Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration

  Dallas District
4040 North Central Expressway
Dallas, Texas 75204ยท3128

September 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"

"Artemisinin"

"Leuko-Stim"

"Cellular Health (I3C) (Indole-3-Carbinol 200mg)"

"Chol-Less"

"GastroHealth"

"Omega 3"

"Selenium 200 mcg"

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

This page was posted on September 22, 2011.

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