| Public Health Service Food and Drug Administration |
San Juan District |
Department of Health and Human ServicesMay 2, 2011
WARNING LETTER
11-SJN-WL-09
VIA OVERNIGHT MAIL
Mr. Jose Lazzof
President
Le Natural, Inc. and 9-12 Corp.
PMB Dept 388
HC-O1 Box 29030
Caguas, PR 00725
Dear Mr. Lazzof:
The United States Food and Drug Administration (FDA) reviewed the labels for your Elevate enhanced fiber water (lemon and orange flavor) products. We examined the product labels and your website at www.elevatewaters.net in April of 2011. Based on our review, we have
determined that your Elevate enhanced fiber water (lemon and orange flavor) products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 343]. We also determined that your products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of 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 these products with these claims violates the Act. You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov.
Unapproved New Drug
We have determined that your website www.elevatewaters.net is labeling for your Elevate enhanced fiber water (lemon and orange flavor) products under section 201(m) of the Act [21 U.S.C. § 321(m)) because the website address appears on the labels of these products. The
following is an example of a claim observed on your website:
• "Helps manage diabetes."
Your products are not generally recognized as safe and effective for the above referenced condition and therefore, the products are "new drugs" as defined under section 201(p) of the Act [21 U.S.c. § 321(p)]. New drugs may not be legally marketed in the United States 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.
Misbranded Food
Your Elevate enhanced fiber water (lemon and orange flavor) products are misbranded within the meaning of section 403(r)(1)(B) of the Act [21 US.C. § 343(r)(1)(B)] because the labeling for these products bears unauthorized health claims. Your website bears the following
unauthorized health claims:
• "A diet rich in fiber can reduce the risk of cardiovascular disease, obesity, an (sic) high blood pressure."
• "The direct benefits of fiber. .. Helps to reduce the risk of cancer."
These health claims misbrand your products because they have not been authorized either by regulation (see section 403(r)(3)(A)-(B) of the Act [21 US.C. § 343(r)(3)(A)-(B)]) or under authority of the health claim notification provision of the Act (see section 403(r)(3)(C) of the Act
[21 US.C. § 343(r)(3)(C)]). Further, although FDA has issued a regulation authorizing a health claim associating fiber with a reduced risk of cancer (21 CFR 101.76), the claim on your website that states "The direct benefits of fiber. .. Helps to reduce the risk of cancer" does not meet the requirements for this claim. For example, under 21 CFR 101.76(c)(2)(C) the claim is limited to grain products, fruits, and vegetables that contain dietary fiber. Your products do not fall under any of these categories, and therefore do no meet the requirements to make this claim.
Your Elevate enhanced fiber water (lemon and orange flavor) products are also misbranded under Section 403(i)(1) of the Act [21 US.c. § 343)(i)(1)] because the products fail to bear an adequate common or usual name of the food as specified by 21 CFR 101.3(b)(2). Specifically,
the labels for your products bear the name "Enhanced Fiber Water." Given that your products are sweetened with sugar and water is a substance that is free of calories and sweeteners, identifying this beverage as an orange or lemon flavored fiber water does not appropriately
describe the product as required under 21 CFR 101.3(b)(3).
This letter is not meant to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations
described above. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction [21 US.C. §§ 332 and 334].
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and to ensure similar violations do not occur. You should include in your response documentation such as copies of new labels, or other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, you should explain the reason for your delay and the time frame within which any remaining violations will be completed.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issues in this letter, please
contact Mr. Nevarez at (787) 474-9545.
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District Office
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