FDA action

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Almased USA, Inc. 1/18/12

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

Services

Public Health Service

Food and Drug Administration

Florida District

555 Winderley Place, Suite 200

Maitland, Florida 32751

Telephone:

FAX:

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-21

January 18, 2012

Mr. Andre Trouille

Almased USA, Inc.

2861 34th Street South

St. sburg, FL 33711

Dear Mr. Trouille:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed

your website at www.almased.com<http://www.almased.com>, and " The Weight Loss

Program " booklet, in January 2012 and has determined that your " Almased® "

product, which the labeling indicates is a dietary supplement, is promoted for

conditions that cause the product to be a drug under section 201(g)(1)( of the

Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(]. The

therapeutic claims on your website and in your booklet 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 your product with these

claims violates the Act. You can find the Act and FDA's regulations through

links on FDA's home page at

http://www.fda.gov<http://www.mynewsletterbuilder.com/tools/refer.php?s=53986717\

11 & u=25637165 & v=3 & key=5c88 & skey=74ab423142 & url=http%3A%2F%2Fwww.fda.gov%2F>.

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

On your webpage titled " Company Background " :

* " [T]he International Journal of Obesity reported the beneficial effects of

Almased® on ... obese individuals. Research has also revealed that Almased® can

be extremely helpful for people with diabetes .... "

On your webpage titled " How Almased® can help People with Diabetes " :

* " The participants in the study used 50 g Almased daily as part of their diet.

The result: ... their blood levels-especially the fasting blood sugar level, the

fasting insulin level and the long-term blood sugar level-improved noticeably. "

* " Recent studies have shown that an Almased-supported diet significantly lowers

insulin level as well as the HbA1c level, which measure the blood sugar level of

approximately the past 4 weeks. "

On your webpage titled " FAQ " :

* " Besides stabilizing blood sugar and insulin levels, Almased has also been

shown to reduce blood pressure and cholesterol levels if they were elevated

before. "

On your webpage titled " What Scientists Say About Almased " :

* " Almased actively fights ... high blood pressure and insulin resistance ... "

* " Almased fights ... high blood pressure, cholesterol and diabetes. "

* " Obesity is associated with a severely increased leptin level, which in turn

is linked with insulin resistance and considered a cause of. .. diabetes.

Almased lowers the leptin levels, thus influencing risk factors favorably. "

* " Improved Blood Levels for People with Diabetes. 50 g of Almased per day

considerably improves blood levels (e.g., blood sugar,HbA1c value) in people

with diabetes. "

* " Reduced LDL Cholesterol Level. A weight loss program induced by Almased

lowers LDL cholesterol and triglyceride levels while raising HDL cholesterol

levels. "

* " Reduced Blood Pressure. A weight loss program using Almased lowers systolic

and diastolic blood pressure. "

In addition, FDA picked up " The Weight Loss Program " booklet at your booth at

the 2011 Natural Products Expo East trade show that was held on September 22-24,

2011 at the Baltimore Convention Center. Examples of some of the claims in your

booklet include:

* p.8: " Almased® leads to a lower blood sugar level .... "

* p.10: " Almased® has a positive effect on important blood levels, including

cholesterol and blood sugar .... It ... is a good supplement for anybody,

including people with diabetes .... "

* p.12: " Almased® actively fights ... high blood pressure and insulin resistance

..... Almased fights high blood pressure, cholesterol and diabetes. "

* p.22: " Almased® can help people with diabetes .... [T]he fasting blood sugar

level, the fasting insulin level and the long-term blood sugar level- improved

noticeably (see chart on [p.23]). "

* Chart on p.23 titled: " Surprising success with diabetes mellitus "

* Inside back cover: " Balances insulin and blood sugar levels "

Furthermore, your website and " The Weight Loss Program " booklet on p.21, include

claims in the form of personal testimonials that establish the intended use of

your product as a drug. Examples of these testimonials include:

* " I've had diabetes for six years .... [M]y glucose level was 265. My

cholesterol and triglycerides were both high. My doctor wanted me to take

cholesterol medication but I turned to Almased® instead. Two years later ... my

cholesterol and triglycerides are in normal range and my fasting blood sugar is

now in normal range as well (99-104). "

* " One of my friends, who also has diabetes like me, began using Almased® ....

Now he is no longer on his diabetes mediation. This product really works .... "

The claims indicate that the Almased® product is intended for use in the cure,

mitigation, treatment, or prevention of disease. Based on these claims, such

product is a drug within the meaning of section 201(g)(1)( of the Act.

Furthermore, these claims are supplemented by the metatags you use to bring

consumers to your website. These metatags include " blood sugar level control " ,

" regulate blood sugar " , " help to regulate blood sugar levels " and " avoid insulin

spikes. "

Your Almased® product is not generally recognized as safe and effective for the

above referenced uses and, therefore, the product is a " new drug " under section

201(p) of the Act [21 U.S.C. § 32l(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.

Furthermore, your product is offered for conditions that are not amenable to

self-diagnosis and treatment by individuals who are not medical practitioners;

therefore, adequate directions for use cannot be written so that a layperson can

use this drug safely for its intended purpose. Thus, your product is misbranded

within the meaning of section 502(t)(1) of the Act [21 U.S.C. § 352(t)(1)], in

that the labeling fails to bear adequate directions for use. 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 violations

that exist in connection with your products and their labeling. It is your

responsibility to ensure that all of your products and labeling are in

compliance with the laws and regulations enforced by FDA. You should take prompt

action to correct the violations described above and prevent their future

recurrence. Failure to promptly correct these violations may result in

regulatory action without further notice, such as seizure and injunction.

Please notify this office in writing within fifteen (15) working days from your

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. Your

response should include any documentation necessary to show that correction has

been achieved. If you cannot complete all corrections within fifteen days,

please explain the reason for the delay and state the date by which the

corrections will be completed.

Please send your reply to the attention of Mr. Winston R. Alejo, Compliance

Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland,

FL 32751. If you have any questions regarding any issue in this letter, please

contact Mr. Alejo at .

Sincerely,

/s/

Emma R. Singleton

Director, Florida District

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com<www.mraclinicalresearch.com/>

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