Inspections, Compliance, Enforcement, and Criminal Investigations

Finally Pure, LLC 7/20/16

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 
Telephone:         425-302-0340
FAX:                    425-302-0402 

 

July 20, 2016
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED


In reply refer to Warning Letter SEA 16-15

Melanie Lindell & Nancy Tarr, Owners
Finally Pure, LLC
P.O. Box 876305
Wasilla, Alaska 99687

 
WARNING LETTER

Dear Ms. Lindell and Ms. Tarr:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.finallypure.com in May 2016 and has determined that you take orders there for the products Toner for All Skin Types, Unscented Day Cream for All Skin Types, Unscented Day Cream for Extra Sensitive Skin, Unscented Day Cream for Dry/Mature Skin, and Lemongrass Herbal Sore Muscle Massage Oil. 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:
 
Toner for All Skin Types 
  • “Antibacterial, antiviral, antifungal and antiparasitic”
  • “Organic Calendula: Soothing herb with many skin restorative benefits; antiseptic; aids in tissue regeneration by stimulating collagen production process, and helps in the formation of new blood vessels.”
  • “[A]nti-inflammatory”
  • “Helps to strengthen capillary walls”
  • “Organic Aloe Vera: . . . aids in the skin cell renewal process and collagen production . . . which helps to accelerate skin repair and reduce inflammation.”
  • “Organic Witch Hazel Hydrosol: . . . anti-inflammatory properties . . . reduce swelling.”
  • “Organic Chamomile (German): . . . antiseptic . . . anti-inflammatory properties; helps to strengthen capillaries . . . promote tissue regeneration”
 Unscented Day Cream for All Skin Types

  • “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
  • “Aloe Vera: Aids in stimulating the growth of new skin tissue, increasing circulation and drawing immune cells to the affected areas.”
  • “Aids in stimulating collagen production”
  • “Promotes skin repair and cell regeneration”
  • “[L]ightens dark or age spots”
  • “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Extra Sensitive Skin
  • “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assists in providing natural sun protection.”
  • “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
  • “Aids in the collagen production process”
  • “Hyaluronic Acid (Sodium Hyaluronate): . . . Its many functions include aiding in tissue repair . . . supporting collagen and elastin.”
Unscented Day Cream for Dry/Mature Skin
  • “The combined Organic ingredients of Red Raspberry Seed Oil (SPF 30-50), Carrot Seed Oil (SPF 30) and Shea Butter SPF 6-10) assist in providing natural sun protection.”
  • “The combination of these botanicals . . . stimulates . . . cell regeneration abilities.”
  • “Aids in stimulating collagen production”
  • “Hyaluronic Acid (Sodium Hyaluronate): Its many functions include aiding in tissue repair . . . supporting collagen and elastin.” 
Lemongrass Herbal Sore Muscle Massage Oil
  • “Organic Herb Arnica (Arnica Montana), which has been used for centuries to reduce inflammation and soothe sore muscles.”
  • “This natural vitamin E is known to . . . help skin to recover from scarring and other damage”

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.
 
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 U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. If you have any questions about the contents of this letter, please contact Ms. Arnold at 425-302-0437.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director

 

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