Department of Health and Human Services
Public Health Service
College Park, MD 20740
SEP 28 2007
RETURN RECEIPT REQUESTED
7007 Winchester Circle
Boulder, CO 80301
Re : CFSAN-OC-07-0 5
Dear Sir or Madam :
This is to advise you that the Food and Drug Administration (FDA) obtained a sample packet of your Efficas Care™ product and promotional literature entitled "efficas care™; for ALLERGIES and ASTHMA" at the American Society of Pharmacognosy (ASP) conference in Portland, Maine during the week of June 14, 2007. FDA has reviewed the labeling for Efficas Care on your website at http://www.efficas.com, as well as the label of the sample packet we collected. This review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its implementing regulations on FDA's website at http://www.fda.gov
Your product is labeled as a "medical food," and the labeling claims on the sample packet and on your website represent the product as a medical food for the dietary management of allergies and asthma. However, your product does not meet the definition of a medical food in 21 U.S.C. § 360ee(b)(3), which defines a medical food as a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Your product is not a medical food because, although allergies and asthma are diseases, neither has distinct nutritional requirements that are based on recognized scientific principles and established by medical evaluation.
Your product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the label is false or misleading in that the product is labeled as a medical food but does not meet the definition of a medical food.
Furthermore, the therapeutic claims in your labeling indicate that the product is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man. Similar claims and testimonials also appear on your website. Examples of these claims in your product labeling include the following:
•"efficas care for ALLERGIES and ASTHMA "
• "Efficas Care™ is clinically proven to reduce leukotrienes that cause allergy and asthma
• "More than 70% of sufferers report that Efficas Care™ relieves most or all of their allergy and asthma symptoms."
• "In clinical trials, when Efficas Care™ was added to a daily diet, the product of leukotrienes was suppressed in 75% of asthmatics."
• (testimonial) "Now after 8 months of taking Efficas Care™, I am completely free of asthma, off asthma medication ..."
• "Efficas Care is a non-prescription medical food developed to safely and naturally inhibit the body's production of leukotrienes. Efficas Care contains a unique combination of two essential fatty acids found in nature, GLA and EPA, in just the right amounts and ratio to effectively block the production of leukotrienes. Leukotrienes are inflammatory molecules produced by immune cells in your body. They are involved in the inflammatory response and cause the narrowing of the airways, increased mucus production and tissue swelling associated with both allergies and asthma."
• (testimonial) "I am eighteen years old and suffered from pollen allergies for most of my childhood, with severe congestion, watering eyes and frequent colds.I took weekly allergy shots for four years, with little relief. I was also on a daily regimen of Allegra, Singulair and Nasacort nose spray. I started taking Efficas Care this past summer, about 6 months ago. At first, the difference was subtle. .. but after a few months the improvement was dramatic! My symptoms are so minimal, I have entirely stopped all of my medications, and cut back my allergy shots to once a month. Even during the worst of the pollen season, I never need any medication. The only thing I have done to bring about this miraculous turn-around in my health is take Efficas Care daily."
These claims are evidence that your product is intended for use as a drug within the meaning of Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Your product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because this product is not generally recognized as safe and effective for its intended uses. 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)].
The above violations are not meant to be an all-inclusive list of deficiencies in your product and its labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributor of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Federal agencies are advised of the issuance of all Warning Letters about drug products so that they may take this information into account when considering the award of contracts.
In addition to the violations described above, we have the following comments concerning the label of your 0.43 oz Efficas Care packets handed out as promotional samples at the ASP conference. Even if your product was a medical food, it would not comply with the labeling requirements for a medical food because:
• The label does not include a statement of identity as required by 21 CFR 101.3.
• The label does not provide a list of ingredients as required by 21 CFR 101.4.
• The label does not provide the address of the manufacturer, packer or distributor as required by 21 CFR 101.5.
For your information, the statement "This unit is not for individual retail sale" does not exempt a promotional sample of a food from bearing the required label information.
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 response should be directed to Quyen Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions about this letter, please contact Mr. Tien at 215-717-3705.
Joseph R. Baca
Office of Compliance
Center for Food Safety
and Applied Nutrition
This page was posted on March 27, 2019.