From today's FDA Digest comes the following notice of action:
The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.
The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as "Chemicals found in Cherries may help fight diabetes." The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.
Under the terms of the consent decree, the companies have agreed to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims. They have also agreed to hire an independent expert to review the claims they make for their products and to certify that they have omitted all violative claims.
Brownwood Acres Foods has been a fruit industry mainstay of Michigan's Grand Traverse region for over 60 years. (Their main farm product business, Brownwood Farms, is unaffected by the FDA ruling; in fact, my mouth waters just looking at their dips, sauces, and preserves.). Known best for marketing locally-produced cherry and blueberry products, their offerings have expanded to fruit supplement products from Michigan and California through an arm of the company called Flavonoid Sciences. According to the Brownwood Acres website:
Brownwood Acres Foods has partnered with Robert and Janet Underwood, owners of Flavonoid Sciences and inventors of CherryFlex, Wild BlueberryIQ and Wonderful Pomegranate nutraceutical Softgels. The same technology used for the Softgels is now also available in the FRUITFASTtm line of fruit supplement bars. Having devoted over 40 years to farming fruit crops, the Underwood's have recognized the health benefits of whole fruit. Their proprietary process of capturing these benefits without altering the fresh fruits' properties remains unrivaled. This cutting edge technology maintains what Mother Nature intended for the body... only better... softgels made from the whole cherry, wonderful pomegranate and wild blueberry fruit.
Well, okay, these are not direct disease treatment claims and are well within the requirements of the 1994 Dietary Supplement Health and Education Act (DSHEA), the primary US legislation that governs the marketing and sale of botanical and non-botanical supplements in this country. In fact, anthocyanin and flavonoid compounds from cherries have been actively investigated for their anti-inflammatory activities. A clinical trial conducted at the University of California at Davis using reasonable consumption of Bing (sweet) cherries (280 g/day for 28 days; Prunus avium) revealed significant reductions in inflammatory mediators and markers like RANTES/CCL5, C-reactive protein, and nitric oxide. Extracts of sour or tart cherries (Prunus cerasus L.) like those grown in Michigan have also been shown to have anti-inflammatory activities in animal models, albeit at very high concentrations.
So, the potential for health benefits of cherries is not woo or quackery - but it is far too early to make drug claims for such products. To do so, one would have to embark on standard clinical safety and efficacy trials under the auspices of an investigational new drug application or IND (in the US). As the FDA stated, "The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as 'Chemicals found in Cherries may help fight diabetes.'"
Like many supplement manufacturers targeted for FDA action, this is where the manufacturers of the fruit products went wrong. Under the 'Health Claims' section of their website, direct, disease treatment claims were apparently made (which now notes, "We can no longer provide any information due to FDA regulations.")
But there's more in this case: this is what I think really caught the attention of the FDA and triggered their action:
Most recently, the companies' Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres' president and contained similar unproven statements claiming benefits for their products.[emphasis mine]
I'm not a lawyer but this sounds like a venture into marketing deception as well, an area where the US Federal Trade Commission has intervened in the past together with the FDA. As one might suspect, I can no longer find any cached web pages containing the "apparently independent Web site."
I discuss these kinds of issues quite a bit and readers may wonder why. The reason is that I am devoted to the scientific examination of natural products and their potential health benefits. But a threat to our research area are the unfounded claims of supplement manufacturers that cast a cloud over the entire field of natural products research.
In fact, even the hometown newspaper of Brownwood Acres, The Traverse City Record-Eagle, took the company to task in the interest of their own local economy in today's "Jeers" editorial section:
-- To the owners of Eastport-based Brownwood Acres Foods Inc. for making illegal claims about the alleged health benefits of their cherry-based products. The Food and Drug Administration had to file a formal complaint in U.S. District Court before the firm agreed to stop making claims that "(their) products could cure, mitigate, treat or prevent various diseases including ... cancer, arthritis, gout, urinary tract infections, heart disease and Alzheimer's disease," according to the complaint. The cherry industry has spent hundreds of thousands of dollars examining the health benefits of the fruit and don't need wild, unproven claims clouding the issue. [emphasis mine]
I happen to live in Traverse City.
As usual, the newspaper completely overdramatizes and obscures the facts.
The Cherry people have NOT in fact spent all that much money on health studies--as is amply demonstrated by the dearth of good clinical studies on the health benefits of cherries.
The temptation to tell stretchers in your promo is actionable, and deservedly so, but the temptation to do so is understandable.
Brownwood isn't looking to hoodwink anyone. They just overstepped the line--and they face the trouble that many producers of unpatentable remedies face: who's going to pay for expensive studies?
It's a shame, really, and undeserving of a jeer from an editorial board that, frankly, has no idea whatsoever of what they are talking about.
Treat Cancer with Flavonoids:
I agree, the company took it too far. Overall, however, I believe the actions of the FDA -- and not specifically explaining that the violation had to do with a website owned by the company-- do more harm than good for those who are trying to promote a healthy diet. People tell me all the time that my claims that fruits and vegetables can help prevent cancer are "unproven"; they don't believe even a scientific study, unless the FDA allows a label to be put on fruits and vegetables sold at the store. Meanwhile, the FDA allows cereals to claim they're good for the heart just because they contain a certain ingredient, although they also contain 19 grams of sugar per serving. It allows manufacturers to say that whole-grain Oreos are healthy, although the calories are astronomical and they really have no nutritional value.
Sure, cherries may not be proven to prevent those diseases that are listed; but eating cherries will be much, much healthier for someone than the junk that most people eat on a daily basis, which leads to clogged arteries, high cholesterol, and the chronic conditions that the FDA spends a lot of its time approving pharmaceuticals for.
I think overall, it sets back those who are looking to convince people that a healthy diet is in their best interest for their future health. People honestly don't believe it and will use snippets of these sorts of things they hear in the news to back their case for an unhealthy diet.
Of course, a lot of this is the company's fault for making claims backed by a website they owned; this was not the best way to go about things.