| Public Health Service Food and Drug Administration |
Dallas District |
Department of Health and Human ServicesSeptember 7, 2011
2011-DAL-WL-17
WARNING LETTER
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Robert S. Baurys II
Chairman and Chief Executive Officer
Chronicity Inc.
www.chronicityinc.com
16415 Addison Road Suite 600
Addison, Texas 75001
Dear Mr. Baurys:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at www.chronicityinc.com in August 2011 and has determined that your “Anti-Viral,” “Artemisinin,” “Cellular Health,” ”Chol-Less,” “GastroHealth,” “Leuko-Stim,” “Omega 3,” and “Selenium” 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 therapeutic 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. You can find the Act and related regulations through links on FDA’s home page at www.fda.gov.
Examples of claims on your website include the following:
From the homepage, the link “Online Store” leads to a web page with the heading “OUR SUPPLEMENTS,” under which there is a list of supplements for various functions (e.g., Cardio Health, Cellular Energy Support, Digestive Support). This web page contains the following therapeutic claim:
“Our NutriElements supplements provide the nutritional support necessary to help relieve the specific symptoms associated with chronic conditions such as Fibromyalgia, Chronic Fatigue Syndrome, hormonal dysfunction, and fatigue-related conditions. As leading experts in the treatment of these conditions, we understand the nutritional components necessary to aid in recovery of vitality, energy and overall wellness utilizing supplements in your plan of care. Our store offers convenience and peace of mind knowing that our products are specifically designed to treat the symptoms associated with these life-altering conditions.”
Clicking on a specific function from this page opens to a web page that lists recommended products for that function.
“Anti –Viral”
• “Anti-Viral is designed to treat the chronic viral infections associated with chronic fatigue syndrome and fibromyalgia, including EBV, CMV and HHV-6. The components are designed to act synergistically against viral replication, viral binding to the host cellular membrane and shedding of the viral envelope that is required for replication and infection while other components disintegrate the viral envelope to make the virus more susceptible to host defenses while boosting the body’s immune system.”
“Artemisinin”
• “[A]rtemisinin can be used to treat small bowel bacterial overgrowth, Clostridial overgrowth and as a treatment for intestinal parasites.”
• “[Artemisinin] can be used in the treatment of certain cancers.”
• “[Artemisinin] can be helpful in eliminating necrotic material from the body; for example, from wounds from intestines of people who have ulcerative colitis, and Crohn’s disease.”
• “Artemisinin . . . [is] used to treat malaria, but is also very effective against other viral, bacterial and fungal infections.”
• “Research has also shown [Artemisinin] to be effective at destroying cancer cells in the body . . . .”
“Leuko-Stim”
• “[Leuko-Stim] improves the ability to fight infections and decreases cancer risk.”
“Cellular Health (I3C) (Indole-3-Carbinol 200mg)”
• “Recent studies have shown that Indole-3-carbinol significantly prevents breast, cervical and endometrial cancer in women and prevents prostate cancer in men.”
• “A 1997 study noted that I3C not only stopped 54-61% of human cancer cells form [sic] growing, but actually provoked the cells to self destruct.”
• ”[T]his powerful anti-breast cancer action has repeatedly been demonstrated in numerous studies.”
• “A study in 2000 showed that I3C caused complete regression of cervical cancer (CIN II-III) in 50% of these patients with this cancer.”
“Chol-Less”
• “Chol-Less . . . naturally reduce[s] cholesterol and triglyceride levels . . . .”
“GastroHealth”
• “GastroHealth . . . reduces the inflammation that is commonly seen with irritable bowl [sic] syndrome (IBS), leaky gut syndrome, food allergies, colitis, parasitic infections, inflammatory bowel diseases, Candida, chronic diarrhea and other GI conditions.”
“Omega 3”
• “Research has shown prevention of heart disease with the proper intake balance of these key ingredients [found in the product] . . . .”
• “[Omega 3] is used to reduce inflammation . . . reduce cholesterol and prevent heart disease and dementia.”
“Selenium 200 mcg”
• “[Selenium] deficiency . . . reduce[s] ability to break down peroxide and . . . increase[s] rate of thyroid cell necrosis and invasion of macrophages into an inflamed thyroid.”
• “[Selenium is] . . . shown to decrease TPO antibodys[sic] in individuals with autoimmune thyroiditis and to improve quality of life symptoms in these individuals as well as those with other autoimmune diseases.”
Your 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. The introduction of an unapproved new drug into interstate commerce is a violation of section 301(d) of the Act [21 U.S.C 331(d)].
Furthermore, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 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 above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that 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 and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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 violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Ms. Rose Ashley, Compliance Officer, U.S. Food and Drug Administration, San Antonio Resident Post, 10100 Reunion Place, Suite 100, San Antonio, TX 78216. If you have any questions regarding any issues in this letter, please contact Ms. Ashley at 210-541-9450 Ext. 118.
Sincerely,
/s/
Reynaldo Rodriguez, Jr.
Director
Dallas District Office
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