Inspections, Compliance, Enforcement, and Criminal Investigations

Life Extension Foundation Buyers Club, Inc. 2/1/17

 

  

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Florida District Office
555 Winderley Place, Suite 200
Maitland, Florida 32751

 

VIA UPS NEXT DAY AIR
RETURN RECEIPT REQUESTED
Warning Letter 17-07
 
February 01, 2017
Paul Gilner, President
Life Extension Foundation
Buyers Club, Inc.
3600 W Commercial Blvd
Fort Lauderdale, FL 33309
 
Dear Mr. Gilner:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.lifeextension.com in December 2016 and has determined that you take orders there for the Life Extension products.  The claims on your website establish that the products are drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United State Code (USC) 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 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:
 
On the webpage titled, “HEALTH PROTOCOLS”, under the disease, “Breast Cancer” you include a link to a page with information about breast cancer and include, “Life Extensions Suggestions” which lists products and directions for use as part of the protocol. For example, as treatments for Breast Cancer, you suggest the following Life Extension products which are for sale on your website:
 
Apigenin
Astragalus
Blueberry
Chrysin
Coffee
Cruciferous vegetable extract
Curcumin
CLA or CLA with guarana
Lightly caffeinated green tea extract
Lignans:
Melatonin
Pomegranate
“Powders”
Pterostilbene
Quercetin:
Se-methylselenocysteine
Sulforaphane
CoQ10
EPA/DHA
Vitamin D3
Water-soluble vitamin A
Vitamin E
Gamma tocopherol
Vitamin C
Gamma linolenic acid
Whey protein concentrate-isolate
Calcium
Magnesium
Vitamin K
Silicon
Multinutrient formula
 
Your website also includes similar protocols where you suggest Life Extension products as treatments for various serious diseases, including the following:
 
Adrenal Disorders
Alzheimer’s Disease
Amnesia
Amyotrophic Lateral Sclerosis
Anxiety
Arrhythmias
Arthritis
Asthma
Atherosclerosis and cardiovascular disease
Attention Deficit Hyperactivity Disorder
Autoimmune Diseases
Bacterial Infections
Bell's Palsy
Benign Prostatic Hyperplasia
Blood Clot Prevention
Blood Disorders - Anemia, Leukopenia, Thrombocytopenia
Brain Tumor - Cancer
Cachexia and Sarcopenia
Cataracts
Celiac Disease
Cervical Dysplasia
Chronic Fatigue Syndrome
Chronic Kidney Disease
Chronic Obstructive Pulmonary Disease
Cirrhosis
Colorectal Cancer
Depression
Diabetes
Diabetic Neuropathy
Diverticulosis and Diverticular Disease
Endometriosis
Epilepsy - Seizures
Erectile Dysfunction
Fibromyalgia
Gastroesophageal Reflux Disease - GERD
Glaucoma
Gout and Hyperuricemia
Hearing Loss and Tinnitus
Heart Failure
Hemochromatosis
Hepatitis B
Hepatitis C
Herpes and Shingles
High Blood Pressure
HIV/AIDS
Hypothyroidism
Inflammatory Bowel Disease
Influenza
Insomnia
Irritable Bowel Syndrome (IBS)
Kidney Stones
Leukemia
Liver Degenerative Disease
Lung Cancer
Lupus
Lymphoma
Macular Degeneration
Meningitis
Migraine
Multiple Sclerosis (MS)
Muscular Dystrophy
Myasthenia Gravis
Myofascial Syndrome
Non-Alcoholic Fatty Liver Disease
Obsessive-Compulsive Disorder
Osteoarthritis
Osteoporosis
Pain (Chronic)
Pancreatic Cancer
Parkinson’s Disease
Polycystic Ovary Syndrome (PCOS)
Polymyalgia Rheumatica
Prostate Cancer
Psoriasis
Raynaud’s Phenomenon
Retinopathy
Rheumatoid Arthritis
Scleroderma
Sjögren's Syndrome
Skin Cancer
Sleep Apnea
Stroke
Trauma/Wound Healing
Urinary Tract Infection (UTI)
Uterine (Endometrial) Cancer
Uterine Fibroids
Vertigo
 
We also noted claims made on your Facebook page, accessible at www.facebook.com/lifeextension:
  • In a July 15, 2016 post titled, “Can blindness be avoided? Check out this exciting study!” which highlights the use of Life Extension products to reduce the risk of macular degeneration and links to an article titled, “Study Proves Natural Ways to Avoid Blindness” in Life Extension Magazine, accessible at www.lifeextension.com/Magazine/2016/7/Huge-Study-Validates-Natural-Approach-to-Prevent-Blindness and includes links to product pages, MacuGuard® Ocular Support and MacuGuard® Ocular Support with Astaxanthin, and the health protocol, “Macular Degeneration” listed above, where your products can be purchased directly.
  • In a July 17, 2016 post titled, “Supplementing with CoQ10? Your heart will seriously thank you” which highlights the use of Life Extension products to prevent the progression of heart failure and links to an article titled, “Why CoQ10 is Key to Heart Health” in Life Extension Magazine, accessible at www.lifeextension.com/magazine/2014/4/coq10-proven-benefits-in-heart-failure-patients and includes links to product pages to several Life Extension CoQ10 products and the health protocol, “Heart Failure” listed above, where your products can be purchased directly. 
Additionally, you offer for sale the e-book, Disease Prevention and Treatment, 5th Edition, authored by Life Extension Foundation, on your website. This book includes the protocols highlighted above found on your website and includes links to www.lef.org for updated protocols and more information. The website, www.lef.org automatically redirects to www.lifeextension.com where your products can be purchased directly. An example of the claims found in the book include from Chapter 25, “Brain Tumor”:
 
Under the subheading, “SUMMARY”:
  • “Given the inadequacy of standard medical treatment in controlling high-grade malignant brain tumors, this approach of co-treating brain tumors with brain tumor-specific diet and nutritional supplementation, in addition to the medical oncology standard of care, is an option that offers hope to those afflicted with brain tumors.” 
Further in the chapter, there is a link titled, “Life Extension Suggestions” which links to www.lifeextension.com. The book lists various products, as well as two different links – one for further references and another to read the “…[M]ost current version of this protocol” on www.lifeextension.com, where your products can be purchased directly.
 
Your Apigenin, Astragalus, Blueberry, Chrysin, and Cruciferous vegetable extract products, as well as many others, 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 USC 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 USC 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 USC 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 USC 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Furthermore, your Apigenin, Astragalus, Blueberry, Chrysin, and Cruciferous vegetable extract products, as well as many others, are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Apigenin, Astragalus, Blueberry, Chrysin, and Cruciferous vegetable extract products, as well as many others, fail to bear adequate directions for their intended uses and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
The 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 ensure 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.
 
We note that there are over 400 products on your website that contain various disease claims. You should review your website for violations not mentioned in this letter.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations noted above.  Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete corrective action within 15 working days, please explain the reason for the delay and the date by which each such item will be corrected.  
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. Your written response should be sent to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200 Maitland, FL 32751. If your have questions regarding any issues in this letter, please contact Mr. Morris at (407) 475-4741
 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District

 

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