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Public Health Service |
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Office of Compliance |
Department of Health and Human Services
October 12, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Hale Wai Ola, LLC
PO Box 11032
Lahaina, HI 96761
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.halewaiola.com and has determined that the product Wai Ola is promoted for conditions that cause this product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your website include:
- "Wai Ola lowers blood sugar naturally."
- "Designed for the diabetic, Wai Ola Also [sic] supplies an important foundation for … hepatitis, high blood pressure, obesity. … The diabetic is seeing tremendous results from using Wai Ola."
- "There have been some side effects reported to us that we are happy to share. These are lowering of the blood pressure, … relief from some arthritis. We do have one customer who claims to have stopped the advancement of his Lou Gerhig's [sic] disease by using Wai Ola."
- "There is so much satisfaction for us when we hear how Wai Ola is helping someone control their diabetes. Our most rewarding call come [sic] from a single mom in Philadelphia. She told us she had not been able to take her diabetes medicine for a while because she could not afford it. … She called to say thank you for making a product that worked and she could afford."
Examples of some of the claims observed on your website in the form of a testimonial include:
- "My friends told me about Wai Ola. I have been able to lower insulin injections from 2 times per day to 1 time daily. 90 units down to 35 units per day. In a span of 4 months."
- "Diabetes for 8 years. I have been able to discontinue taking 2000 milligrams of Glucophag [sic] and 12 milligrams of glynaze [sic] per day because of your product. I had been very concerned about the effects of prescription drugs and am so happy to be able to take a natural product with no side effects and the same results."
- "A friend gave me a bottle of Wai Ola capsules to take to lower my blood sugar (type 2 diabetes). Previous Blood glucose would range around 300 (mg/dL) in the mornings. It's been about 3 weeks since taking the capsules with my blood glucose now averaging 130 to 140 (mg/dL). Currently taking medication Glyburide along with Wai Ola. My goal is to get off of drug medication if possible."
- "I've been taking the Wai Ola now for 3 months and have had great blood pressure readings. I no longer have to use my two prescribed medications with side affects [sic]. I just use Wai Ola and feel great no side affects [sic]. My Dr. was wondering why I don't call for refills and noticed my readings were great so he doesn't see me as often.
Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions, and, therefore, the product is also a "new drug" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 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.
This product is also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(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 promoted other products for disease treatment and/or prevention. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. While reviewing your website, we urge 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.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be addressed to Kristen Moe, Compliance Officer, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Compliance and Enforcement (HFS-607), 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you prefer to respond electronically, send your e-mail to kristen.moe@fda.hhs.gov If you have any questions concerning this letter, please contact Ms Moe at 301-436-2064.
Sincerely,
/s/
Joseph R. Baca
Office Director
This page was posted on February 12, 2008.