Subscribe for the latest consumer trends, trade news, nutrition science and regulatory updates in the supplement industry!
Join 37,000+ members. Yes, it's completely free.
FDA Says Flax Products are Misbranded
July 12, 2011
3 Min Read
MINNEAPOLIS, Minn.FDA warned Premium Gold Flax Products & Processing Inc. that its website claims misbrand its products unapproved drugs, according to a letter sent to Randy C. Miller, the companys president. FDA reviewed two websites maintained by the company, and found product claims were in violation of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act.
On a webpage titled Flaxseed in the News" on the companys site PremiumGoldFlax.com, FDA called out one article titled "Flaxseed Protects Against Cancer, Diabetes," which was aggregated from an Institute of Food Technologists article, according to Premium Gold Flax Products & Processing. FDA noted problems with the following statements:
"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 different paged within PremiumGoldFlax.com, titled "Flaxseed Health Benefits," FDA pointed to the following claims:
"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)"
And, a page titled "Health Benefits of Flax Hull Lignans" on that same site, had such troublesome statements, according to FDA:
"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."
On another site maintained by Gold Flax Products & Processing, FlaxHullLignan.com, FDA noted the page "Lignan Health Benefits" had this claim:
"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. Additionally, breast cancer cells treated with purified enterodiol and enterolactone have been shown to have a reduced ability to metastasize . 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."
Because these claims make the companys flaxseed products unapproved new drugs and are misbranded, FDA said Gold Flax Products & Processing had 15 working days of receipt of the letter to provide the specific steps the company has taken to correct the stated violations
You May Also Like
