product or its 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. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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 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.
 
You should direct your written reply to Beth Tirio, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Tirio via email at beth.tirio@fda.hhs.gov.
 
Sincerely,
/s/                                                           
William Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
US Food and Drug Administration
 
Cc: ORA/OHAFO 4E