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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Women's Health Institute of Texas 11/5/12

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

November 5, 2012
 
2013-DAL-WL-11
                                                                                                                       
WARNING LETTER
 
 
UPS OVERNIGHT MAIL
 
Andrew Jones, MD
The Women’s Health Institute at Texas
4771 Sweetwater Blvd., Suite 155
Sugar Land, TX 77479-3121
 
Dear Dr. Jones:
                                                                             
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites in September 2012 at the following addresses: www.1-ibs-irritablebowelsyndrome.com, www.1-fibromyalgia.com, www.1-thyroid.com, www.1-vitamind.com and has determined that your Digest + SEB, Iodine Plus 2, and D5000 (Vitamin D) products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. 
 
Examples of some of the claims observed on your websites www.1-ibs-irritablebowelsyndrome.com and www.1-fibromyalgia.com regarding Digest + SEB include the following:
                                                                       
  •   “First line treatment for Irritable Bowel Syndrome.”
  •   “First line treatment for Leaky Gut Syndrome.”
  •   “New front-line recommendation for auto-immune diseases.”
Examples of some of the claims observed on your website www.1-fibromyalgia.com on webpages titled, “Chronic Fatigue Treatment”:
 
  •   “We Can Now Treat, Reverse…Even eliminate your most troubling Fibromyalgia symptoms … Protease + NK & Digest-SEB … Putting It All Together … treating and conquering your Fibromyalgia misery and pain.”
 
Examples of some of the claims observed on your website www.1-fibromyalgia.com regarding Iodine Plus2 include the following:
 
  •   “Here’s a chart in helping you decide what’s best for you:
1. Mild hypothyroidism – suggest 1 tablet
2. Moderate hypothyroidism – suggest 2 tablets
3. Profound hypothyroidism – suggest 2 - 3 tablets
4. Severe hypothyroidism – suggest 2 - 4 tablets
5. Hypothyroidism so bad that blood tests may be abnormal – maximum 4 tablets”
 
Examples of some of the claims observed on your website: www.1-thyroid.com regarding Iodine Plus 2 include the following:
 
  •   “Iodine-Plus2 effective as a stand-alone in many thyroid-deficient conditions”
  •   “Combination iodine/iodide supplementation is now first-line therapy for thyroid-deficient conditions. Iodine-Plus alone may enable your thyroid gland to function normally without having to resort to prescription thyroid hormones.”
  •   For Low Thyroid Symptoms– “Take one tablet daily.”
  •   Thyroid Autoimmune Diseases – “Take 4 – 6 capsules daily (safely taken up to 150 mg/day (12 tablets).”
 
Examples of some of the claims observed on your website www.1-vitamind.com regarding D5000 include the following:
 
  •   ”Here’s just a sample of the serious health issues people face with chronic Vitamin D deficiency”:
o   “Cancers – increased risk and severity of 11 types of cancer, including melanomas. Vitamin D has been shown to make cancers cells lose their blood supply and thus ability to expand. It also strikingly inhibits cell growth, inducing what's called ‘cell apoptosis' (inability to divide) in breast cancer, prostate cancer and osteosarcoma.”
 
o   “Body Inflammation – such as lupus, rheumatoid arthritis and inflammatory bowel disease like Crohn's Disease and Ulcerative Colitis.”
 
o   “Heart Disease - increased risk of both heart attacks and strokes.”
 
o   “Pain Issues – everything from joint pains, back aches, headaches… even those fleeting phantom pains cropping up seemingly out of nowhere. Vitamin D was recently discovered to inhibit NF-kappaB (a major promoter of inflammation).”
 
  •   “[W]ithout adequate amounts of Vitamin D, you’ll be sicker and die younger ...”
  •  “Vitamin D is a potent inhibitor of tumor cell induced angiogenesis - (meaning that Vitamin D can make cancers cells lose their blood supply, limiting their ability to expand).”
  •   “Most cancer cells have increased number of Vitamin D receptors, so they may be plausibly more susceptible to Vitamin D deficiency effects.”
  •   “11 kinds of cancer are inversely correlated with Vitamin D deficiency. Meaning the less Vitamin D in the body, the more cancer is likely to develop.”
  •   “Vitamin D strikingly inhibits cell proliferation, and induces cell apoptosis (inability to divide) in breast cancer, prostate cancer and osteosarcoma.”
  •   “Influenza epidemics are inversely correlated with Vitamin D deficiency.”
  •   “[I]nflammation is the body’s reaction to stress or disease. Long term inflammation can lead to chronic diseases like lupus, rheumatoid arthritis, inflammatory bowel disease, chronic pain, muscle pain, heart disease, depression, dementia, and a wide range of cancers, including skin melanomas.”
  •   “The correlation between Vitamin D deficiency, inflammation and heart failure was confirmed as recently as Jan 5, 2008 in the Journal of American Geriatric Society.”
 
Furthermore, the disease claims quoted above are supplemented by the use of metatags you use to bring consumers to your website.
           
For the website, www.1-fibromyalgia.com
  •   “treatment fibromyalgia”
  •   “Fibromyalgia can be treated successfully, naturally, with a 5 step program that is more effective and safer than prescription drugs.”
  •   “fibromyalgia, protease, enzymes, fibromyalgia symptoms, FMS, treatment fibromyalgia.”
 
For the website, www.1-ibs-irritablebowelsyndrome.com:
  •   “Irritable bowel syndrome can be treated with natural digestion enzymes found in Digest +SEB.”
  •   “Irritable bowel syndrome, irritable bowel, …irritable bowel treatment ...”
 
For the website, www.1-thyroid.com:
  •   “[H]ypothyroidism”
 
Your Digest + SEB, Iodine Plus 2, and D5000 (Vitamin D) 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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, your Digest + SEB, Iodine Plus 2, and D5000 (Vitamin D) products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
Within fifteen (15) working days from your receipt of this letter, please respond in writing as to the specific steps you have taken to correct the violations cited above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, explain the reason for the delay and state the date by which the corrections will be completed.
 
Please send your reply to the attention of Jeff R. Wooley, Compliance Officer, Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions regarding any issue in this letter, please contact Jeff R. Wooley at (214) 253-5251.
 
           
Sincerely,                                                                 
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director