The American Olive Oil Producers Association has filed a citizen petition urging the U.S. Food and Drug Administration (FDA) to "promulgate regulations for the standards of identity for olive oil and olive-pomace oil." The lack of standard of identity has led to "widespread mislabeling of grades, adulteration, consumer mistrust, and unfair and unethical industry business practices," the petition asserts, and the "continued absence of an enforceable standard is harming consumers. Off the shelf product testing demonstrates that U.S. consumers are frequently misled by mislabeling of grades and marketing tactics that leave them unable to differentiate between high quality extra virgin olive oil and low-quality, old or rancid oils, as well as cheap by-products that are chemically and mechanically refined and colored to resemble olive oil." The petition urges FDA to regulate "various grades of olive oil"—"extra virgin olive oil, virgin olive oil, olive oil composed refined oils"—to "promote honesty and…
Category Archives Food and Drug Administration
Reps. Roger Marshall (R-Kan.) and Anthony Brindisi (D-N.Y.) have introduced the Real Marketing Edible Artificials Truthfully (MEAT) Act, which would "codify the definition of beef for labeling purposes, reinforce existing misbranding provisions to eliminate consumer confusion, and enhance enforcement measures available to the [U.S. Department of Agriculture] if the [Food and Drug Administration] fails to take appropriate action," according to Marshall's press release. "The lack of any Federal definition of 'beef' or 'beef products' for the purposes of meat food product labeling has led some to begin marketing imitation products as meat or beef, creating the opportunity for marketplace confusion and consumer fraud that Congress originally charged the various Federal food regulatory agencies with the duty to prevent," the bill's text states. "Imitation products labeled as beef or as beef products create confusion in the marketplace. These products are in direct violation of the 'Congressional Findings and Declaration of Policy'…
The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have announced a joint warning letter sent to Rooted Apothecary LLC focused on the potential benefits that the company claimed its cannabidiol (CBD) products could provide. "The Agency continues to be concerned about the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA as is required by law and to protect the public health," the letter states. "There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD. Without this information, we are unable to ensure that these products will not cause harm to people who use them." The agencies warn that Rooted Apothecary is marketing unapproved drugs because it advertises its CBD-infused products as helping to diagnose, cure, mitigate, treat or prevent a number…
The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a dietary supplement. “This product is labeled as a dietary supplement; however, it cannot be a dietary supplement because it does not meet the definition of a dietary supplement,” the letter stated. “Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved [], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available…
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) announced a number of developments in their work on organic food, poultry and food safety. FDA released an update on the implementation of the Food Safety Modernization Act (FSMA), announcing it will track outcomes for FSMA rules for inspections and recalls via the Food Safety Dashboard. One metric the agency will track is how quickly a company issues a public notice for a Class 1 recall for human and animal food. FDA has also released guidance on recall plans for its multipart guidance on “how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.’” USDA updated the National Poultry Improvement Plan (NPIP) Program Standards to incorporate proposed changes published in April 2019, including the amendment of the testing…
The U.S. Food and Drug Administration has released guidance on the use of "medically important antimicrobials" in "food-producing animals." The guidance describes a voluntary process that "will help ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses." The agency will accept comments on the guidance until December 24, 2019.
A group of U.S. lawmakers, led by Reps. Chellie Pingree (D-Maine) and James Comer (R-Ky.), have urged the U.S. Food and Drug Administration to "quickly adopt a policy of enforcement discretion and to consider issuing an interim final rule to regulate [cannabidiol (CBD)] as a dietary supplement and food additive while simultaneously moving forward with a robust framework for evaluating the safety and accurate labeling of these products." The letter stated that the agency's "current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry. We are discouraged by FDA's estimation that a rulemaking process could span 3 to 5 years. We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors." In the U.S. Senate, Majority Leader Mitch McConnell (R-Ky.) reportedly took a different path in an effort to…
The U.S. Food and Drug Administration (FDA) has announced "A New Era of Smarter Food Safety," a public meeting "to get input from a broad cross-section of stakeholders on a modern approach the Agency is taking to strengthen its protection of the food supply." The meeting, which will be held October 21, 2019, is intended to "foster a dialogue with our domestic and international regulatory and public health partners, industry, consumers, academia, and others," and input will "be used to shape an FDA Blueprint for a New Era of Smarter Food Safety."
Denmark has reportedly passed a law that will ban per- and polyfluoroalkyl substances (PFAS) from cardboard and paper used for food packaging. "These substances represent such a health problem that we can no longer wait for the EU," Denmark's food minister is quoted as saying. Recycled paper may continue to be used if the PFAS compounds are separated from food with a barrier. PFAS compounds have come under scrutiny in both the United States and Europe as agencies research the effects of consuming the substances.
The U.S. Government Accountability Office (GAO) has conducted a study on how "use by" and "best by" dates on food products could be improved to reduce food waste. The agency examined actions by the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) and concluded with the recommendation that "USDA and FDA develop a mechanism to facilitate coordination with relevant nonfederal stakeholders on actions related to date labels," according to the agency. "USDA and FDA agreed with our recommendation and are planning actions to implement the recommendation."
