January 31, 2012
MAITLAND, Fla.As companies get ready for the trade show season, they need to make sure all product literature is checked twice by their legal experts, as a recent warning letter shows FDA has no qualms about issuing warning letters based on materials picked up at a booth.
FDA recently warned Almased USA Inc. that booklets handed out an the 2011 Natural Products Expo East trade show, held Sept. 22 to 24, contained drug claims for the company's "Almased®" supplement. FDA said it 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 [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment or prevention of disease.
The letter said FDA picked up "The Weight Loss Program" booklet at the company booth and found such claims among its pages:
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"
Perhaps the booklet drew attention to the company's website as well. In the warning letter, FDA noted page 21 of the "The Weight Loss Program" booklet resembled illegal website claims in the form of personal testimonials. FDA has recently increased its warnings for unrestrained testimonials on webistes.
Examples of the testimonials on Almased's site included:
"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 .... "
FDA looked further into the website, Almased.com and found more problematic claims:
On the 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 the 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."
On the 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 the webpage titled "What Scientists Say About Almased": "Almased actively fights ... high blood pressure and insulin resistance ... ," "Almased fights ... high blood pressure, cholesterol and diabetes," and "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."
FDA also included metatags into the warning letter. The metatags, which are used to bring consumers to the website, included "blood sugar level control," "regulate blood sugar," "help to regulate blood sugar levels" and "avoid insulin spikes."
FDA gave the company 15 working days from the receipt of the letter to outline the specific steps it has taken to correct the violations and to assure similar violations do not occur.
You May Also Like