Inspections, Compliance, Enforcement, and Criminal Investigations
HWW Enterprise Group 3/31/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
March 31, 2011
VIA UNITED PARCEL SERVICE
Mr. Michael Byrd
HWW Enterprise Group
460 Depot Street, Suite 188
Franklin, NC 28734
Dear Mr. Byrd:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.omega-3.us in March 2011 and has determined that your product, "Omega 3 Salmon Oil Plus" 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 establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act. Furthermore, your product's labeling fails to bear adequate directions for its intended use, causing the product to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 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)]. You may find the Act and the 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 the following, all of which are from webpages that are available through links from your website's home webpage (http://www.omega-3.us):
On the webpage, "Benefits Of Omega 3 Oil":
• "Reduced risk for heart disease, heart attack and stroke"
• "Lowers blood pressure, cholesterol and triglycerides"
• "Improves and even eliminates the symptoms of depression"
• "Positive effects on macular degeneration ... "
• "Reduced symptoms of Bipolar disorder"
• "Positive effects on lung, breast and prostate cancers"
• "Reduces symptoms of asthma and may even eliminate asthma in children"
On the webpage, "Benefits Of Omega 3 Fatty Acids For You":
• "These omega 3 benefits include ... less depression ... freedom from joint pain and protection against heart disease, prostate and breast cancer, diabetes .... "
• "[A] lack of DHA has been linked to PMS, depression, bipolar disorder, schizophrenia .... Research shows fish oil can relieve all these conditions."
• "Clinical trials also reveal another major result of taking fish oil is in preventing, reducing and treating inflammatory diseases like rheumatoid arthritis, ulcerative colitis, bursitis, cystitis .... "
• "Researchers even report fish oil effectively reduces Alzheimer's and significantly improves the survival rate and quality of life in terminally ill cancer patients."
On the webpage, "Benefits Of Omega 3 Fish Oil":
• "[O]mega 3 fish oil has been proven to lower cholesterol, triglycerides, LDLs and blood pressure."
• "The fatty acids in omega 3 fish oil have been proven to assist the body in reducing inflammation .... [T}he pain associated with arthritis (or cystitis, tendonitis, prostatitis, etc.) may be reduced or even eliminated."
• "Research scientists have now said that supplementing with omega 3 oils may 'alleviate' the symptoms of depression."
• "The research tells us that omega 3 fatty acids stop a normal cell from transforming into a cancerous mass . . . and they actually cause cellular death of cancer cells. This tells us that omega 3s can actually help slow down or prevent breast, color [sic] and prostate cancer."
• "[O]mega 3 oils also have positive effects on migraine headaches .... "
On the webpage, "Cancer Natural Solutions":
• "By ... taking Salmon Oil Plus, you can help protect yourself from colon and breast cancer, as well as sudden cardiac death, arthritis, diabetes and depression. And since there appears to be an HRT cancer link, omega 3 fatty acids can go a long way in protecting women who've had hormone replacement therapy."
On the webpage, "Fish Oil Research Proven Results":
• "Greatly reduced Inflammation and Pain. Omega 3 fish oil's polyunsaturated fatty acids (PUFAs) ... can help prevent and relieve painful conditions like arthritis, bursitis, prostatitis, cystitis and anything else ending in 'itis. "'
• "[F]or adults, PUFA's . . . reduce Alzheimer's disease."
• "Heightened Sense of Well Being with Less Depression. Many research studies have found that omega 3 can 'alleviate' the symptoms of depression, bipolar and psychosis."
• "Improved cholesterol and Tryglicerides [sic]. Omega 3 PUFAs, help to lower cholesterol and tryglicerides [sic] ... by lowering (bad) LDLs .... "
• "Lower Risk of Heart Attack and Stroke. Higher blood levels of omega 3 DPA and DHA have been shown to result in a 50% lower risk of developing heart disease. Besides lowering blood pressure, cholesterol and triglycerides, DPA and DHA also reduce plaque formation, platelet aggregation .... "
• "Reduced Incidence of Certain Cancers. Omega 3 fish oils have been shown to help prevent four of the most common forms of cancer- breast, colon, lung and prostate cancer. ... "
• "Less ADHD and Other Childhood Disorders. Studies show omega 3 PUFAs can prevent juvenile diabetes and reduce the symptoms of dyslexia, dyspraxia and compulsive disorders, including ADD and ADHD."
• "Research shows a high intake of PUFAs can help ... reduce children's asthma ... and protect against the development of chronic lung diseases, chronic bronchitis and emphysema."
• "...Less Skin Cancer. Studies show ... omega 3 PUFAs ... reduce psoriasis and help protect against skin cancer by controlling cancer cell reproduction."
On the webpage, "Natural Arthritis Pain Relief':
• "[O]mega 3 fish oil is the most effective arthritic pain reliever."
• "[T]he fatty acids found in Salmon Oil Plus are the most effective rheumatoid arthritis anti-inflammatory pain reliever."
• "A natural solution to your arthritis pain is possible -just give it a try!
On the webpage, "Pregnancy and Fertility":
• "[T]he omega 3 fatty acids will help prevent 'preeclampsia."'
• "For men, the omega 3s in fish oil prevent erectile dysfunction ... "
On the webpage, "Bipolar Omega 3 - Research Proven Results":
• "Research done at Harvard University and published in the Archives of General Psychiatry found that 'patients with bipolar disorder' saw a significant improvement in the course of their illness when given omega 3 fatty acids from fish. [Vol. 56 No.5]"
• "Omega 3 fish oil has been shown in study after study to be beneficial for depression, bipolar and all forms of psychosis."
• "Other researchers ... found that 'depressive symptoms can be alleviated by omega 3 PUFA [polyunsaturated fatty acid] supplementation.' [Vol. 48(2-3):149-55]"
• "More research, published in the American Journal of Psychiatry concluded that"' ... EPA may be a safe and effective form of monotherapy for women with moderately severe borderline personality disorder.' [Vol. 160:167-169]"
In addition, your website includes an interactive presentation which includes some of the same claims as noted above, including:
• "Research indicates that omega-3s may be especially beneficial in inhibiting cancers of the colon, pancreas, breast and prostate.''
• "Researchers suggest the depression could be overcome with omega-3 supplementation."
• "[S]upplementing with omega-3 fatty acids ... can prevent the onset of osteoarthritis.''
Your website also contains disease claims in the form of personal testimonials on the webpage, "Customer Comments on Omega 3 Fish Oil," which is available through the "Customer Comments" tab at the top of your website's home webpage, including:
• "I started taking Omega-3 Salmon Oil and it's been two months since I've had a migraine headache."
• "[I]n just over 2 months my cholesterol dropped 49 points and I'm now in the 'normal' range. My LDL dropped over 50 points and my triglycerides fell over 100 points."
• "I had very bad osteoarthritis in my low back . . . . After 2 weeks on Omega-3 Salmon Oil, I was able to take off my brace. And, after 4 weeks, the pain in my tailbone was gone for good!"
• "About six years ago I was scheduled for surgery for my irritable bowel.... I started on a supplement program that included the Salmon Oil.. .. Today, my MD says I have a clean bill of health. I no longer suffer the symptoms associated with irritable bowel ... !"
The claims listed above establish that your product is a drug, because it is intended for use in the cure, mitigation, treatment, or prevention of disease. See section 201(g)(1)(8) of the Act [21 U.S.C. § 321(g)(1)(8)]. Your 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. § 321(p)]. New drugs may not be legally marketed in the United States 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 product safely for its intended uses. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(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 deficiencies in 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 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 from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure 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 working days, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your written response to the attention of Marie Mathews, Compliance Officer, Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions regarding any issues in this letter, please contact Ms. Marie Mathews at (404) 253-1279.
John R. Gridley ,
Atlanta District Office
HWW Enterprise Group
213 Highlands Rd. #88
Franklin, NC 28734