Inspections, Compliance, Enforcement, and Criminal Investigations
Almased USA, Inc. 1/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 18, 2012
Mr. Andre Trouille
Almased USA, Inc.
2861 34th Street South
St. Petersburg, 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, 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)(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 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.
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)(B) 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 407-475-4731.
Emma R. Singleton
Director, Florida District