Fracking Fluid Used to Irrigate Organic Crops

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We represent Alliance for Natural Health USA (“ANH-USA”), which questions, inter alia, the validity of using the amount of time it takes for a product to disintegrate in water as a measure of quality when the stomach does not use water to digest products. ANH-USA is concerned that CL employs questionable methods to evaluate products and is acting out of financial self-interest while proclaiming that its “mission is to help consumer and health professionals identify high quality products” [emphasis in original].
A responsible public interest organization dedicated to ensuring quality in the market should have no problem accounting for its methods. On behalf of ANH-USA, we therefore pose the following questions to you:
1. Is it true that if a company does not pay to have a product tested through CL’s Quality Certification Program, it risks having that product tested through CL’s Product Reviews? And, is it true that if a product fails a Product Review, its failure will be publicized in CL’s member reports?
2. Is it true that if a company pays to have a product tested through CL’s Quality Certification Program and its product fails, those results will be hidden from CL’s member reports on the grounds that those tests are “proprietary to the manufacturer”?
3. How does withholding information from the public about failing products “help consumers and professionals identify high quality products”?
4. What selection criteria do you employ to choose a product for a Product Review? Please also explain in detail how you use survey results to select products. If some products are chosen at random, please explain the randomization process.
5. Prior to finalizing the list of products that you will test under a Product Review, do you notify companies that their products are under consideration for inclusion, and, if so, do you provide them an opportunity to have their products tested through CL’s Quality Certification Program instead?
6. How does the price for product testing through CL’s Quality Certification Program compare to the price of product testing through a third-party laboratory that does not release Product Reviews to paying members? Is it higher?
7. On CL’s website, www.consumerlab.com, you acknowledge that “[t]he FDA’s Good Manufacturing Practices (‘GMPs’) for dietary supplements allow each manufacturer to determine the quality standards and analytical methods it uses to evaluate the quality of its products.” Nevertheless, you claim that even if a product complies with GMPs, it can still be of low quality. For example, you state that “[s]ome choose to use less specific standards and/or lenient test methods that can make a low quality product appear to be high quality.”
You further claim that your standards are better, stating: “We adopt the most meaningful and strict standards based on the latest international research and recommendations.” What evidence can you provide to demonstrate that your quality criteria/standards and tests are generally accepted in the scientific community as sufficient to determine definitively a product’s quality?
Further, what evidence can you provide that your tests are appropriate for each product that you evaluate, and how do you, or the laboratories that you use, account for confounding factors, if at all, such as ingredients that either mask or magnify test results?
8. Which laboratories do you use to test products and what evidence do you possess that their testing methods and results are competent, reliable, and reproducible?
We look forward to receiving your prompt response within 30 days after the date of this letter. ANH-USA intends to publish a copy of this letter within the next several months along with any response you send.

ConsumerLab has yet to respond to these concerns.
Action Alert! Write to your state’s attorney general and the Federal Trade Commission (FTC) and ask them to investigate the business practices of ConsumerLab.com. Please send your message immediately!

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• Current good manufacturing practices (cGMPs) for supplements could not be more stringent. Laws to guarantee safe products are already on the books, and it is up to the FDA to enforce those laws. FDA memos, retrieved through Freedom of Information Act requests, show that the agency has, at least in the past, deliberately refused to enforce laws in the hope that something would occur which was so bad that current supplement law would be abandoned in favor of a drug-type regulation scheme. If once in a great while some bad actors fail to meet current high standards, and the FDA fails to hold them accountable, this should not reflect on the entire industry. The FDA already has the power it needs, so passing more regulations would simply be redundant.
• The testing regimens which the supplement industry are held to under cGMPs are one reason that supplements have such a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all. It is also worth noting that AERs are not concrete evidence of supplements being a factor in an adverse event, but simply a possible correlation. By contrast, in 2008, there were 526,527 AERs from pharmaceuticals—488 times more than the number of supplement AERs. Our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
• Because cGMPs already cover the lion’s share of what the AG’s letter is asking for, what Mr. Schneiderman and the other AGs really seem to be after—as evidenced by their use of specific language like “safety and efficacy”—is a regulatory regime that would subject supplements to the same pre-approval process that pharmaceutical drugs must go through. An economic analysis ANH-USA conducted in response to a less-stringent regulatory proposal than the one Mr. Schneiderman seems to be asking for found that between 22,240 and 41,700 dietary supplements would disappear from the market as a result. This hurts consumers far more than it helps them.

Given these considerations, one wonders what is motivating Mr. Schneiderman and his coalition of AGs in the first place. Is he trying to curry favor with the drug industry, in the hope that this will help him finance future campaigns—for governor, perhaps? There will be a huge political upside for him if Congress decides to act. It will create a media frenzy, with the NY AG’s name headlining all the stories, without his having to make a viable case for his position—something he has so far been unable or unwilling to do—or explain how any of this benefits New York’s taxpayers.
The possibility exists, of course, that he is simply misinformed. This is disturbing, since his initial tests have been completely invalidated. With no safety violation and no evidence of fraud, the NY AG’s office might have withdrawn its case and issued a mea culpa. If the entire process was predicated on faulty data, which appears to be the case, the AG needs to explain how his office could have acted so rashly and with such gross incompetence. Instead—and without a scintilla of scientific evidence or a single public health violation—he has redoubled his attack.
One thing is certain: consumers must speak out in a clear voice to tell congressional leaders not to cave in to these specious demands and to preserve consumer access to important dietary supplements.
Action Alert! Send a message to the senators who received this letter and urge them to protect our access to quality supplements! Please send your message immediately!

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• Redbook was designed as a how-to guide to prove that food and color additives are safe for pre-approval. This is a troubling paradigm to impose on dietary supplements which, by law, are specifically not subject to FDA approval. Furthermore, the evidentiary standard for dietary ingredients (which includes supplements) is very different from the standard for food additives: dietary ingredients need to have a “reasonable expectation” of safety, whereas food additives must have a “reasonable certainty” of safety.
• The law says that supplements on the market before 1994 are “grandfathered” into the system—that is, they are considered safe by their history of long use by the public, and do not require FDA review. If supplements get subsumed into Redbook, would it mean grandfathered ingredients would have to prove their toxicological safety? This could endanger thousands of supplements because of what we call the “Catch-22” of drug economics.Drug companies can pay the huge sums for toxicological studies because they are working with non-natural, new-to-nature (and new-to-the-human-body) substances that can be patented and turned into huge money-makers. But who would spend that money on toxicological studies for natural supplements, knowing that anyone could produce and sell it with out a patent? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the agency’s bills. Besides, supplements were grandfathered initially because, according to Congress, they had such a long history of safety—so toxicology studies are, by definition, unnecessary.
• Including supplements in Redbook blurs the line between food additives and dietary ingredients—something Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) explicitly stopped Rep. Henry Waxman (D-CA) from doing legislatively when DSHEA was being crafted twenty years ago. As Sen. Hatch said when that landmark legislation was introduced, “For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors….[DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.”

The last time FDA attempted to overtly apply food additive standards to dietary supplements, the agency’s efforts were soundly rejected—dare we say ridiculed—by not one but two US circuit courts of appeals:

• In US v. Traco Labs, the Seventh Circuit stated that “the only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances.”
• In US v. Oakmont Investment Co., the First Circuit wrote, “The proposition that placing a single-ingredient food product into an inert capsule as a convenient method of ingestion converts that food into a food additive perverts the statutory text, undermines legislative intent, and defenestrates common sense. We cannot accept such anfractuous reasoning.”

In 2011, we wrote that FDA seemed to be determined to try the same tactics the agency used in 1994 when it tried to derail DSHEA—and here we go again. David Kessler, then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen.
Expanding Redbook to include nutritional supplements is, at any rate, premature, given that the next version of the NDI (new supplement) guidance has not yet been released. Any required toxicological and safety studies for NDI notification should be addressed after that release.
In addition, if both the NDI guidance and Redbook end up addressing safety data for dietary supplements, it will lead to massive industry confusion, which will ultimately choke innovation, raise costs, and limit access to supplements. This may be exactly what the FDA wants in order to shield drugs from competition.
Not surprisingly, Sens. Hatch and Harkin sent the FDA a letter expressing their concern about Redbook, noting that “DSHEA contained an essential exclusion of dietary ingredients from the statutory definition of food additives,” and that the NDI guidance for dietary ingredients should be handled quite separately from Redbook: “The statutory clarity between dietary ingredients and food additives necessitates that guidance documents be separately released for these two different types of ingredients.” They also note that if FDA moves forward in including dietary ingredients in food additive paradigm, it would require rulemaking.
ANH-USA is preparing formal comments and will submit them shortly. Action Alert! Tell the FDA that Redbook should not be expanded to include dietary ingredients, and that any safety assessments for dietary ingredients should be addressed strictly in the context of the NDI guidance. Send your message today!

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• There was Sen. Durbin’s dangerous attempt to attach an anti-supplement rider to a spending bill—the infamous Durbin Amendment. His rider would have required, among other provisions, that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. This is a slippery slope to a preapproval process or a ban on high-dose supplements. (You may recall that the IOM suggests 4000 IU of vitamin D as the upper limit for dosage, and says anything greater is dangerous! By contrast, the Vitamin D Council believes 10,000 IU is a safe on a daily basis, with temporarily higher doses to correct imbalances.)  Fortunately, grassroots activists like you sent 100,000 messages in less than twenty-four hours, and the amendment was quickly defeated. We took the opportunity to rebut some of the misinformation Durbin was spreading on the Senate floor.
• Rep. Henry Waxman slipped an anti-supplement provision into the Wall Street reform bill. Because of your messages to Congress, that provision was soundly rejected in an all night reconciliation meeting.
• There were sneak GMO provisions included in the farm bill. The final bill was flawed, but in the end we were able to get rid of three very dangerous provisions.
• The Monsanto Protection Act was attached as a rider to a budget bill in 2013. After it was discovered, Bloomberg, The New York Times, Politico—media of all political persuasions—ran searingly critical articles about the biotech rider despite messages pouring into Congress via our and others’ alerts. The Daily Show mocked Congress, which may have gotten more attention than all the articles. Facebook and Twitter were ablaze with people like you telling their friends and neighbors about the provision, and the outrage was even greater once the legislation was passed. We mounted a campaign to repeal the rider, and thanks to your activism, the controversial provision was removed from the next funding bill that was signed into law.

Please keep a watchful eye on your email inbox for the next few days. If we spot any riders, we will send out an emergency Action Alert and ask you to contact your legislators immediately.

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