FDA has recently challenged the use of wooden planks (shelving) to age certain cheeses, a practice that has been going on for centuries. The Agency is concerned that wood absorbs and retains certain bacteria, such as listeria, that can sicken cheese consumers. Many domestic and imported cheeses are aged on wood shelves, such as parmesan and certain blue varieties.
Foodborne illness affects approximately forty-eight million Americans per year, according to recent data from the CDC. Consumers have heard news stories warning of nationwide food recalls. What additional steps can be taken to ensure food safety? The FDA Food Safety Modernization Act was designed to address that question. Included in Section 211 of that Act are new provisions related to a Reportable Food Registry system (RFR) for increasing the speed of investigation and action to address foodborne illness (this is separate from FDA’s recall program). Although FDA already had a public meeting in June 2011, the agency only received three comments, and believes it needs further input. So, on March 26, 2014, FDA published an advance notice of proposed rulemaking (ANPR) seeking public comment through June 9, 2014.
The proposal may require submission to FDA by a responsible party through the RFR of consumer-oriented information regarding a reportable food (information necessary to accurately identify whether a consumer possesses a reportable food) within twenty-four hours of discovery of an event. A “responsible party” is the person that submits a food facility registration related to the reportable food. A public health official may also submit a report, but not consumers. FDA would assess the information and publish a standardized one-page summary on its website for purposes of notifying consumers. FDA may require the responsible party to notify or provide contact information for upstream and downstream supply chain entities. Grocery stores that sold the reportable food would be required to prominently display that information within twenty-four hours of the FDA’s website posting, and for a period of 14 days. FDA is required to develop a list of acceptable conspicuous locations and manners for grocery stores to post the information.
“Consumer-oriented information” would include a description of the reportable food, production identification codes for the reportable food, contact information, and any other information for the consumer to identify the reportable food. “Reportable foods” are those “for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals.” The new provisions will also not apply to fruits and vegetables.
Whether a beverage or a dietary supplement, liquid products are marketed more than ever before–now containing a wider array of ingredients, for many more intended uses and including traditional food substances, but at levels far exceeding previously used amounts. So how does one know if a liquid product is a beverage or a dietary supplement? And what regulations must be followed? To answer those questions, FDA has issued nonbinding recommendations in two new guidances this month: Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. FDA hopes that these guidances will help the industry avoid misbranding with inconsistent product category labeling and adulteration for failure to meet the proper regulations.
When distinguishing between beverages and dietary supplements, as a general rule, dietary supplements are meant to supplement the diet, and beverages are for quenching thirst and providing fluid, nutritive value, taste or aroma. FDA’s Guidance sets out the following factors to consider in distinguishing between the two types of liquid products: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations and directions for use, marketing practices, and composition of the liquid product. The Guidance provides examples of how the factors can come into play in a determination. It is likely that a combination of factors, not one, will be determinative of a product’s category. For example, even if the label of a liquid product contains a Supplement Facts Panel, it could still be considered a “beverage” if it also contains a statement that the product “refreshes,” or the product could be a “food” if the label contains a picture of the liquid being poured onto a salad. The product name could also be determinative that a product is likely a “beverage”, if the product name contains conventional terms for beverages, like “drink”, “soda”, “orange juice”, “iced tea”, “bottled water”, or “coffee”. The product packaging is another determinant and, if the packaging is reclosable, is shaped similar to a common beverage package, or contains a single serving, then it is likely a “beverage”. The serving size or recommended daily intake may also indicate which category a liquid product falls under. For example, if the product is intended to be consumed all at once or contains a significant part of the entire daily drinking fluid intake for the average person then it is likely a “beverage”. Interestingly, marketing practices, another factor, such as metatags for “sodas,” “juices” or “beverages,” or paying for store shelf placement with other beverages could be determinative of a “beverage”. But the product is not necessarily a “beverage” if the marketing says the product should be taken with a meal, since dietary supplements are often recommended for use along with a meal. Finally, the composition of a liquid product may be determinative, although there is a lot of overlap now with both categories containing amino acids, proteins, and vitamins. Similarly, merely adding a dietary ingredient does not make a product a “dietary supplement”.
FDA has tentatively found that partially hydrogenated oils (“PHOs”), the primary dietary source of trans fatty acids, are no longer generally regarded as safe (“GRAS”). While PHOs are used in a number of food products (e.g. margarine, shortening, and baked goods), they have been linked to significant health risks, such as coronary heart disease. FDA’s tentative determination that PHOs are no longer GRAS means that PHOs would now be classified as “food additives,” subject to Section 409 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (21 U.S.C. 348). FDA does not allow food manufacturers to sell food additives, directly or indirectly, without prior approval for us by FDA.
The FD&C Act defines a “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food….” 21 U.S.C. 321(s). Except that GRAS substances are not considered food additives. A substance is GRAS if it is generally recognized to be safe under the conditions of its proposed use “among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures.” In addition, if the substance had been used in food before January 1, 1958, it could be considered GRAS based on experience form its “common use” in food. However, even common use in food cannot overcome new evidence demonstrating that a consensus no longer exists that the substance is safe.
While some GRAS substances are listed in the regulations, there is no comprehensive list of GRAS substances. With the passage of the Food Additives Amendment to the FD&C Act in 1958, FDA established a list of GRAS substances. And in 1972, FDA instituted a notice-and-rulemaking procedure for affirming certain substances as GRAS. However, in 1997, FDA instituted a voluntary notification program for GRAS substances, which does not require notice-and-comment rulemaking. Thus, in many cases, food manufacturers and users have been responsible for determining whether substances are GRAS in light of the views of experts. For example, partially hydrogenated soybean oil and partially hydrogenated cottonseed oil were considered GRAS based on common use prior to 1958, but are not listed as GRAS in any FDA regulation.
On September 11, 2013, FDA issued a draft Guidance entitled, “Recommendations for Preparation and Submission of Animal Food Additive Petitions.” This Guidance provides the Center for Veterinary Medicine’s (“CVM’s”) recommendations regarding information to be included in food additive petitions (“FAPs”) for animal foods. FDA regulates food and substances added to food, some of which are “food additives.”
A food additive is:
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of or otherwise affecting the characteristics of any food, unless the substance in Generally Recognized as Safe (GRAS) among qualified experts under the conditions of its intended use, or meets one of the other exemptions to the food additive definition (e.g., new animal drug, color additive, etc.).
To use a food additive in animal food, the additive must first be approved by FDA for such use. The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) sets forth a petition process to ensure that the use of a food additive in animal food is safe. The process is set forth in section 409 of the FD&C Act. Prior to initiating a petition, applicants should verify whether the additive is already approved, i.e., there is a regulation in place for the intended use of the substance in animal food.
On September 10, 2013, the Food and Drug Law Institute (“FDLI”) hosted a conference, “Safeguarding the Functional Food and Dietary Ingredient Supply Chain“. The Conference concerned a variety of emerging requirements and compliance issues for functional foods and dietary ingredient or supplement manufacturers and distributors in view of the FDA Food Safety Modernization Act (“FSMA”). Signed into law on January 4, 2011, FSMA has been called “the most sweeping reform of our food safety laws in more than 70 years.” Among other things, FSMA shifts the focus from responding to contamination to preventing it to ensure the U.S. food supply is safe.
The Conference Keynote, Daniel Fabricant, Ph.D., FDA’s Director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Office of Foods and Veterinary Medicine, remained throughout the program and provided insights regarding FDA’s view on “functional foods” and dietary ingredients. First off, FDA has not officially recognized that there are “functional foods”, despite understanding that many people are self-treating based on information gleaned on the Internet or elsewhere with the hopes to either prevent or mitigate potential or current health issues. According to Fabricant, while dietary supplements may make certain health (structure/function) claims with adequate scientific evidence, FDA does not authorize foods to make health claims; instead, FDA considers foods to make statements about taste, aroma, and nutritive values.
In Fabricant’s view, it is not clear where industry should go when looking for guidance on functional foods, which are viewed by industry as foods with legal structure/function claims. FDA is concerned about the potential for harm: (1) invisible (hard to detect), (2) conscious (deliberately tainted), or (3) catastrophic (affects many people). Fabricant suggested that energy drinks, for example, have been suggested as a functional food, but many of these products include caffeine, which is a drug or conventional food. But the physical attributes of the product is not the primary determinant. Here, FDA is developing guidance to distinguish liquid dietary supplements from conventional, food-type beverages. What FDA has seen is that companies engage in “category hopping” to pick the category that where they best meet the requirements, but good manufacturing practices (“GMPs”) often remain an issue. And in FDA’s view, many products over rely on “bad” information rather than “competent and reliable scientific evidence.” Here, FDA looks whether a particular claim is substantiated– what is the meaning of claim, the relationship of scientific evidence to the claim, the quality of evidence, and the totality of evidence in view of the claim. The biggest “pitfall” Fabricant mentioned is an over-reliance on disease treatment studies and confusion regarding intended use.
On September 10, 2013, FLH’s Partner Brian J. Malkin will be attending the Food and Drug Law Institute’s (“FDLI”) Conference, “Safeguarding the Functional Food and Dietary Ingredient Supply Chain“. The Conference will address a variety of compliance issues and the emerging requirements for functional foods and dietary supplement manufacturers and distributors in view of the FDA Food Safety Modernization Act (“FSMA”). FSMA has been called “the most sweeping reform of our food safety laws in more than 70 years” and was signed into law by President Obama on January 4, 2011. FSMA shifts the focus from responding to contamination to preventing it to ensure the U.S. food supply is safe.
Conference attendees will hear from top FDA officials. For example, the Conference features a Keynote Address from the Director of FDA’s Division of Dietary Supplement Programs, Daniel Fabricant, Ph.D. In addition, industry experts will provide insight on how FDA may implement FSMA’s supplier verification requirements of the Food Safety Modernization Act (FSMA). In particular manufactures will gain a greater understanding of what regulatory requirements can be expected in the coming months by discussing the key regulatory provisions of supply chain safety, the differing definitions for ingredients used in functional foods versus ingredients used in dietary supplements, and by analyzing trends in supply chain quality testing.
New York City has been attempting to take on various health problems by thinking locally by banning or discouraging unhealthy activities such as banning smoking in public places or by disclosing information about trans fats or high calorie foods to discourage their consumption. More recently, New York City proposed a prohibition on certain sugary beverages over 16 ounces in establishments regulated by the city’s health department, including food chains such as Subway and Dunkin’ Donuts (but not establishments not regulated by the city’s health department, such as 7-Eleven and grocery stores). The New York State Supreme Court Appellate Division Panel agreed with a lower court decision from March 2013 finding the ban unconstitutional.
Associate Justice Dianne T. Renwick wrote in an unanimous four-judge panel decision:
The regulatory scheme is not an all-encompassing regulation . . . It does not apply to all sugary beverages. The Board of Health’s explanations for these exemptions do not convince us that the limitations are based solely on health-related concerns.”
Renwick’s sentiments echoed what was said in the lower court by Judge Milton Tingling who wrote in his decision that the proposed regulation was “fraught with arbitrary and capricious consequences” and “loopholes in this rule effectively defeat the state purpose of the rule.”
Earlier this week, the U.S. Supreme Court denied GlaxoSmithKline’s certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)’s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.
Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention “solely for uses reasonably related to the development and submission of information under [federal drug laws],” does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that “§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration.” Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)’s safe harbor and explained that Classen held that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”
As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK’s petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit’s Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court’s interpretation of the provision.
Adverse event reports submitted voluntarily by doctors and companies recently released by FDA state that the deaths of five people over the past three years may have been linked to drinking Monster Energy, an energy drink containing high levels of caffeine. The reports filed using the Center for Food Safety Adverse Event Reporting System spanned a period from 2004 to June 2012, but all of the deaths occurred in 2009 or later. An FDA spokesperson, Shelly Burgess, stated that energy drink manufacturers are responsible for investigating these accusations and that the FDA is investigating these cases, but has not established a causal link between the deaths and the drinks.
The reports were released through the Freedom of Information Act (“FOIA”) to the mother of a 14-year-old girl who recently died after drinking two 24-oz. Monster Energy drinks in a 24 hours period. The parents of the girl have recently brought survival and wrongful death actions against Monster Beverage Corporation (“Monster Beverage”), the manufacturer of Monster Energy, in the Superior Court of the State of California for the County of Riverside using these reports. According to the complaint filed on October 17, 2012, the two 24-oz cans of Monster Energy consumed by the girl contained 480 milligrams of caffeine or the equivalent amount of caffeine in fourteen 12-oz. cans of Coca-Cola. The girl’s autopsy and death certificate state the cause of death as “cardiac arrhythmia due to caffeine toxicity complicating mitral valve regurgitation in the setting of Ehlers-Danlos syndrome” according to the complaint. Ehlers-Danlos syndrome can affect the body’s connective tissue, including blood vessels.
The complaint further asserts that, in addition to caffeine, Monster Energy drinks contain guarana and taurine. Guarana contains caffeine and taurine effects cardiac muscles in a similar way compared to caffeine. Caffeine, guarana, and taurine have also been shown to work synergistically. The complaint also alleges that Monster Beverage “avoided meaningful regulation of its products” by FDA since it classified its drink as a “dietary supplement.” Monster Beverage has denied these allegations responding that “Monster is unaware of any fatality anywhere that has been caused by its drinks.”