Inspections, Compliance, Enforcement, and Criminal Investigations

Osea Internacional 9/27/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415
 

 

WARNING LETTER
                                                                                                                          
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 27, 2016
WL #50-16
Jenefer Palmer, Founder
Osea Internacional
30765 Pacific Coast Highway #205
Malibu, CA 90265
 
Dear Ms. Palmer,
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://oseamalibu.com/ in August 2016 and has determined that you take orders there for the products Blemish Balm, Essential Corrective Complex, Brightening Serum, and Sea Vitamin Boost. The claims on your website establish that the products are drugs under sections 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 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or 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:
 
Blemish Balm
  • “[H]ealing blend of Cypress, Juniper, and Rosemary essential oils, known for their antibacterial, antiseptic and anti-inflammatory properties.”
  • “Blemish Balm reduces inflammation…”
  • “A proprietary base of three seaweeds combined with a unique blend of Cypress, Juniper, and Rosemary essential oils…reduces inflammation, regulates sebum production, heals…”
  • “Rosemary [an ingredient in the product] helps strengthen the capillaries…It helps to prevent age-related skin damage by safeguarding a protective protein called HSP70. The role of this protein is to reduce damage to skin caused by stress, free radicals, and other toxins.”
  • “Saccharomyces/Copper Ferment [an ingredient in the product]…It has been shown to stimulate tissue-repair…”
  • “Saccharomyces Zinc Ferment [an ingredient in the product]…Saccharomyces/Zinc ferment peptide…promotes wound healing.” 
Essential Corrective Complex
  • “Contains Tea Tree, White Thyme and Juniper which all have powerful natural antiseptic and antibacterial properties.”
  • “How it Works: A naturally antibacterial, anti-fungal, and antiseptic complex to effectively treat blemishes, cold sores, insect bites and ingrown hairs.”
  • “Essential Oil of Tea Tree [an ingredient in the product] has antiseptic properties that make it a gentle method of controlling skin irritations and infections such as acne, cold sores, athlete's foot, insect bites and minor cuts, scrapes, and scratches.”
  • “White Thyme [an ingredient in the product] helps stimulate circulation and has powerful antiseptic, bactericidal and insecticidal properties.”
Brightening Serum
  • “How it Works: Bearberry Leaf is a natural skin lightener that works by actively inhibiting skin’s melanin production. It has been proven to be highly effective for lightening age spots, freckles, sun spots, Melasma…” 
Sea Vitamin Boost
  • “USDA Certified Organic Gigartina Algae bolsters immune response …It also has been found effective for skin ailments such as psoriasis, eczema, and herpes.”
  • “Pomegranate Extract has been shown to boost collagen production…”
  • “Red Wine Extract, loaded with resveratrol…contains anti-viral and anti-fungal properties.”
  •  “Wine Polyphenols Proline (Red Wine Extract) [an ingredient in the product]…stimulate the production of elastin and collagen cells…bioactive polyphenols…prolong cell life for a dual preventative and curative…action.” 
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. 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.
 
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.
 
Please send your written response to:
 
Kelly Sheppard
Director, Compliance Branch
Food & Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions about the contents of this letter, please contact Daniel W. Cline, Compliance Officer at 949-608-4433 or Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Director, Los Angeles District

 

Page Last Updated: 10/21/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English