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

Public Health Service
Food and Drug Administration
  555 Winderley PI., Ste. 200
Maitland, Fl 32751

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 22, 2008

Todd Weardon, President
Aaron Weardon, Vice President
Health Center for Better Living, Inc.
1414 Rosemary Lane
Naples, Florida 34103

WARNING LETTER
FLA-08-26

Dear Mr. Todd Weardon and Mr. Aaron Weardon:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.hcbl.com and has determined that the products .. "Green Tea Capsules," "Lycopene," "Melatonin," "Omega 3-6-9," "Omega 3," `Prostate Support," "Selenium" and "Turneric" [sic] 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 the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Green Tea Capsules

Lycopene

Melatonin

Omega 3-6-9

Omega 3

Prostate Support

Examples of some of the claims your website makes in describing ingredients in this product include:

Selenium

Tumeric [sic]

The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include: "anti-inflammatory," "prostate cancer supplement," "joint pain," and "arthritis pain."

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. Your products "Green Tea Capsules," "Lycopene," "Melatonin," "Omega 3-6-9," "Omega 3," "Prostate Support," "Selenium" and "Turmeric" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(0(1)].

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 Shari H . Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District

This page was posted on July 19, 2010.

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