- Excerpt
Around the world, Governments are continuously busy regulating what “food business operators” are allowed, not allowed and what they must tell consumers about the content and effects of their products. Government interventionists, regulators and “experts” pretend to know what’s good for you and because of this, they, not you, must decide which information you shall and, more in particular, which information you shall not receive. As a result, practically all the information that you find on a food product now uniformly comes from or is strictly regulated by your government. In other words, the labels and packagings of food products now serve as a “platform” for government-controlled information. When you read what’s printed on a food product’s label or package, you take it for granted that you’re receiving information that comes from that product’s manufacturer. In fact, it’s your Government that’s anonymously talking to you.
Regulating the term “antioxidant”
Health conscious consumers have become aware of the many health benefits of nutrients that are characterized as “antioxidants”. These nutrients’ main benefit is that they are capable of neutralizing free radicals. Some 30 years ago, food supplements containing antioxidants began to gain traction as a vitally important category of health products. As if on cue, Governments promptly began to strictly regulate commercial use of the term “antioxidant”. So it was that, on the 9th of June 1997, in the United States of America, the Food and Drug Agency (FDA) determined that the term “antioxidant”, although it clearly characterizes antioxidative substances, had to be regarded as a “health claim”. As a consequence, attributing antioxidant activity to a nutrient is only permited if the activity is officially “recognized” as based on scientific evidence that shows that “the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions”.
The FDA’s arbitrary cut-off point
While that still sounds quite reasonable, the FDA also determined that a nutrient contained in a food may only be characterized as an “antioxidant” when an officially recognized Recommended Daily Intake (RDI) has been established for that nutrient. Such government-authorized RDI’s have been established for most vitamins and minerals. They indicate the daily nutritional intake necessary to prevent deficiency diseases such as rickets, scurvy and pellagra. When it comes to botanical extracts such as those containing OPCs, the fact that such extracts are not single substances but complex compounds consisting of many constituents, makes it technically and physiologically impossible to establish such RDI’s for them. Which doesn’t mean, by the way, that it is impossible to recommend daily intakes required to produce their benefits. In any case, by setting the absolutely irrelevant and bureaucratic RDI-based provision as the cut-off point for use of the term “antioxidant”, all botanical nutrients for which no RDI has been established would have been deprived of being presented as antioxidant on the labels of food products. The only antioxidants that survived the onslaught were and to this very day are the vitamins C and E, and beta-carotene. [i]
Prof. Masquelier’s Open Letter response
During the early 1990s, several years before the FDA announced its attack on antioxidants, Masquelier’s OPCs had been successfully introduced to the American market as having a strong and proven antioxidative capacity. Having learned about FDA’s stance, I informed Masquelier and asked him to write an Open Letter in response to FDA’s determination to limit the use of the term antioxidant to vitamins C and E and beta-carotene, thus prohibiting suppliers of his OPCs to identify them as antioxidants and highlight their strong antioxidant activity. And so, on the 25th of March 1996, we published the following statement:
American Paradox?
Undeniably, there is considerable confusion at present in the field of dietetics and nutritional supplements with regard to the actual antioxidant effects of the plethora of formulas currently on offer to the public. It is not exceptional to see a dozen or more substances claimed to fill this function on one and the same package, and the profusion of ingredients hangs question marks over the efficacy of each of them. Very wisely, the F.D.A. points out that molecules whose antioxidant power in vivo has been irrefutably proven in humans are rare - hence its very narrow selection of the three aforementioned vitamins.
I believe, however, that this reductive stance ought to be moderated, and it should be admitted that the FDA's choice is not the only possible choice with regard to beneficial effects, particularly when an idea that originated in the United States has been so enthusiastically received by the American people. I would like to refer to the French Paradox. Conceived in 1991 and disseminated by Lewis Perdue's book [ii], the idea has proven to be of far greater consequence than a mere media rage. It attributes the low death rate of the French from heart disease to their regular consumption of red wine together with a Mediterranean type of diet. In fact, the French Paradox reveals to the public and proclaims to the world at large ideas that have long been known by a small circle of scientists. For example, as early as 1957, in the U.S.A., FAY-MORGAN [iii] noted that laboratory animals given wine retain significantly less cholesterol than those given water or diluted alcohol. I myself announced the ability of wine to break down cholesterol at the international medical conference held in Bordeaux in 1961 [iv]. I attributed this phenomenon to tannins, and particularly to OPCs (procyanidolic oligomers) which I had discovered shortly before in wine [v].
Due to their protective effect on the blood vessels [vi], these OPCs later found their way into medicine: the active ingredient in the drug ENDOTELON, manufactured by SANOFI WINTHROP, is derived from grape seeds. When St Leger published his famous article in the Lancet in 1979 on the protective effect of wine in relation to death from heart disease [vii], an entire body of previous literature, which already held the answer to the problem he had just raised, was mysteriously left unmentioned.
Nowadays, more is known about the pathogenics of atheroma. We know that the fatty deposit of the lesion is the result of peroxidation of the LDL fraction transporting the cholesterol. Oxygenic free radicals are involved in this reaction. We can deduce from this that the benefit derived by the French from their way of life is based on the fact that their diet is rich in natural antioxidants, red wine being the main source of these. Although wine is devoid of vitamin C, vitamin E or beta-carotene, its OPC content is superior to all the other food sources: it is not unusual to find a gram in a litre of red wine.
In 1985 I patented the antiradical effects of OPCs and their use in medicine, food products and cosmetics in the USA [viii]. Two years later, the Japanese biologist Uchida confirmed this antiradical effect of OPC, which he found to be 50 times superior to that of vitamin E [ix]. In 1993, Frankel [x] showed that the antioxidants in wine inhibit the peroxidation of human LDL. Finally, in 1995, Renaud [xi], working in my laboratory on OPC extracted from grapes, attributed to them the capacity to prevent thrombocytic clotting and the rebound phenomenon characteristic of alcohol.
A decade of recent research has thus furnished proof that the cardiovascular protection of the French Paradox is largely based on the antioxidant properties of OPCs. Ignoring this evidence opens the way to the American Paradox, where we see the F.D.A. turning its back on one of the most significant contributions made toward human biology as we near the end of the century. Obviously, all new products for use in dietetics and medicine should be screened extremely rigorously, but let's face it, OPCs are not the result of some recent synthesis. People have been eating them since they started eating fruit and vegetables. Even before the arrival of humans on earth, OPCs were exercising their antioxidative powers in the tissues of vegetation which would otherwise have succumbed to the aggressions of free radicals. Why does one find OPC in such large amounts, as in grape seeds, for example? Simply because they protect the fragile oil of these seeds from the degenerative effects of oxidation. our increased need of antioxidants is due to the current sophistication of our food. We resort to red wine because botanic selection and cooking habits have depleted our dietary sources of OPCs.
The fact that the F.D.A. is uninterested in a vegetable product designed to protect the most fragile structures in the living cell would appear proof of its indifference towards the problem of aging. The American people, on the other hand, are not mistaken in their increasing consumption of OPCs in the form of nutritional supplements.
Let us hope that the F.D.A. will add OPC to the trilogy of C, E and beta-carotene, confirming their prior choice by countless users throughout the world.
J. Masquelier,
Martillac, France, 25 March 1996
The FDA was forced to back off
Fortunately, Masquelier’s and our hope that his Open Letter would change things for the better was not in vain. In the ensuing lawsuit brought against the FDA, it provided ammunition for the attorneys representing the American distributor of Masquelier’s OPCs to stop the FDA from doing what the agency had proposed. The legal team (xii) successfully argued that if a non-RDI compound, such as OPCs, meets the definition of antioxidant, the FDA may not prevent a company from making a claim in food and dietary supplement labeling about its antioxidant function. In practice, this means claims such as: “Masquelier’s Original OPCs supply powerful antioxidant activity to protect cells from free radical damage” do not violate the Regulation and may still be made.
Recommended intake of OPCs as antioxidant ?
However, a claim such as “high in antioxidant OPCs” or “rich in antioxidant OPCs” would violate the regulation because a claim suggesting an amount of an antioxidant in a product may only be made for RDI nutrients, and to make such claim, the RDI nutrient must meet the terms of the Regulation. For example, “high in antioxidant Vitamin C” requires that a serving of the food or dietary supplement provides at least 20% of the Daily Value for that nutrient. Nevertheless, American consumers did manage to learn about the daily intake of Masquelier’s OPCs required to produce the claimed antioxidative effect as they became aware of the fact that, in his U.S. ‘360 Patent, Masquelier recommended that to obtain a significant free radical scavenging effect, one must consume 1.5 to 3 mg per day per kilogram of body weight. For an adult person weighing 70 kg, this comes down to a daily dose of about 100 to 200 mg of OPCs. Which means that in case of use by children, a daily 50 mg unit dose would fit children weighing between 17 and 33 kg, while a 2 x 50 mg unit dose would fit children weighing between 34 and 66 kg.
Antioxidants in Europe ?
In 2007, the European Commission followed suit and, like the FDA, determined that the term “antioxidant” must be understood as a “health claim” when used in “commercial communication”. With this decision, it placed the use of the term within the scope of the European Health Claims Regulation. In this article, I won’t delve into the disastrous effects of this Regulation. I refer readers who are interested in this subject to my Health Claims Censored book and website. Anyway, the long and short of it is that European consumers who want to find out about the health effects of nutrients and foods are advised to look beyond what’s on the labels and packagings of food products. Just go online and search for whatever it is that you’re interested in. Yes, indeed, this requires that you must take action when you want to make your own decisions about your health. But when you do, you will find that, no matter what European bureaucrats and “experts” may or may not think, Masquelier’s OPCs are fine antioxidants that deserve a place in your daily intake of food supplements. But, don’t take my word for it. Just reread Masquelier’s Open Letter to the FDA.
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