spent brewing grains
This past spring, we highlighted a provision in the Food and Drug Administration’s (FDA) proposed implementation of the Food Safety and Modernization Act (FSMA) that would effectively stop brewers, distillers, and wine makers from sharing the byproducts of their production with farmers for use as animal feed. Such a practice has deep roots in the crafting of alcoholic beverages and is substantially beneficial to all parties involved. As we wrote previously:
Farmers have been procuring and feeding their livestock spent brewing grains and grapes for centuries. These livestock “happy hour” arrangements advance environmental sustainability, engender bonds among local businesses, and financially benefit both parties. Farmers get low-cost whole grain feed packed with fiber, protein, and, of particular importance to livestock in arid climates, moisture. Alcohol makers save millions by not having to landfill the by-products.
The proposal inspired quite an uproar from alcoholic beverage producers of all sizes, from nanobreweries to large distillers, as well as Members of Congress. The reaction inspired second-thinking at FDA, and we were hopeful that the agency would eventually reverse course on this proposal that protected nobody from nothing.
On September 29, FDA will formally publish in the Federal Register and seek comment on revisions to its 2013 Food for Animals proposed rule.
On pages 43-50 in the pre-publication PDF, FDA acknowledged that any hazards that might potentially arise from the production of spent grains and grape pomace could be addressed through compliance with the separate human food rules being promulgated to implement the FSMA. FDA did feel compelled to note in the Animal Food proposal, however, that once the alcohol production byproducts were “separated from the human food,” the facilities “would need to ensure that the animal food is not treated like trash or garbage.”
We must give FDA two cheers for considering the overwhelming public opposition to the spent grain provisions in the 2013 proposal and embracing a common-sense approach. Had the agency acknowledged that its original proposal was directly at odds with the explicit language of FSMA, we would have offered a third cheer.
FDA’s proposed Nutrition Facts format
The Food and Drug Administration’s (FDA) proposed addition of “added sugars” to the mandatory Nutrition Facts label on packaged food lacks scientific justification, is more likely to confuse than inform consumers, and will expose the agency to a constitutional challenge. So why is FDA pushing forward with this counterproductive idea?
In announcing proposed changes to the 20-year old “Nutrition Facts” label, FDA reminded us that the purpose of the ubiquitous label is to “help consumers make informed food choices and maintain healthy dietary practices.” The update ostensibly would provide, among other improvements, “greater understanding of nutrition science.” However, one of the update’s most highly touted additions—a new line item for “Added Sugars,” triple-indented under “Carbohydrates” and “Total Sugars”— thoroughly fails to achieve these stated goals and contradicts current nutrition science.
Uninformative. If the Nutrition Facts label exists to “help consumers to make informed food choices,” then shouldn’t FDA be certain that listing added sugars would in fact be helpful? The agency, though, acknowledges in its March 3 proposal that it is “not aware of any existing consumer research that has examined this topic.“
One public comment provided to FDA did offer consumer research, and the data thoroughly undercuts the “Added Sugars” proposal. The International Food Information Council (IFIC) Foundation conducted a consumer survey that conformed to OMB requirements for government research. The results revealed confusion among surveyed consumers over the meaning of “Added Sugars.” More than half of respondents believed that Added Sugars were different from the sugars included in “Total Sugars.” A substantial number believed that instead of being a part of the Total Sugars figure, Added Sugars should be added to Total Sugars. Consider, for instance, a bottle of sweetened iced tea, which is currently labeled to contain 22 grams of sugar per serving. None of the sugar is naturally occurring. If the proposed Nutrition Facts label is adopted in its entirety, consumers might look at the 22 grams of Total Sugars, and the 22 grams of Added Sugars, and conclude that the tea contains 44 grams per serving. In addition, the survey found that a majority of consumers felt that products listing added sugars contained more sugar than was actually present, a perception that would affect their purchasing decisions.
An agency whose mission is consumer protection must not mandate confusing or misleading label information. FDA should take heed of the IFIC Foundation research and do what it should have done from the start: study the issue before mandating that Added Sugars be listed. Continue reading
by Gail Javitt, Sidley Austin LLP*
The penchant of the Food and Drug Administration (FDA) to use “guidance” documents as a means to effectuate substantive regulatory change may have reached its zenith on July 31, 2014, when FDA’s Center for Devices and Radiological Health announced its intent to issue two new draft guidances. Those draft guidances would fundamentally alter the oversight of clinical laboratory testing in the United States, by regulating clinical laboratories as medical device manufacturers and the laboratory developed tests (LDTs) they perform as medical devices.
As mandated by Congress under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified the House and Senate committees of jurisdiction that the agency intended to issue draft guidance, and also unveiled advance copies of the guidance documents. These documents announce the agency’s “risk-based” framework for LDTs, which comprise essentially all laboratory testing that is not performed using an in vitro diagnostic test kit in accordance with a manufacturer’s instructions for use.
Under the proposed framework, all clinical laboratories that perform laboratory developed tests will, at a minimum, be required to register with FDA, list the LDTs they perform, and report “adverse events” to FDA. LDTs that FDA classifies as “high” or “moderate” risk will also need to obtain FDA premarket review and authorization. They will additionally be subject to quality system regulatory requirements for medical devices, although the agency has not yet explained how it plans to adapt these to the clinical laboratory context. Continue reading
Just below the fold in the print and digital versions of this morning’s Washington Post blares the headline “Food additives on the rise as FDA scrutiny wanes.” The story dutifully advances the perspective of professional activists that the Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) process for food additives is perilously broken. Food nanny organizations such as Center for Science in the Public Interest and the Natural Resources Defense Council have ramped up their attacks on GRAS over the past several years, assisted by a 2010 Government Accountability Office (GAO) report calling for changes to the process.
As explained in a Washington Legal Foundation Legal Backgrounder by Hyman, Phelps & McNamara attorneys Roberto Carvajal and Nisha Shah, the GRAS process dates back to 1958, when Congress determined that certain uses of substances in foods that were generally recognized as safe need not go through formal FDA approval. For nearly four decades, FDA applied that exception very narrowly, but the Clinton-era agency leadership altered that interpretation in 1997. They concluded that narrow application of the GRAS exception deeply strained agency resources and chilled food industry innovation. The agency’s new approach permitted food processors to self-report new uses of certain substances and provide FDA with the science supporting the GRAS conclusion. In response to the critical 2010 GAO report, the agency acknowledged that while the GRAS process could be improved, “FDA believes that the GRAS concept has continuing utility as a practical tool for distinguishing between substances and new uses of substances that merit a full pre-market safety evaluation by FDA and those that do not.”
FDA’s resolve on the GRAS process seems to be weakening, however. The Post article features a troubling front-page quote from FDA’s Deputy Commissioner Michael Taylor: “We simply do not have the information to vouch for the safety of many of these chemicals.” He goes on to proclaim later in the article, “We aren’t saying we have a public health crisis.” But of course Deputy Commissioner Taylor understands that when FDA uses the term “public health crisis,” even when denying the existence of one, it sounds alarm bells. FDA’s latest statements could be setting the stage for regulatory action against such common, widely-used ingredients as caffeine and sodium, which the agency has long considered GRAS.
For those who might be interested in learning more about the GRAS process from a far different perspective than the Washington Post provided today, watch WLF’s free July 10 Web Seminar, The Future of FDA’s “GRAS” Designation in an Era of Increased Scrutiny. The Powerpoint presentation utilized by our speakers, Keller and Heckman LLP’s Melvin Drozen and Evangelia Pelonis, is available here.
by Samantha J. Malnar, a 2014 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.
A “call to action” this week from the Surgeon General of the United States reports that nearly 5 million people are treated with skin cancer in America each year. Of those treated yearly, 9,000 die from melanoma. The report explains that skin cancer is the most preventable form of cancer, and urges steps government and individuals can take to reduce the risks. Regretfully, the Surgeon General failed to spotlight the role government regulation has played in increasing the risk of skin cancer. Thanks to federal regulators’ unconscionably slow action on reviewing and approving new formulas, Americans can only get the best available sunscreens overseas.
It has been fifteen years since the Food and Drug Administration (FDA) has approved a new sunscreen ingredient, even though there are eight applications pending—some dating back to 2002. Notably, the last application was submitted in 2009, which suggests that the agency’s failure to act has deterred companies from investing in the United States market. As the former head of the American Academy of Dermatologists told The Washington Post, “These sunscreens are being used by tens of millions of people every weekend in Europe, and we’re not seeing anything bad happening.” In fact, in European countries, sunscreen manufacturers can choose from twenty-seven chemicals, seven of which were specifically designed to protect against UVA rays.
As of right now—as was the case fifteen years ago—sunscreen manufacturers in the U.S. are limited to the use of seventeen sunscreen ingredients, only three of which protect against UVA rays. UVA rays are especially dangerous because they deeply penetrate the skin, normally damaging it without showing any immediate signs or symptoms of the damage, such as sunburn. Continue reading
In order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.
FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.
Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol. Continue reading
By Eric G. Lasker, Hollingsworth LLP (Mr. Lasker argued McKay on behalf of Novartis Pharmaceuticals Corporation in the Fifth Circuit)
Debates over whether—and in which circumstances—Food and Drug Administration (FDA) approval of prescription drugs and medical devices should preempt State law have been in the forefront of Supreme Court jurisprudence and Congressional action for over a decade. However, when a State itself concludes that FDA approval is the correct standard for state law liability, one would think that would end the debate, right? Well, yes, but not without a few tantrums along the way.
Texas’s FDA Defense. In 2003, Texas enacted a tort reform statute which protects pharmaceutical products manufacturers (subject to specifically defined exceptions) from liability based upon a warning or other information that was approved by the FDA. Tex. Civ. Prac. & Rem. Code § 82.007(a). Texas took this step based upon the Legislature’s informed view that the State was facing an environment of excessive litigation that had caused a crisis in access to healthcare. Of course, the plaintiffs’ bar argued strenuously to the contrary. Many of their brethren appeared in hearings before the Texas Legislature; they accused the Legislature of caving to “Big Pharma” and argued that the FDA couldn’t be trusted to review drug safety. But the Legislature disagreed, and FDA-approval was adopted as the presumptive standard of care in pharmaceutical products liability cases in Texas.
Plaintiffs’ Bar’s Efforts to Judicially Nullify § 82.007(a). What was the response? Predictable. The plaintiffs’ bar turned to the courts to undo what the Legislature had done. They argued that § 82.007(a) should be read narrowly to apply only to expressly-labeled “failure to warn” claims, ignoring the fact that in pharmaceutical litigation, the adequacy of warnings is key regardless of the legal theory of liability. They argued that a jury should decide whether § 82.007(a) even applied, seeking a threshold whereby the jury could decide that the manufacturer secured regulatory approval through fraud on the FDA—despite clear U.S. Supreme Court authority that such a state law jury inquiry was preempted by federal law. They argued that the entire statute should be stricken if their interpretation of the fraud-on-the-FDA exception to § 82.007(a) was not accepted.
Thus far, each of these arguments has been rejected. As a result, one Texas plaintiff recently took a step that many Texans would consider a sacrilege: he asked the court to treat him as a Californian instead! The case is McKay v. Novartis Pharmaceuticals Corp., and on May 27, 2014, the United States Court of Appeals for the Fifth Circuit rejected this desperate gambit as well. McKay v. Novartis Pharm. Corp., __ F.3d __, No. 13-50404, 2014 WL 2198544 (5th Cir. May 27, 2014). Continue reading