Inspections, Compliance, Enforcement, and Criminal Investigations
Health Center for Better Living, Inc. 22-Aug-08
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
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
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
• "Are you aware of the positive effects that Green Tea can have on preventing cancer? Green Tea contains polyphenols, which is a powerful antioxidant that can help kill cancerous cells in the body. This supplement has been known to prohibit the growth of breast cancer cells. This supplement?s [sic] anti-inflammatory and anti-cancer characteristics can also assist with skin cancer, even after it is established and during the growth of skin tumors. Research has shown the benefits of using Green Tea to lower cholesterol. This supplement can help to reduce damage caused by LDL (bad) cholesterol."
• "GREEN TEA : ... helps lower cholesterol levels. Helpful for ... stabilizing blood sugar and insulin levels, and protecting the body against cancer ...
• "Lycopene ... has such powerful capabilities in fighting off free radically-generated cancers."
• "Lycopene has also been found beneficial in assisting Prostate Cancer by reducing the size of the tumors."
• "Lycopene has also shown to aid with Cardiovascular Disease. This supplement has shown beneficial in lowering high levels of LDL degeneration within the tissue. By lowering the LDL (bad) cholesterol, it can help reduce one?s [sic] chances of getting a heart attack. Also, Lycopene has been found to aid those who suffer from Hypertension by reducing high blood pressure."
• "Especially useful for lowering the risk of prostate cancer and cardiovascular disease."
• "Research has shown that this supplement can aid those who ... suffer from insomnia by playing a role in inducing sleep."
• "Research has shown that those who have low levels of Melatonin have a greater chance of getting breast cancer and prostate cancer. By adding this supplement to your daily diet, your body has a better chance of fighting off the growth of certain types of cancer cells. Furthermore, Melatonin can help those who already have cancer by reducing the side effects of radiation."
• "Omega 3-6-9 can even help protect against cancer, heart disease, and cataracts."
• "Omega 3-6-9 can assist with Attention Deficit Hyperactivity Disorder (ADHD) ..... Research has shown that Omega 3-6-9 can be beneficial to those who suffer from Rheumatoid Arthritis ... This supplement can also reduce your changes of high blood pressure as well as heart disease .... Studies have shown that Omega 3-6-9 can assist with the body?s [sic] natural fight against cancer. The GLA and EPO which are found in this supplement can help combat colon and breast cancer."
• "Taking Omega 3 decreases the risk of heart disease. Omega 3 can also be used as an anti-inflammatory to relieve pain around the joints. Are you aware that by taking Omega 3 you can lower your cholesterol?"
• "Omega 3 has also been shown to help prevent cancer. Omega-3 has anti-cancer agents that help the body fight off certain kinds of cancer such as Colon, Breast, and Prostate Cancer. Also, this supplement has shown to be beneficial for individuals who are undergoing chemotherapy. Omega 3 has been shown to enhance the positive effects of chemotherapy and decrease negative ones. Research on Omega 3 has also shown positive results associated with Arthritis."
• "Protect yourself from prostate cancer with our superior blend."
• "Did you know that one in eight male cancer deaths are blamed on the prostate? Prevent yourself from being among this grave statistic by protecting your prostate now. While Prostate Support cannot cure cancer, it can help prevent it by supporting and enhancing your prostate gland with vital nutrients."
• "Examples of some of the claims your website makes in describing ingredients in this product include:
o "Kudzu is rich in isoflvones [sic] and is beneficial for ... preventing cancer."
o "Lycopene: Especially useful for lowering the risk of prostate cancer and cardiovascular disease."
• "Did you know that Selenium is a powerful antioxidant that can help prevent cancer? Selenium has been found to helpful [sic] in ... fighting off certain harmful bacteria and viruses. Cancer patients have low levels of Selenium, which is directly linked to the product of more tumors in the body. This supplement has been found to assist with healthy cell growth, which ultimately plays a factor in preventing tumors from producing in the first place. If a person has cancer, this supplement can aid with the prevention of the cancer from spreading to other parts of the body. Are you aware of the many benefits that Selenium can provide to the body to help prevent a heart attack or stroke? Selenium helps ... reduce the risk of your blood clotting, which can cause a heart attack. Along similar lines, Selenium has also been found to increase the HDL (good) cholesterol and decrease LDL (bad) cholesterol. Research has shown that Selenium can assist in the prevention of cataracts and macular degeneration ...."
• "This well known spice offers many benefits for Arthritis sufferers."
• "Tumeric [sic] has an anti-inflammatory agents [sic], which can be helpful with such ailments as carpal tunnel syndrome, arthritis, and joint inflammation."
• "New research has shown that Tumeric [sic] can help treat certain types of cancer."
• "[H]elps to prevent certain types of cancer from forming and producing, such as Breast, Skin, and Colon cancer."
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.
Emma R. Singleton
Director, Florida District