The dispute over the meaning of meat- and dairy-related terms continued in 2019, with more states passing bans on the use of terms implying animal-derived products, such as "burger" or "milk," to describe plant-based products. Nebraska, Arizona and Washington considered bans, and Arkansas' ban was targeted with a challenge from Tofurky that has resulted in a temporary injunction preventing the state from enforcing the statute against the company. Similarly, Mississippi proposed amendments to its meat-defining law after a "vegan bacon" and "vegan chorizo" company argued that the law "harms society." A Missouri court, meanwhile, denied the Good Food Institute's and American Civil Liberties Union's motion for a preliminary injunction to enforce the state's meat-labeling statute. In addition, a bipartisan bill introduced in November, the Real MEAT Act, would define meat-related terms if the U.S. Department of Agriculture and Food and Drug Administration (FDA) "fail[] to take appropriate action." The issue…
Tag Archives FDA
The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in radiation oncology, reportedly promised to prioritize science, data and public health over political interests when directing the agency's policy.
The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol (CBD) products and other products containing ingredients derived from cannabis. The update clarified that FDA "is concerned that people may mistakenly believe that trying CBD 'can't hurt'" because the agency has "seen only limited data about CBD's safety and these data point to real risks that need to be considered." FDA warned that CBD may have potential to injure the liver, cause negative drug interactions and affect male reproductive health, safety risks the agency identified during its review for the drug form of CBD. FDA's update coincided with the release of several warning letters to CBD companies from the agency's Center for Drug Evaluation and Research. The letters warned companies that the language used to describe the benefits of CBD amounted to adulterated foods and misbranded drugs. Following the November 25, 2019, update, consumers filed several…
The Government Accountability Office (GAO) has released a recommendation that the U.S. Food and Drug Administration (FDA) establish a process that ensures the agency tests at least one shipment of imported seafood before removing it from alert status. GAO reviewed 274 removal decisions between 2011 and 2018 and found that FDA did not conduct audits for 260, or 95%, of the decisions. "FDA officials said they conducted limited sampling because many import alert removal decisions can be supported by documentary evidence provided by firms," GAO announced. "Additionally, for certain violations that indicate a firm failed to meet regulatory or administrative requirements and may pose a public health hazard, an FDA directive establishes a goal for FDA staff to conduct a follow-up inspection within 6 months. However, GAO's review of removal decisions found that for 31 of the 32 firms that received such a finding, FDA did not conduct a follow-up…
A consumer has filed a putative class action alleging Whole Foods Market Group Inc. lists "organic dehydrated cane juice solids" as an ingredient in its 365 Everyday Value instant oatmeal rather than "sugar." Warren v. Whole Foods Mkt. Grp. Inc., No. 19-6448 (E.D.N.Y., filed November 15, 2019). "Consumers expect ingredients on a product to be declared by their common or usual name," the complaint asserts. "Where an ingredient contains the term 'juice,' consumers expect that ingredient to be derived from a consumable fruit or vegetable." The plaintiff seeks class certification, injunctive relief, damages and attorney's fees for alleged negligent misrepresentation, fraud and breach of express warranty.
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…
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 Center for Food Safety (CFS) has submitted a letter to the U.S. Food and Drug Administration's (FDA's) Office of Food Additive Safety arguing that the sale of "uncooked Impossible Burgers to consumers in grocery stores" is unlawful because FDA "received timely objections to the agency's approval of Impossible Foods' color additive petition." CFS argues that its six objections to FDA's ruling should have automatically stayed the effective date of the rule. The letter describes grocery stores' advertising promising the availability of Impossible Burgers, asserting that "such sales are unlawful until there is a valid color additive regulation in place." The advocacy group concludes by urging FDA to "issue a recall notice to these and other retailers that are currently selling uncooked Impossible Burgers in their grocery stores."
Sen. Chuck Schumer (D-N.Y.) has reportedly called for action from the U.S. Food and Drug Administration (FDA) in response to a study purportedly showing that 95% of baby foods contained at least some lead, arsenic, mercury or cadmium content. Schumer reportedly said that consumers "rightfully expect those foods to be undeniably safe, appropriately regulated and nutritiously sustaining" and called for regulators to examine the study and release a public statement on its results.
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…
