The U.S. Food and Drug Administration (FDA) has released a strategic policy roadmap for 2018 identifying four primary areas on which the agency will focus this year: (i) combating addiction; (ii) improving public health; (iii) ensuring consumers are better-informed about diet, health and nutrition; and (iv) strengthening the agency’s workforce and upgrading its technological resources. In an effort to "use nutrition to reduce morbidity and mortality from disease," FDA has indicated that it will "take new steps in 2018 to implement a comprehensive plan, incorporating a range of new efforts, to leverage dietary information to reduce the burden of disease through nutrition and encourage the development of more healthful food options."
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has extended the comment period for its proposed rule revoking authorization for a health claim that the consumption of soy can reduce the risk of heart disease. The agency proposed the rule in October 2017 and opened a 75-day comment period, but it has extended the deadline until March 19, 2018.
The U.S. Food and Drug Administration (FDA) has issued draft guidance aiming to increase and expedite product warnings and recalls. According to FDA Voice, recall information has historically not been released to the public until after a weeks- or months-long evaluation and classification process. The agency plans to add “not-yet-classified” recalls of drugs, food and veterinary products to its weekly Enforcement Report, but the addition will not affect existing protocols for working with companies. The deadline for submitting public comment is March 20, 2018.
The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs more time to consider "the complex supply chain relationships and resource requirements” related to definitions and required disclosures. Among other issues, FDA stated, are questions about factors such as farm ownership and farm-related activities that affect the determination of what business entities are “farms.” In addition, FDA will delay enforcement of some provisions related to (i) produce safety; (ii) disclosures regarding hazard analyses; (iii) importation of food contact substances under the Foreign Supplier Verification Program; and (iv) human food byproducts used in animal food.
The U.S. Food and Drug Administration (FDA) has announced an amendment to food additive regulations to provide for the use of formic acid and ammonium formate in animal feed and drinking water. Taking effect November 13, 2017, the amendment limits formic acid and salts to 1.2 percent in complete feeds. FDA will accept comments or requests for a hearing until December 13, 2017.
In accordance with an August 2017 announcement, the U.S. Food and Drug Administration (FDA) has released supplemental draft guidance on menu-labeling requirements to address concerns raised by restaurant franchisees, grocery and convenience stores that sell “grab-and-go” food, and others affected by the rule, which is scheduled to take effect in 2018. The guidance provides details on: (i) criteria for covered establishments; (ii) distinctions between menus and marketing materials; (iii) various methods for calculating and disclosing calorie information; (iv) seasonal or special menu items; (v) compliance; and (vi) enforcement. The labeling requirements apply to restaurants or food retailers that are part of a chain of 20 or more locations doing business under the same name and offering substantially similar menu items. Among the non-binding recommendations for labeling include placement of signs “adjacent to, and clearly associated with” the food for sale or on signs attached to sneeze guards; establishments can also…
The U.S. Food and Drug Administration (FDA) is proposing to revoke an authorized health claim linking consumption of soy protein to reduction of the risk of heart disease. FDA first authorized the claim in 1999 after concluding that evidence supported the proposition that soy protein lowered low-density lipoprotein (LDL) cholesterol. The agency states that although “some evidence continues to suggest a relationship,” studies published since 1999 have presented findings inconsistent with the health claim and that the “totality of currently available scientific evidence calls into question the certainty of this relationship.” Other possible benefits of soy consumption will not be affected by the proposed rule. If the claim is revoked, FDA says it will allow the use of a qualified health claim, which requires a lower standard of scientific evidence and would allow the industry to use qualifying language explaining the limited evidence of the link between soy and heart…
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Snyder’s-Lance, Inc. about the iron content of its Lance Toast Chee Crackers. The letter indicates that FDA conducted surveillance sampling purportedly showing that the company’s single-serve cracker packages contained about half of the “10% Daily Value for iron” listed on the product label. The original sample showed 51.7 percent of the amount claimed and the “check” sample showed 57.2 percent, according to the letter. Levels below 80 percent of the amount declared on the label violate federal law, FDA stated. In addition, the bar code “was intervening with” the nutrition label, and the label did not declare the street address of the firm as required unless it appears in a city or telephone directory.
The U.S. Food and Drug Administration (FDA) has proposed an additional extension for compliance with the menu labeling rules required by the Affordable Care Act. Under the proposed rule, the current compliance deadline of July 26, 2018, would be extended to January 1, 2020, for manufacturers with $10 million or more in annual food sales; for manufacturers with less than that amount, the date would be extended to January 1, 2021.
The U.S. Food and Drug Administration (FDA) has warned Nashoba Brook Bakery that it has misbranded its granola by listing “Love” as one of its ingredients. The warning letter informed the company that “'love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.” “Intervening material” refers to information that is not required in FDA labeling and can distract from required content. The letter also cited the bakery for health and sanitary violations as well as misbranding violations for whole-wheat products that contain corn meal.
