Inspections, Compliance, Enforcement, and Criminal Investigations
LifeGuard Health LLC 29-Jul-08
Department of Health and Human Services
Public Health Service
College Park, MD 20740
JUL 29 2008
RETURN RECEIPT REQUESTED
Kenneth A. Krieg
LifeGuard Health, LLC
502 West Germantown Pike, Suite 750
Plymouth Meeting, Pennsylvania 19462
Ref. No. CFSAN-OC-WL08-05
Dear Mr. Krieg:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.lifeguardforlife.com and has determined that the products Cardio Omega Benefits, Flex Omega Benefits, and Kid's Omega Advantage are promoted for conditions that cause the products to be drugs 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 establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
Cardio Omega Benefits
• "Cardio Omega Benefits is the perfect choice for people concerned about:
High Cholesterol . . ."
• "Randomized clinical trials have shown that Omega-3 essential fatty acid (EFA) supplements can reduce cardiovascular events such as heart attacks, stroke and even death."
• The promotion of "Cardio Omega Benefits" under the following "specific coticem" categories cause this product to be a drug because these categories refer to diseases as defined in 21 CFR 101.93(g)(1): "Diabetes," "Cardiovascular Disease," and "High Cholesterol."
• "Diabetes affects an increasing number of people throughout the world. Poor diet and obesity are major contributing factors to the increasing incidence of this disease. Studies suggest that the daily intake of Omega 3 fatty acids may be beneficial for diabetics:
-By helping to avoid heart disease, consumption of Omega 3s can mitigate a major risk factor associated with diabetes.
-Insulin resistance may be improved through consumption of Omega 3s."
• "The Omega Cardio and Omega Flex products are most frequently used by individuals with diabetes."
• "Studies have shown that at least 2.7 grams of Omega-3s are needed for anti-inflammatory effects[.]" [reference omitted]
Flex Omega Benefits
• The promotion of "Flex Omega Benefits" under the following "specific concern" categories cause this product to be a drug because these categories refer to diseases as defined in 21 CFR 101.93(g)(1): "Rheumatoid Arthritis," "Fibromyalgia," "Back, Neck & Joint Pain," "Arthritis," "Psoriasis," "Osteoarthritis," "Irritable Bowel Syndrome," "Alzheimer Disease," and "Lupus."
• Examples of claims about this product observed on your website under "Alzheimer Disease" Include:
- "Millions of people suffer from the debilitating effects of Alzheimer disease. A recent study suggest [sic] that those in the very earliest stages of Alzheimer disease may benefit from the consumption of Omega-3 essential fatty acids (EFA)."
- "Known as the "brain food" omega-3, DHA has been studied for its impact on reducing . . . early onset Alzheimer's disease and dementia."
• "Millions of people are searching for relief from aches, pains and inflammation. The dangers of COX-2 inhibitors are widely known. Recent medical research suggests use of non-steroidal anti inflammatory drugs (NSAIDS) have many safety issues.
Inflammation is the underlying cause for most pain. Omega 3 essential fatty acids have been clinically shown to have significant anti-inflammatory and pain relieving properties."
• "Flex Omega Benefits is a must for people who suffer from:
Back, Neck & Joint Pain
Irritable Bowel Syndrome
Kid's Omega Advantage
• "Critical in preventing and managing childhood diseases such as asthma, eczema as well as allergies and behavioral mood disorders such as ADD and ADHD."
• "Medical research clearly demonstrates the benefit of Omega-3 supplementation for children. Documented benefits include . . . a decreased incidence of allergies and asthma and a reduction of the symptoms of ADD and ADHD!"
• "Because of the predominance of Omega 6 fatty acids in our western diet, most
children are not in Omega Balance, a condition that produces chronic inflammation. . ."
Your website also contains disease claims in the form of personal testimonials, including:
• "I am so impressed with the positive impact that your Omega 3 products have had on my practice and my patients. We have had incredible results over the past 5 months ranging from lowering blood pressure, relief of chronic arthritic pain, skin conditions such as eczema, psoriasis . . . . I would also like to share a wonderful result from my patient Maryann. I prescribed 4 grams/day of your Omega Cardio brand 3 months ago. We recently retested Maryann and her total cholesterol went from 329 to 205. Her LDL's [sic] which are the bad cholesterol went from 236 to 120. These are amazing results and I am so proud to continue to use your full line of Omega 3 products."
Dr. Steve Karp, West Chester, PA
Further, your website cites publications about the use of omega-3 fatty acids for treatment of arthritis and Alzheimer's disease. When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following are examples of reference citations used to market your products for disease treatment on your website:
• Cleland L, James M, Provman S: fish oil: What the prescriber needs to know. Arthritis Res Therapy 2005 Dec 21; 8(1):Zu2
• Yvonne Freund-Levi, M.D., Maria Eriksdotter-Jonhagen, M.D., Ph.D., Tommy Cederholm, M.D., Ph.D., et al: "Omega-3 Fatty Acid Treatment in 174 Patients With Mild to Moderate Alzheimer Disease: OmegAD Study." Archives of Neurology: Volume 63, October 2006, pages 1402-1408.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. §321(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.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all FDA regulated products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, 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.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Quyen T. Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835
Office of Compliance
Center for Food Safety
and Applied Nutrition