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Action Alert: FTC Outlaws Green Product

Tue, 17 Nov 2015 18:03:39 +0000

Related article: Ban New Green Products?
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Two Clinical Trials for Fruit Juice? That’s What the FTC Was Demanding!

Mon, 02 Feb 2015 22:49:41 +0000

In breaking news, the DC Appeals Court says that would be unconstitutional. But the rest of the decision in the POM Wonderful case was disappointing.
Last August, ANH-USA filed a friend-of-the-court (amicus) brief in support of POM Wonderful. The Federal Trade Commission had barred the pomegranate juice company (and, by extension, other natural product companies) from advertising any so-called disease-related claims about their product unless it is backed by two random-controlled trials (RCTs).
RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two, for each product for which they might wish to make a disease claim. A disease claim, under federal law, is any health claim that gets specific. For example, “better heart health” would not be a disease claim. But lowering blood pressure would be. The FTC’s order basically warned food and supplement producers never to make a specific disease claim unless they were prepared to spend what could be hundreds of millions of dollars on an unpatentable product.
The pomegranate juice company has spent many millions on health research of its own in addition to relying on academic research. It fought back, appealed the ruling, and the case was being heard in the DC Court of Appeals. On January 30, the three-judge panel returned its decision: the FTC’s blanket requirement of at least two RCTs as a precondition to any disease-related claim is indeed unconstitutional under the First Amendment—just as we had maintained in our brief.
The court stated that the FTC must “demonstrate a ‘reasonable fit’ between the particular means chosen and the government interest pursued….Here the commission fails adequately to justify a categorical floor of two RCTs for any and all disease claims.” The court noted that requiring two RCTs without justification would be very costly, and could ultimately deny consumers useful and truthful information about products. This would, in the words of the ruling, “subvert rather than promote the objectives of the commercial speech doctrine.”
So far so good. But then the court’s logic got very murky. Although a requirement for two random-controlled trials would be unconstitutional, one could be OK. Huh?
This is just one case. But based on this precedent, it’s likely that a future court would require at least one RCT. Depending on the quality of the clinical trial and the type of disease claims being demonstrated, the number of RCTs required may vary.
As we have long noted, RTCs don’t even fit food and supplement research perfectly. A drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements are just part of our diet and often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, but isolating it for an RCT would miss that. In addition, the effect of a food or supplement will depend in the first place on whether the subject is deficient in that nutrient. No one is nutritionally deficient in a drug. Random choice of participants for a food or supplement study is therefore illogical.
The court in this case stated that any commercial speech restriction must “directly advance the governmental interest” and “[must not be] more extensive than necessary to serve [that] interest.” This is an interesting choice of words. We would have thought that we should worry about the public interest, which is not necessarily the same as the government’s interest. In any event, it seems the only reason the court struck down the two-RCT requirement is because there could be less restrictive means to the same end, such as one RCT.
Our amicus brief highlighted another important issue as well. We argued that the FTC’s RCT requirement violates the notice-and-comment rulemaking process—that the FTC is essentially making new law, and must give the American public sufficient time to make formal comments. We made the same argument in our Citizen Petition to the FTC. Unfortunately, the court disagreed, in effect saying the FTC is free to create law this way where they are not specifically altering current law.
ANH-USA will continue working to rein in the FTC as it tries to make new law on its own. The appeals court’s word is not final. We’ll keep you posted.

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ANH-USA Files Brief in Free Speech Case

Tue, 27 Aug 2013 14:00:04 +0000

This time it is the Federal Trade Commission (FTC) which is acting lawlessly and trying to censor science about natural health products.

The Alliance for Natural Health USA has filed an amicus brief drafted by famed constitutional lawyer Jonathan Emord in support of POM Wonderful’s suit against the Federal Trade Commission. (An amicus brief is a legal opinion submitted to the court by a third party.) We are participating in the discussion not only because we want to protect free speech rights for natural products, but also to protect consumer access to information about the therapeutic effects of natural products.

You may recall the FTC’s lawsuits against companies such as POM Wonderful for alleged false advertising, even though all POM did was cite legitimate scientific articles and studies. In January, the FTC ruled that 34 of POM’s advertising claims (out of a total of 43) were “implied disease claims,” and issued a cease-and-desist order restraining POM’s future advertising.

In March, POM filed a petition for review of the FTC’s order. Our amicus curiae (or “friend of the court”) brief is in support of that petition.

Our brief offers the legal opinion that in issuing its cease-and-desist order, the FTC violated the First Amendment, as well as the Administrative Procedures Act, the law that governs the way in which agencies of the federal government may propose and establish regulations.

The really egregious part of the FTC’s order prohibits POM (and, by extension, other natural product companies) from advertising any disease-related claims about their product unless it is backed by two random-controlled trials (RCTs). RCTs are immensely expensive, and many natural products companies could never afford one RCT, let alone two for each product for which they might wish to make a disease claim.

In this case, by the FTC expert’s own estimate, each RCT would cost roughly $600 million, and involve between 10,000 and 30,000 participants. For non-patentable products such as nutritional supplements, the manufacturer could never hope to recoup their outlay in RCTs, even if they could afford them in the first place. This is the “Catch-22” we have talked about that is stifling natural products. Since natural products are not patentable, nobody can afford to run RCTs and get FDA (or now FTC) approval. But without FDA approval, no disease claims may be made. In this way, we arbitrarily banish all natural products from organized medicine. People suffer and die so that patent drug company profits will not be jeopardized.

The Catch-22 as enforced by the FDA is legal—the law is tilted toward drug companies with their huge lobbying presence, campaign contributions, and jobs. But the same Catch-22 is not legal for the FTC to enforce. There is nothing in their statute to support it; they are acting completely outside the law.

The FTC has also totally ignored the $35 million of peer-reviewed scientific research that POM had already compiled. We point out in our brief that the FTC’s new rule suppresses the full range of scientific evidence available— including observational studies, animal studies, ecological studies, etc.—in favor of only one scientific approach, the RCT.

As we further note in our brief:

The FTC’s new rule suppresses the publication in consumer markets of nearly all nutrition science, which science is evident in the totality of scientific evidence (and not in RCTs to the exclusion of other evidence)…. The [agency’s] requirement for at least two RCTs, at a potential cost of perhaps $1.2 billion, effectively rids the market of vital health information through an impractical and unnecessarily high standard and related cost.

The agency also violated the Administrative Procedures Act (APA), because it made the RCT requirement without explaining why RCTs are the only acceptable standard for so-called “truthful disease-related claims.” As we have pointed out before, there is serious scientific criticism of RCTs. They are not necessarily the “gold standard” of proof as often alleged. It is not just the way they are run, which is often flawed. It is also that by their very nature they are more suitable for drugs than for food or supplements, where many co-factors are usually involved.

Moreover, the RCT standard was not made through a formal rulemaking process, where the public is allowed to comment on the rule, but instead was set in place, company by company, via punitive consent decrees. Companies find it difficult to fight these proposed consent decrees because the government has unlimited legal funds and the companies often have few resources. Moreover, if the government wants to be punitive and vindictive, it can just keep raising one charge after another.

This actually happened in the POM Case. When POM publicly challenged the FTC’s new approach, it led the agency to launch charges against POM products. Does this sound like the US, or a fascist country? At the very least it is a case of government bullying, which is all too common these days.

ANH-USA has always championed free speech, and with your support and activism we’ll protect the public’s access to information about natural products—in particular, how they can be used to treat chronic illnesses and imbalances, and even cure diseases. That’s why this petition will, we believe, be so precedent-setting, and so important for people like you and your family.

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FTC Proceeds with Raw Power Grab on Health Claims—In Effect Thumbing Its Nose at Congress

Tue, 22 Jan 2013 21:00:38 +0000

Food company POM Wonderful’s battle with the FTC ends (for now) with the agency making up its own law and quashing free speech. Action Alert!

Last year, an administrative law judge (ALJ)* for the Federal Trade Commission upheld the pomegranate juice manufacturer’s right to make what the FDA would call structure/function claims in ads. Structure/function claims include statements such as “calcium helps build bones.” They don’t directly talk about curing a disease. At the same time, the ALJ found that some of the company’s claims went too far (specifically where they claimed the juice could help heart disease, prostate cancer, and erectile dysfunction).
Because the ALJ’s decision was a partial victory for both POM Wonderful and the FTC, both sides appealed, which necessitated a ruling from the FTC as a whole. Last Wednesday, the Commission took a much more unreasonable line. It found that thirty-four of POM’s forty-three claims were implied disease claims—fifteen more than the ALJ had found. The full Commission further ruled that a double-blind random-controlled trial (RCT) is required for any “efficacy” claim and two double blind RCTs for any claim that might seem to be related to a disease. The $35 million on peer-reviewed scientific research previously spent by POM was brushed aside because the studies were not RCTs, which are commonly used for drug testing.
This is a major one–two punch. The FTC is being draconian about what it considers an implied disease claim. One commissioner noted in remarks accompanying the decision: “It is difficult to imagine any structure/function claims that POM could associate with its products in the marketplace without such claims being interpreted, under the FTC precedent set in this case, as disease-related claims.”
In making these judgments, the agency has relied on what is legally called its own “net impression,” i.e., totally subjective judgment, and has ignored the ALJ’s request for a higher standard of “extrinsic evidence,” the sort of evidence that would come for example by testing how consumers actually interpret a label.
The agency is also requiring the hugely expensive pharmaceutical standard of the double-blind RCTs. As we have often noted, companies do not usually attempt RCTs because of their expense, unless they hold a patent on the substance being tested. And it is not possible to patent natural substances such as food. The FTC understands this. In effect, they are saying that food manufacturers will not be allowed to talk about health benefits, period. It is a complete gag order.
The ruling also blurs the line between the FTC and the FDA. The double-blind RCT for disease claims is an FDA labeling standard for drugs. The FTC is supposed to regulate advertising, not decide what is a drug. Its mandate is to ensure that advertisements are not deceptive or misleading—something that certainly does not require the pharmaceutical RTC standard! Now the FTC is unnecessarily and arbitrarily deciding to use an FDA drug standard for disease claims in advertising. Some industry observers even wonder whether the FDA has asked the FTC to do this because the FDA would not be able to go this far on its own.
There is absolutely no statute justifying this. It is making up law without congressional approval. Congressman Henry Waxman (D-CA) in particular has already tried and failed to give the agency the power to do this—in a sneaky and underhanded way. You may recall that in 2010, Waxman tried to slip an amendment into a totally unrelated bill. That amendment, which was intentionally written in obscure language that nobody but an expert could understand, would have given the FTC expanded powers and rulemaking authority, giving them the power to create new kinds of regulations without going back to Congress. (It lost that authority in the 1980s because Congress thought the FTC was abusing it. How ironic.) With your help, the amendment failed. Having in effect been told no by Congress, the agency is just going ahead anyway, seemingly on a case-by-case basis, creating regulations with no legal basis.
Who benefits from such a change in policy? Just follow the money. If the FTC prevails in requiring double-blind RCTs, only pharmaceutical companies will be able to make health claims on their patented and FDA-approved products.
The Commission’s decision directly affects only POM Wonderful (along with all its affiliated companies despite the fact that POM was the only company at issue here!). But it sets a powerful precedent and makes it clear that the FTC will try to enforce this as widely as possible.
Food, drug, and constitutional law attorney Jonathan Emord called the decision “arbitrary and capricious” and said, “The breadth of [the FTC’s new two-RCT] requirement is truly astonishing….After today’s decision, the health marketplace will be dumbed down considerably to the detriment of health conscious consumers….In the end, that will mean a loss in public health as there will now be a multi-million dollar entry fee imposed on any who would wish to convey a health benefit to consumers in the market.”
This is just one more reason we need to pass the Free Speech about Science Act, which would allow natural product companies to cite peer-reviewed science in their advertising.
For now, we need to let Congress know that the FTC is trying to make an end run around the legislative process. Having been turned down by Congress, the FTC is proceeding as though empowered anyway. Action Alert! Let’s be sure that Congress understands that voters are watching, and voters care about this example of agency lawlessness. Please take action now.

* An administrative law judge does the initial hearing of cases in the FTC’s administrative complaint proceeding. The ALJ issues the initial decision setting out relevant findings, explains the legal standard, applies the law, and issues an order. Only if the ALJ’s ruling is appealed does the case go before the full Commission.

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EU Quashes Free Speech in Health Claims

Tue, 18 Dec 2012 23:04:48 +0000

Europe has rejected 95% of the health and nutrition claims under review. What does this mean for us?

The European Food Safety Authority (EFSA) evaluated 2,037 health claims—that is, statements that a nutrient or food contributes to or has a positive impact on a particular health condition—and authorized the use of only 241 of them. Most of the ones accepted were related to structure or function claims, such as “calcium contributes to normal muscle function.”
As we’ve reported previously, structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans. In the US, structure/function claims like “calcium builds strong bones” or “vitamin D boosts immune system function” are allowed, but one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. With the EU’s list, we see the same censorship at work, only more so.
Claims that were rejected as being unacceptable included “(Cow’s) Milk products help support dental health. (Cow’s) Milk helps support the normal and healthy development of teeth. (Cow’s) Milk contributes to dental health” and “Vitamin D is needed for the normal/proper function of the thyroid. Vitamin D is needed for the proper regulation of blood calcium levels.”
Food and supplement products in the European Union must comply with this permitted list of health claims for use on food packaging, or else face prosecution for misleading marketing.
The EU created its Nutrition and Health Claims Regulation in 2006 to ensure that consumers were not misled by “unsubstantiated, exaggerated, or untruthful claims.” But we would ask: aren’t they misleading consumers into thinking that there aren’t benefits from food or dietary supplements, when the science overwhelmingly shows the opposite to be true? For example, we have the Harvard study that found a bioflavonoid in apples called rutin prevents clotting, and the studies indicating that medium chain triglycerides in coconut oil can prevent Alzheimer’s. But none of that would impress the EU unless a big company got behind it.
As ANH-International’s executive director, Robert Verkerk, noted on the BBC’s You and Yours program, some rules prevent you from claiming that fruit is beneficial, or that a diet rich in vegetables helps regulate body weight. Dr. Verkerk also said that big food companies, with their deep pockets, could play the system and claim health benefits for their food simply by inserting a small amount of an approved ingredient into a product.
As constitutional rights attorney Jonathan Emord points out, accurate health claims are a matter of safety. For example, the FDA would permit the following structure/function supplement claim: “This product supports healthy ranges of [blood sugar, blood pressure, or cholesterol]. But that doesn’t say enough. Someone on insulin should have clear information that a supplement could lower their blood sugar, in order to avoid a dangerous nutrient-drug interaction.
How will this new European regime of banning and forbidding affect American citizens? Potentially quite a lot. The EU is doing what the FDA wants to do and would do if it could. As it is, our system is not far behind the EU’s. For example, the current NDI draft guidance mirrors the EU’s Novel Food Regulation. The EU and the US have similar ways of determining “safe” upper levels of nutrient intake. And, as we reported last week, the EU is taking their anti-free speech position worldwide, insisting during Codex meetings that no language should be allowed indicating that food prevents disease, even in the case of nutrient deficiency illnesses.
This free speech issue is echoed in the POM Wonderful case, where the FDA attempted to bar a claim about the health benefits of pomegranate juice unless the company met a standard applicable only to drugs. As Jonathan Emord points out in a recent blog post, POM Wonderful’s court win could be reversed a month from now: the FTC has appealed the May 2012 ruling that POM’s structure/function claims don’t need to be supported by two random-controlled human clinical trials (RCTs). The final decision is expected on January 18. If the FTC wins, the two-RCT requirement could take effect in a little over a month.
What’s wrong with these trials? As we have noted many times, they are too expensive for most companies because the products ingredients are natural and cannot be patented. Without patents, there is no way to cover the exorbitant cost. The FTC and FDA know all this: they are just protecting drug companies, which in the case of the FDA pay much of the agency’s budget.
This is a reminder why the Free Speech About Science Act (FSAS) is so important. It will enable food and supplement companies to cite scientific evidence of benefits. It will ensure that free speech about science will be preserved, even while regulators and politicians such as Senator Dick Durbin and Congressman Henry Waxman try to bring EU regulations to the US.

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Readers’ Corner: The POM Wonderful “Win”

Tue, 29 May 2012 17:00:22 +0000

Some of our readers wondered about contradictory major media headlines. The facts of the case follow.

Last week we reported on the court decision in favor of pomegranate maker POM Wonderful, allowing the company to tell consumers about the health benefits of its juice.

Pat writes: “Moments after reading this article claiming the ‘win’ I saw the Yahoo headline below.”

The headline reads: “Pomegranate juice claims deceptive, US rules.”
We saw that too. The New York Times and many others are also reporting the POM Wonderful decision as a loss for POM, but this is a case where the media are completely misrepresenting the story. This is either gross media bias or simple ignorance; we can’t really say which. What we can say is that it is a disgrace to report without carefully checking facts or providing context.
The judge in the case issued a 335-page decision, so there was a lot in it. He found that product claims don’t need double-blind Random Controlled Trials (RCTs) to support them, and that claims don’t need to be FDA-approved. This is hugely important win and the heart of the case.
The judge’s decision is a major roadblock to the FTC’s and FDA’s desire to create a pharmaceutical-like pre-approval system for supplements. It reaffirms existing law which forbids such pharmaceutical standards. The idea of treating supplements as if they were drugs may sound good to an uninformed public, but it would really mean the end of supplements. A natural food or supplement ingredient cannot, in general, be patented because it is a natural substance, and without patent protection it can never get an exclusive share of the market and recoup the investment of millions of dollars it takes to do those double-blind RCTs.
The judge also found that the evidence POM Wonderful presented to substantiate some of its ads—specifically, the ones allegedly claiming that POM products treat, prevent, or reduce the risk of heart disease, prostate cancer, or erectile dysfunction—was inadequate. This was not a surprise. It is very difficult under existing law for a supplement to make a disease claim or what can be interpreted as a disease claim. But for the media to trumpet this in headlines and present it as evidence that POM “lost” is completely misleading. POM won its case, and so did natural health.
Over the past couple of years, the FTC has been requiring two RCTs as part of lawsuit settlement agreements (“consent decrees”). As we have reported, this is illegal, and FTC has been attempting to circumvent the rulemaking process by creating new law this way. In fact, the reason ANH-USA filed a Petition for Rulemaking against the FTC was that we have every reason to believe FTC will continue in this practice, and as we note above, companies simply cannot afford to perform two RCTs for each claim on each product.
Note that structure/function claims are completely legal under DSHEA, so what FTC was doing here is in opposition to the law governing supplements. There is little enough information we are currently allowed access—we can’t risk even that little bit being trampled. That is why this ruling matters.

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Breaking News: Big Scientific Free Speech Win!

Mon, 21 May 2012 22:24:27 +0000

In a 335-page ruling handed down today, an Administrative Law Judge with oversight of the Federal Trade Commission (FTC) has upheld the right of pomegranate juice manufacturer POM Wonderful to tell consumers about the health benefits of its juice.
Since 1996, POM has invested over $35 million to do scientific research on their pomegranate products at 44 top universities and scientific centers around the globe. Over 70 of their studies have been published in significant peer-reviewed journals, validating the health benefits of the pomegranate and pomegranate juice.
What makes this ruling significant is the fact that the judge said, “The greater weight of the persuasive expert testimony in this case leads to the conclusion that where the product is absolutely safe, like POM Products, and where the claim or advertisement does not suggest that the product be used as a substitute for conventional medical care or treatment, then it is appropriate to favor disclosure.” While we are still studying the ruling, it seems to indicate that other safe products may also be allowed to disclose scientifically validated studies about their health benefits.
The ruling also implies that Roll Global, POM Wonderful’s parent company, will not need to get FDA approval before making health claims about its food products, nor will it have to conduct the kind of double-blind, randomized, placebo-controlled studies that are required of the pharmaceutical industry, and which the FTC was illegally insisting on.
As we reported last year, the FDA allows food and supplement producers to describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” However, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden.
The FTC, however, has been claiming that even structure/function claims cannot be made unless two random-controlled human clinical trials, or RCTs, are performed! And that’s two RCTs for each product, not each ingredient. Even one RCT is tremendously expensive, so to require two for each product before any health claim is made is a nearly impossible undertaking.
Both FDA and the FTC regulate health claims about food (and dietary supplements are defined as a food), but the FTC covers health claims in advertising, whereas the FDA is concerned with health claims on food product labeling. The difficulty here is that through a series of lawsuit settlement agreements (“consent decrees”) taken against food companies by the FTC, the lines between the FTC and the FDA jurisdictions are blurring, particularly in regard to health claims. In its consent agreements—under threat of severe sanction if not agreed to—the FTC has forced companies to agree that no advertising claims could be made unless (a) there was prior approval by the FDA, and (b) it was supported by two double-blind, placebo-controlled studies—a pharmaceutical standard.
In 2010, POM Wonderful sued the FTC for blurring those lines. POM alleged that the FTC was trampling on their first amendment rights to make claims about pomegranates and pomegranate juice—claims that they said were supported by reliable scientific evidence. POM argued that FTC was illegally trying to create a new standard, whereas the current legal standard is that a claim does not require FDA approval and must simply be supported by competent, reliable, scientific evidence.
Constitutional lawyer Jonathan Emord put it this way:

The [FTC] cannot make unencumbered commercial speech dependent upon anything other than the requirement that the speech be non-misleading. Speech not approved by FDA may be true. Speech not supported by a set number and kind of human trials may also be true. The constitutional burden of proof is on FTC to prove falsity in each specific case based on the precise content of the claim.

As another article in this issue makes clear, the battle for free speech about science is still far from won. We are only in the early days. But the POM case is a major step forward and worth celebrating.

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FDA, Under Court Order, Nevertheless Refuses to Allow Truthful Claims Based on Good Science

Mon, 21 May 2012 22:24:21 +0000

You would think the FDA would obey a judge’s ruling on qualified health claims. Think again.
The FTC case described elsewhere in this issue was especially important because the FDA was hoping to use the FTC to evade some recent court rulings that it cannot willfully and unreasonably censor all science about food and supplements. Meanwhile the FDA continues to dig in its heels on the same subject.
As you know, we have for some time been fighting for freedom of speech with the FDA. Supplement and food companies are allowed by law to make qualified health claims (QHCs) on their labels if they are approved by the FDA. However, QHCs are rarely approved by FDA, and when they are, the FDA-approved language usually undermines the meaning. Because of their denial of two health claims (that vitamin C reduces the risk of gastric cancer, and the vitamin E reduces the risk of bladder cancer), we took FDA to court—and won.
FDA was then ordered by the court to revise those QHCs. They did, and we have just received the revised versions—and they are as bad and intentionally misleading as before! The new QHCs all have the qualifier that “FDA has concluded there is very little scientific evidence for this claim.” Example: “Vitamin C may reduce the risk of gastric cancer although the FDA has concluded that there is very little scientific evidence for this claim.”
Frankly, we find this outrageous. It is clear that the FDA, in crafting these revised QHCs, has chosen to ignore the recent precedent set in the green tea case, where the judge stated that the FDA-approved QHC “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”
We won’t let the FDA just ignore this legal ruling. We will insist that they live up to it and continue to take them to court as necessary. Even if progress is slow, we will make progress.
Why are we doing all this? Because we believe that American consumers have a right to know about scientific evidence that exists regarding the foods they eat or supplements they take. We believe that denying the right to free speech, simply because it falls under two government agencies’ jurisdictions, is both an attack on consumers and consumers’ health and is also unconstitutional.
These agencies keep demanding double-blind RCTs, but that is not an appropriate standard for foods or supplements. RCTs are impossibly expensive. Because natural supplements cannot be patented, the manufacturer could never charge enough to recoup their costs. This is why the Free Speech about Science Act (FSAS) is so terribly important.
If you have not done so already, please contact your congressional representative today and ask for his or her support on FSAS!

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Toxic Chemical Being Sold as a Health-Conscious Sweetener

Tue, 21 Feb 2012 22:00:45 +0000

Splenda Essentials pretend to be health-supporting, when in fact they seem to have more in common with pesticides than with sugar.

Sucralose, sold under the brand name Splenda, is simply chlorinated sugar; in chemical terms, it is a chlorocarbon. The idea behind this is that the body would no longer recognize it as sugar. But, as Johns Hopkins-trained physician and biochemist James Bowen, MD, points out, chlorine is “nature’s Doberman attack dog—a highly excitable, ferocious atomic element employed as a biocide in bleach, disinfectants, insecticide, WWI poison gas and hydrochloric acid.” Common chlorocarbons include chlordane and DDT, a product so harmful that it is now banned for agricultural use the world over.
Now Splenda is selling a product called Splenda Essentials. Different formulations contain B vitamins, antioxidants (vitamins C and E), or fiber. The marketing and advertising appear to be targeting health-conscious people who are interested in vitamins and nutrition—despite the fact that Splenda is highly toxic and has no place in a healthy diet.
Splenda’s advertising says the addition of B1, B5, and B6 “help support a healthy metabolism.” The antioxidant product “contains vitamin C and E, like those found in fruits and vegetables,” while the fiber product is touted as containing “one gram of healthy fiber.” It is worth noting that the regular Splenda product already contains fiber—the powdery dextrose and/or maltodextrin that forms the carrier for the sweetener—but only between 0.5 and 1.0 grams of it. For the fiber product, they bumped it up an even 1.0 grams. Whoopee.
For the vitamins, Splenda has added 20% of the recommended daily allowance; for the fiber, they’ve added 0.03% of the RDA. But let’s compare those amounts with the recommendations from the late scientist, researcher, and physician Dr. Emanuel Cheraskin of the International Academy of Science:

	B1	B5	B6	C	E	Fiber
RDA	1.2 mg	5 mg	15 mg	85 mg	15 mg (22.35 IU)	32 mg
Amount per packet	0.24 mg	1 mg	3 mg	17 mg	4.5 IU	1 mg
Cheraskin	25 mg	100–200 mg	25 mg	1,000 mg	450 IU

With the minute amounts of nutrients per packet, one would need to be consuming unconscionable numbers of packets to make any impact at all on one’s health—that is, provided one weren’t also consuming the sucralose itself! As we noted last year, Splenda alters the microflora in the intestine and “exerts numerous adverse effects,” according to a Duke University study, including an increase in body weight (not quite what a “diet aid” is supposed to do!) and an elevation of liver enzymes, which hurts the bioavailability of nutrients.
In “The Lethal Science of Splenda, a Poisonous Chlorocarbon,” Dr. Bowen says that “any chlorocarbons not directly excreted from the body intact can cause immense damage to the processes of human metabolism and, eventually, our internal organs. The liver is a detoxification organ which deals with ingested poisons. Chlorocarbons damage the hepatocytes, the liver’s metabolic cells, and destroy them.”
Dr. Bowen notes that the high solvency of chlorocarbons like Splenda attacks the human nervous system and can produce cancer, birth defects, and immune system destruction. In test animals, Splenda produced swollen livers (as do all chlorocarbon poisons), calcified their kidneys, shrunk their thymus glands (the biological seat of immunity) and produced liver inflammation.
Our colleagues at ANH-Europe point out other adverse effects in animals as a result of sucralose ingestion: DNA damage in gastrointestinal organs, increase in the number of normal cells in the surface tissue of the kidney, hemorrhagic degeneration of the adrenal cortex (which regulates carbohydrate and fat metabolism, salt, and water balance), incidence of cataracts, marked gastrointestinal disturbance, and deaths in pregnant rabbits and aborted rabbit fetuses. Splenda’s adverse effects in humans include headaches and migraines and a long list of consumer-reported side effects including skin rashes/flushing, panic-like agitation, dizziness and numbness, diarrhea, swelling, muscle aches, intestinal cramping, bladder issues, and stomach pain.
Splenda has replaced aspartame as the number one artificial sweetener in foods and beverages; aspartame’s popularity declined after the public learned that that it is both a neurotoxin and an underlying cause of chronic illness. As Dr. Bowen warns, “We should not be fooled again into accepting the safety of a toxic chemical on the blessing of the FDA and saturation advertising. In terms of potential long-term human toxicity we should regard sucralose with its chemical cousin DDT, the insecticide now outlawed because of its horrendous long term toxicities at even minute trace levels in human, avian, and mammalian tissues.”
Splenda’s online marketing includes a series of YouTube videos called Splenda Essential Choices for Healthy Living, which features an ADA-certified Registered Dietitian giving people health advice—though we might call it “natural health lite”—including prominent endorsements of Splenda Essentials.
ANH-USA is filing a citizen petition with the Federal Trade Commission regarding Splenda’s deceptive advertising. Their marketing clearly targets health-conscious people interested in nutrition, while trying to pass off a toxic chemical as healthy.

The post Toxic Chemical Being Sold as a Health-Conscious Sweetener first appeared on Alliance for Natural Health USA - Protecting Natural Health.

Why Selling Natural Products is Such a Dangerous Business

Tue, 13 Sep 2011 20:40:29 +0000

Part Two of our recent article on the laws threatening integrative doctors and integrative medicine—one of our most popular articles last month!

(If you’d like to read Part One, our discussion of the legal problems threatening physicians who use integrative medicine, click here.)

Federal Law for Sellers of Food, Supplements, and Medical Devices

The Federal Food, Drug, and Cosmetic Act (FD&C) gives authority to the FDA to regulate interstate commerce of supplements, drugs, and devices. According to the FD&C, by definition, only drugs can claim to cure, prevent, mitigate, or treat a disease [section 201(g)]. Nothing else may make that claim—certainly not a food or supplement.

To legally market a drug (that is, any substance that can claim to cure, prevent, mitigate, or treat a disease), it must go through the lengthy and expensive FDA drug approval process. Any violation—that is, any sale of a “drug” that is not FDA-approved—can lead to seizure of the product, injunctions against its sale and distribution, and criminal penalties, including imprisonment, for the manufacturer.

And as we have noted many times before, if a substance is natural, it is not patentable, and companies can only recoup their huge investment (as much as a billion on average, although estimates vary) in FDA approval if they can make it up through the high prices that patent protection makes possible. Therefore, natural products in supplement form will never be able to claim to treat disease, including cancer [section 201(ff)].

Why Only Patentable Drugs Are Considered “Safe”

The FDA’s control over patients’ access to cancer drugs was challenged in a 1979 lawsuit, United States v. Rutherford. Terminally ill cancer patients sued to stop the FDA from preventing the interstate shipment and sale of Laetrile—a modified form of amygdalin, a naturally occurring substance found in apricot pits as well as in other plants. The Supreme Court determined that the FD&C “makes no express exceptions for drugs used by the terminally ill…Exceptions to clearly delineated statutes will be implied only where essential to prevent ‘absurd results’ or consequences obviously at variance with the policy of the enactment as a whole.”

The Court supported FDA’s position that terminally ill cancer patients must be ensured therapeutic gain, which is only “guaranteed” by FDA approval. What this means in effect is that only non-natural and therefore patentable drugs which can be brought through the FDA process are “safe” enough to be used, even though natural remedies, which our bodies have evolved with, are generally safer or at least more predictable in their effects.

The further irony here, of course, is that the FDA has often approved drugs that are outrageously unsafe, causing so many deaths that they are subsequently pulled from the market and banned. The US National Poison Data System’s latest report records only a single death concurrent with supplement use—an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. On the other hand, it shows that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% of fatalities—with 122 deaths attributed just to acetaminophen—an over-the-counter pain reliever sold under the brand name Tylenol.

Even though supplements cannot claim to prevent or treat disease, everyone knows that they may often be used for this purpose, either by consumers who have studied the scientific research, or by doctors themselves.

FTC Currently Violating the Law

The Federal Trade Commission code contains both a general prohibition of unfair or deceptive acts or practices affecting commerce [15 USC 45(s)] and a provision specifically prohibiting false or deceptive advertising of foods, drugs, devices, or cosmetics [15 USC 52]. In other words, the FTC has authority to stop false advertising of drugs and supplements as well as unconventional treatments it deems to be false medical cures—including cancer treatments.

Unfortunately, as we reported this past April, the FTC has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. The FTC is now requiring two random-controlled human trials for any health-related claim—even so-called structure/function claims, which are permitted under the Dietary Supplement Health and Education Act of 1994 (DSHEA) without such trials. In response, ANH-USA and our co-plaintiffs, Durk Pearson and Sandy Shaw, filed a Petition for Rulemaking before the FTC. This petition, if denied, will lead to a litigation phase.

Often the FDA and the FTC work together to target supplement and food companies, which is precisely why the Free Speech About Science Act is so important. There are also federal criminal statutes that might affect the marketing and advertising of unconventional cancer treatments, like the wire fraud statute, which prohibits use of telephone, radio, or television to make “false representations for products and services,” and the federal smuggling statute.

Given all these legal risks, producers of natural food, supplements, and devices deserve our thanks.

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