Inspections, Compliance, Enforcement, and Criminal Investigations

Reviva Labs Inc 5/10/16

  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969

 

WARNING LETTER
 
 
May 10, 2016
 
 
VIA UNITED PARCEL SERVICE                                                             
16-NWJ-06
Stephen Strassler
President
Reviva labs, Inc.
705 Hopkins Road
Haddonfield, NJ 08033-3028
 
Dear Mr. Strassler:
 
During an inspection of your firm located in Haddonfield, New Jersey on October 23, 2015 through November 18, 2015, investigators from the United States Food and Drug Administration determined that your firm is a cosmetic re-packer and labeler, as well as a re-labeler of over-the-counter (OTC) drug products. You also distribute cosmetics and over-the-counter (OTC) drug products under your own label.
 
This is to advise you that FDA reviewed your cosmetic product labels following the inspection and your website at the internet address, www.revivalabs.com, in March 2016 and has determined that you take orders on your website for your cosmetic products, including Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream.  The claims on your product labels and website indicate establish that the Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream 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 § 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 any function of the human body, rendering them drugs under the Act. 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.
 
We received your written response dated November 20, 2015, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you at the conclusion of the inspection.
 
Unapproved New Drugs
 
Examples of some of the product label and website claims that provide evidence that your products are intended for use as drugs include:
 
Nasolabial Fold Multi-Peptide Cream
 
[Product Label]
  • “Our cream’s complex formula includes…ingredients that can help increase fatty tissue volume to…plum up…”
 
[Website]
  • “Special new peptides and additional ingredients can help increase the volume of fatty tissue.”
  • “[H]yaluronic acid can help…reduce inflammation…”
Glycolic Acid Oily Skin Daytime Light Cream Moisturizer
 
[Product Label]
  • “Reduces blemish-causing bacteria…”
 
[Website]
  • “Reduces blemish-causing bacteria…”
  •  [Glycolic acid-an ingredient in your product] “It is used…reduce hyperpigmentation, lessen sun damage...”
Skin Lightener For Day Fade Cream
 
[Product Label]
  • “Results for lightening age spots or discoloration like never before…”
  •  “[H]elping to fade dark spots…”
 [Website]
  • “Effective treatment for brown spots and other skin discolorations” 
DMAE Firming Fluid
 
[Website]
  • “DMAE uniquely stimulates muscle tone for firmer, tighter throat and facial areas.”
  • “Acetylcholine is one of the body's major elements responsible for muscle tone. DMAE is known to stimulate acetylcholine, thus helping aging skin achieve improved facial contours.”
  •  “DMAE’s firming effects are believed to involve the signaling of acetylcholine in the skin.” 
Collagen Regeneration Cream
 
[Website
  • “Stimulating your skin’s own collagen and aiding new collagen production is a different story — and the focus of this cream.”
  • “Its Palmitoyl Tripeptide-5 sends signals to dermal fibroblasts to synthesize new collagen (the peptide isn’t absorbed to reach fibroblasts; it acts like a messenger).”
  • “Coenzyme Q10 (CoQ10 or ubiquinone) has antioxidant and anti-inflammatory effects.”
  • “Coenzyme Q10 can help to stimluate healthy collagen production in the skin, fight free-radical damage (caused by UV exposure)…”
Lighten & Brighten Dark Spot Serum
 
[Website]
  • “Diminish dark spots…”
  • “Kojic acid …is used in cosmetics to lighten skin by inhibiting or interrupting the skin's production of melanin. The production of melanin is what determines skin pigmentation.”
  • “Kojic acid interferes with melanin production, helping to lighten the skin.”
  • “Kojic acid is also known for its…antibacterial, and antifungal properties.”
Spider Vein & Rosacea Day Cream W/Vitamin P
 
[Website]  
  • “Soy benefits the skin by providing antioxidant and anti-inflammatory protection. Studies have shown that a component of soy, known as genistein, has a collagen-stimulating effect. Other compounds found in soy have been linked to increased skin thickness and elasticity. Soy extracts are shown to produce amazing skin rejuvenating benefits externally as well as internally.” 
Vitamin K Cream
 
[Website
  • “This special Vitamin K formula helps fade and clear bruises.”
  • “Primarily to help fade and clear bruises, before or after surgery, black and blue marks, etc.”
  • “Also helps treat red, irritated areas on the face, spider veins and rosacea…” 
Your above-listed 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.  
 
In addition to the above violation, oOur inspection revealed insanitary practices that may lead to insanitary conditions that may cause your products to become contaminated with filth or rendered injurious to health. , we also have the following comment. Under Section 601(c) of the Act [21 U.S.C. 361(c)], a cosmetic is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
 
Specifically:
 
a.    We observed a box of vitamin E stick sleeves and bulk products (e.g. Organic Cleansing Milk, Spider Vein & Rosacea Day Cream, Under Eye Dark Circle Serum, High Potency Collagen Serum, Throat & Eye Cream, Alpha Lipoic Acid, Vitamin C Ester & DMAE Cream, Professional Strength Hyaluronic Acid Serum, and Elastin & DMAE Night Cream) in close proximity to rainwater entering into the warehouse through a broken bay door. 
 
We have reviewed your written response, dated November 20, 2015. However, we are unable to evaluate your response due to lack of supporting documentation.  
 
Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Please iinclude an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
Your firm’s response to this letter should be sent to: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054. Refer to Case #16-NWJ-06 when replying. If you have any questions about the contents of this letter, please contact Charles J. Chacko, Compliance Officer at 1-973-331-4946 (phone) or 1-973-331-4969 (fax).
  
 
Sincerely yours,
/S/
Craig Swanson
Acting District Director
New Jersey District

 

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