Inspections, Compliance, Enforcement, and Criminal Investigations

Invitrx Therapeutics, Inc 2/27/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
February 27, 2017
WL# 17-17
Mr. Habib (nmi) Torfi, CEO
Invitrx Therapeutics, Inc.
27 Mauchly, Suite 200
Irvine, CA 92618
 
Dear Mr. Habib:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 27 Mauchly, Suite 200 Irvine, CA 92618 on September 12-26, 2016.  During the inspection, FDA collected product labels for your ReLuma Advanced Facial Moisturizer, ReLuma Women’s Hair, ReLuma Men’s Hair, Pserene Cream, and ReLuma Eye Crème products.  In addition, FDA reviewed your website at the Internet address, www.invitrx.com, in January 2017 and has determined that you take orders on your website for your products, including ReLuma Advanced Facial Moisturizer, ReLuma Women’s Hair, ReLuma Men’s Hair, Pserene Cream, and ReLuma Eye Crème. The claims on your product labels and website establish that your products are promoted for uses that cause the products to be 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 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. 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 the FDA’s home page at www.fda.gov.
 
Examples of some of the product labeling and website claims that provide evidence that your products are intended for use as drugs include:
 
ReLuma Advanced Facial Moisturizer
 
Website
  • “Human Adipose Derived Stem Cell Media: provides a therapeutic application of growth factors, and cytokines secreted from Human Adult Stem Cells…”
  • “With TGF-b (transforming growth factor-beta) to stimulate fibroblast cell growth, in the presence of PDGF (platelet derived growth factor) … it increases collagen, elastin and other matrix protein production to help prevent the effects and signs of aging.” 
ReLuma Women’s Hair & ReLuma Men’s Hair
 
Website
  • “Men and Women lose their hair as they age … ReLuma Hair is formulated to slow down the effects of aging on hair by helping to minimize hair thinning and loss, stimulating growth…”
  • “ReLuma Hair is formulated to alleviate androgenetic alopecia in two ways; with a mixture of cytokines and growth factors, and with Minoxidil.”
  • “Cytokines and growth factors…When applied to the scalp, ReLuma Hair will impart a strong “growth” signal that overshadows the “shrink” signal from DHT/TGF-beta, rescuing follicle cells from shrinking and impending cell death by reinvigorating them to a more youthful, active state.”
  • “Supplying a mixture of cytokines and growth factors in combination with increased blood flow creates an effective product that approaches hair loss from multiple modalities.”
Product insert
  • “Patent pending technology formulated with cytokines (TGF-b, PDFG, GM, CSG) interleukins, and matrix proteins. Helps reduce hair loss by replenishing the hair follicles natural growth factors, cytokines and proteins.”
  • “Side Effects: this medication may cause burning … if you notice other effects no listed above, contact your doctor or pharmacist.”
  • “Drug Interactions: before using Minoxidil, tell you doctor of any over the counter or prescription medications you are taking, especially of: guanethidine, other drugs used for high blood pressure. Do not start or stop any medicine without doctor or pharmacist approval.” 
Pserene Cream
 
Website
  •  “(Psoriasis Cream) Pserene is an intense skin moisturizer that prevents dehydration and other signs of premature aging to skin … some alleviate symptoms of severe dryness that are often associated with eczema and psoriasis, as well as very dry skin.”
  • “Human Adipose Derived Stem Cell Conditioned Media- provides a therapeutic application of growth factors and cytokines secreted from Human Adult Stem Cells…”
  • “With TFG-b (transforming growth factor- beta) to stimulate fibroblast cell growth, in the presence of PDGF (platelet derived growth factor) and excellent quantity of vitamins, amino acids, minerals, it increases collagen, elastin, and other matrix protein production to help improve texture, and thickness of skin.”
  • “Ascorbyl Palmltate- It is a potent antioxidant and free radical scavenger supporting cellular and vascular health. It supports the body’s defense system by enhancing white blood cell function and activity, and increasing interferon levels, antibody responses and secretion of thymic hormones.”
  • “Methylsulfonylmethane (MSM) – it is considered an anti-parasitic, anti-itching, blood vessel dilating, anti-oxidizing element when used cosmetically.”
  • “Bromelaln- can be used to treat a number of conditions, but it is particularly effective in reducing inflammation from infection and injuries.”
  • “Trolamlne NF- it is for the prevention of Radiation Dermatitis in Patients with Advanced Squamous Cell Carcinoma of the muscle soreness.” 
Reluma Eye Crème
 
Website
  • “The Natural Botox Effect. This relaxation of the muscle contractions around the eye occurs without muscle paralysis, allowing natural expression and movement in the target area while relaxing the muscle that is causing the wrinkle”
  • “The eye cream has a SPECIAL INGREDIENT which is a synthetic tetrapeptide with anti-edema properties specifically designed to reduce puffiness around the eyes.” 
Your ReLuma Advanced Facial Moisturizer, ReLuma Women’s Hair, ReLuma Men’s Hair, Pserene Cream, and ReLuma Eye Crème 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.
 
In addition to above violations, we offer the following comment. Our inspection revealed the following practices that may cause your products to be rendered injurious to health or to become contaminated with filth.
 
Specifically, during the inspection our investigators observed that adipose derived stem cells, dermal fibroblasts, and human cord blood, intended for use for research purposes, are used in the manufacturing of Human Adipose Derived Stem Cell Conditioned Media (HADSCM) for your ReLuma Advanced Facial Moisturizer, ReLuma Women’s Hair, ReLuma Men’s Hair, Pserene Cream, and ReLuma Eye Cream products.
 
We have concerns regarding the use of these adipose derived stem cells, dermal fibroblasts or human cord blood in the manufacture HADSCM to be used in your products because of the potential for viral or microbial contamination in the use of these materials. Based on our observations, we do not have any evidence that a validated viral inactivation/removal process or some other appropriate process is being used during the manufacturing process and the source of human cells used to manufacture the material is unknown. 
 
We acknowledge your response dated October 14, 2016, indicating that your firm intends to do the following: (1) discontinue the use of the cell lines, (2) purchase dermal fibroblasts cell line intended for commercial use, and (3) perform viral and microbial testing on harvested conditioned media. However, you fail to indicate how you will ensure the dermal fibroblast cell line will address our concerns. 
 
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 via e-mail to Daniel.Cline@fda.hhs.gov.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Director, Los Angeles District
 
 
cc:       
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435

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