| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
July 1, 2011
WARNING LETTER
Refer to MIN 11 - 35
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Randy C. Miller
President
Premium Gold Flax Products & Processing, Inc.
1321 12th Avenue Northeast
Denhoff, North Dakota 58430
Dear Mr. Miller:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your websites www.premiumgoldflax.com and www.FlaxHullLignan.com in May 2011. These reviews were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations contained within Title 21 of the Code of Federal Regulations (21 CFR). You can find the Act and related regulations through links on FDA's internet home page at www.fda.gov.
Unapproved New Drugs
Based on claims made on your websites at the Internet addresses www.premiumgoldflax.com and www.FlaxHullLignan.com, FDA has determined that your flaxseed products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the therapeutic claims observed on your websites include:
From www.premiumgoldflax.com:
From the main page, under the heading entitled "Flaxseed/Flax Hull Lignans" and the links to the following webpages:
On a webpage entitled "Flaxseed in the News":
• An article entitled "Flaxseed Protects Against Cancer, Diabetes"
• "Flaxseed is Rich in Omega-3 Fatty Acids: Omega-3 fatty acids are a key force against inflammation . . .. Evidence shows that inflammation plays a part in ... heart disease, arthritis, asthma, diabetes, and even some cancers. Inflammation ... may be enhanced by having too little omega-3 fatty acid intake ...."
• "There is evidence that lignans [contained in flaxseed] may ... prevent breast cancer."
• "[L]ignans [contained in flaxseed] help prevent Type 2 diabetes."
• "Flaxseed Lowers High Cholesterol ...."
On a webpage entitled "Flaxseed Health Benefits":
• "Other benefits [of omega-3 fatty acids found in flaxseed] include ... reducing inflammation."
• "Golden flaxseed is also high in lignans, which aid in the prevention of cancer ...."
• "Health benefits from flaxseed may include:
• Reduction of LDL cholesterol ....
• May reduce hear [sic] arrhythmia during 'coronary events' (Bierenbaum and Alexander)
• Anti-inflammatory effects. (Zurier and Kelly)
• Helps glucose control in diabetes. (Cunnane)
• Reduces some psoriasis. (Simopoulos)"
On a webpage entitled "Health Benefits of Flax Hull Lignans":
• "Flaxseed is ... loaded with lignans, natural cancer-preventative phytonutrients."
• "[E]vidence surrounding the dietary benefits of consuming food with high lignan content revolves around the low incidence of breast, colon and prostate cancers found with those people who regularly eat food with high lignan content. Research findings are concluding that the chemical release of these plant hormones in the body, are able to block the action of certain cancer-causing substances."
From www.flaxHullLignan.com:
From the main page on the link "Lignan Health Benefits":
"Flaxseeds have also been beneficial in treating breast cancer in animals. A reduction in breast tumor growth, as well as reductions in levels of compounds involved in tumor growth and metastasis (cancer cells spreading throughout the body), have been shown to occur after supplementing with flaxseeds and/or plant lignan extracts (2, 9). Additionally, breast cancer cells treated with purified enterodiol and enterolactone have been shown to have a reduced ability to metastasize (1). This effect of flaxseed is similar to that of the breast cancer drug, Tamoxifen. The positive effects of flaxseed in these studies have been shown both in breast cancers that express estrogen receptors and in those that do not, suggesting that these effects may be mediated through estrogen-like lignan activity and also by some other, still to be determined, physiological mechanism.(1)."
The therapeutic claims listed above establish that your flaxseed products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. See section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B). 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 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 flaxseed products are 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 these products safely for their intended uses. Thus, your flaxseed products are misbranded under section 502(f)(1) of the Act, 21 U.S.C. 352(f)(1), in that the labeling for these products 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).
This letter is not intended 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 Act and its implementing regulations. FDA regulations are available at FDA's website at www.fda.gov.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by FDA without further notice. The Act provides for the seizure of illegal products and injunctions against the manufacturer and distributor of illegal products, 21 U.S.C. §§ 332 and 334.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to ensure that similar violations will not recur. Include in your response any documentation showing the corrective actions taken or proposed to be taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented. Your reply should be sent to the attention of Compliance Officer Demetria L. Lueneburg at the address on the letterhead. If you have any questions regarding any issues in this letter, please contact Compliance Officer Lueneburg at (612) 758-7210.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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