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:
                                                                       
Examples of some of the claims observed on your website www.1-fibromyalgia.com on webpages titled, “Chronic Fatigue Treatment”:
 
 
Examples of some of the claims observed on your website www.1-fibromyalgia.com regarding Iodine Plus2 include the following:
 
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:
 
 
Examples of some of the claims observed on your website www.1-vitamind.com regarding D5000 include the following:
 
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).”
 
 
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
 
For the website, www.1-ibs-irritablebowelsyndrome.com:
 
For the website, www.1-thyroid.com:
 
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

This page was posted on December 28, 2016.

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