Tag Archives: FDA

Labelling It Healthy

What does the word “healthy” mean? The word is almost ubiquitous and is on every food, drink, or clothing label. However, there is little consensus on what the word “healthy” actually means. Does “healthy” mean low fat, low sugar, and low salt? While the word will likely still be used to describe a list full of foods and drinks, the Food and Drug Administration (FDA) is planning to create some clarity and redefine the word. FDA published a Federal Register (FR) notice announcing that the agency will be receiving information and comments on the use of the term “healthy” in the labeling of human food products. Currently, the FDA defines the term “healthy” when used as an implied nutrient content claim in labeling human food products at 21 C.F.R. §101.65(d)(2).

The FR notice comes a year after the FDA’s Center for Food Safety and Nutrition (CFSAN) issued a Warning Letter to KIND LLC, a producer of ‘Kind’ bars and other fruit and nut snacks, because the labels and labeling of KIND’s nutrition bars bore a variety of nutrient content claims, including “healthy,” but the products did not meet the requirements to make such claims.  KIND LLC subsequently sent a citizen petition to the FDA Commissioner requesting that the FDA update the FDA’s existing requirements related to food labeling to become consistent with current federal dietary guidance as set forth in the 2010 Dietary Guidelines for Americans and with the latest scientific evidence discussed in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (2015 DGAC Report).

As stated in KIND LLC’s letter to the FDA, the FDA’s current regulatory approach for food labelling is inconsistent with the DGAC recommendations. With obesity rates in the United States continually increasing at alarming rates, educating consumers about how to carry out a “healthful” diet is essential to public health. KIND LLC requested in the letter that the FDA take a holistic approach when reviewing the healthfulness of foods, instead of identifying and demonizing one food ingredient or nutrient.

The health label on packaging is an easy, but possibly misleading, tool that food companies can use to help educate consumers and give them easily accessible information about the food that they choose. A food may be low in salt, sugar and/or fat, but it doesn’t mean that it has the nutrients to create a healthful diet, which is why it is so important for the FDA to properly address this issue. It is likely that there will be an increase in regulation or scrutiny around food labels in order to create a more transparent food system, as well as attempt to stifle the upward trend of obesity.

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The End of Antibiotics?

Antibiotic resistance is upon us and affects both human and animal health. In a May 2016 report commissioned by United Kingdom (UK) Prime Minister David Cameron, Jim O’Neil, economist most widely known for coining the term BRICs for the emerging economies of Brazil, Russia, India and China and Commercial Secretary to Her Majesty’s Treasury in the UK, pointed out that 700,000 people each year die from bacterial infections that do not respond to antibiotics, and even more recently a new National Academy of Medicine (NAM) paper, conducted by six experts, outlines the evidence that there is a connection between antibiotic use in food animals and antibiotic resistance in people.

For almost fifty years, antibiotics have been approved for use in animal agriculture and human medicine to treat illness, and they have had a remarkable impact on our ability to improve the health of humans and animals alike. However, there are real concerns about the overuse of antibiotics in human and animal medicine, specifically as it relates to the development of antibiotic-resistant strains of bacteria in the US and around the world. The use of antibiotics has been the center of discussion in the US, European Union (EU), and other public forums, such as the World Economic Forum (WEF). In September 2016, there will be a United Nations high-level meeting on antimicrobial resistance at the General Assembly in New York. Global leaders will meet to commit to leading the fight against antimicrobial resistance. The EU has even proposed to include an article on Anti-Microbial Resistance within the SPS Chapter of the Trans-Atlantic Trade and Investment Partnership (TTIP), a trade agreement between the US and EU representing more than forty percent of global trade, addressing steps to mitigate resistance.

In recent years, the animal agriculture industry has placed a high importance on antibiotic stewardship to ensure these critical drugs continue to be effective at fighting bacterial diseases. The Food and Drug Administration (FDA) has issued guidance on the use of antibiotics in food-producing animals, with the goal to phase out the use of antibiotics for growth promotion. All of the affected drug sponsors have committed in writing to making the changes described in the guidance by the end of 2016. Additionally, the FDA wants to ensure the judicious use of antibiotics when used to treat and prevent animal diseases by requiring that antibiotics be administered under the supervision of a veterinarian.

Even with the changes made by the FDA and industry, there is a call to introduce legislation that would more stringently regulate the use of antibiotics in animal agriculture and allow only the use of antibiotics to treat illnesses and not for prevention. California passed the first law in the nation in October 2015 that will require a veterinarian’s prescription for therapeutic antibiotic uses in livestock, ban other uses (including low-dosage levels used to prevent diseases), and require that data be collected on antibiotic use. With the issue on the global stage, it is possible that we will see more advances in both state and federal legislatures to regulate the use of antibiotics in either animal or human health.

 

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