The Food and Drug Administration (FDA) has issued draft guidance that, in part, addresses the use of nanotechnology in food processing. Among other matters, “FDA considers food manufacturing processes that involve nanotechnology in the same manner as any other food manufacturing technology,” although the agency also apparently recognizes that “nanotechnology and other emerging technologies may introduce issues that warrant additional or different evaluation during a safety assessment of a food substance. For example, so-called nano engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.” Accordingly, FDA states, “When a food substance is manufactured to include a particle size distribution shifted more fully into the nanometer range, safety assessments should be based on data relevant to the nanometer version of the food substance. Where nano engineered food substances have new properties, additional or different testing…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has released industry guidance and a draft regulation about a new voluntary initiative intended to decrease the use of antimicrobials in agricultural animals. According to an April 11, 2012, press release, FDA has issued final guidance for industry titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which “recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.” The agency has also published draft guidance that urges animal pharmaceutical companies to voluntarily remove “production uses of antibiotics from their FDA-approved product labels” and “add, where appropriate, scientifically-supported disease prevention, control, and treatment uses.” These two sets of guidance are supplemented with a proposed veterinary feed directive outlining “ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible…
A federal court in Iowa has dismissed claims filed by a legal defense fund and a number of raw-milk producers challenging Food and Drug Administration (FDA) regulations prohibiting the shipment of raw milk for human consumption across state lines. Farm-to-Consumer Legal Defense Fund v. Sebelius, No. 10-4018 (N.D. Iowa, decided March 30, 2012). According to the court, none of the plaintiffs alleged that “the FDA has applied or sought to apply the challenged regulations to them, and Wagoner’s contentions are merely conclusory and based on speculation.” Raw milk producer Eric Wagoner had apparently alleged that a Georgia Department of Agriculture official “ordered an embargo of raw milk that he had transported from South Carolina, where it is legal to buy raw milk, to Georgia, where it is not” and claimed that “the embargo was ordered at the direction of the FDA.” There was no evidence of FDA involvement, and because…
First synthesized by a Russian chemist in 1891 and deemed safe by the Environmental Protection Agency in 1976 when grandfathered in along with 62,000 other chemicals under the Toxic Substances Control Act, bisphenol A (BPA) was today confirmed for continued use in food packaging materials by the Food and Drug Administration (FDA). According to news sources, the agency rejected the Natural Resources Defense Council (NRDC) petition to ban the chemical, finding that the scientific evidence cited in the petition cannot be applied to humans, and the studies were too small or involved injecting BPA into animals rather than ingested over time, which is how human exposure occurs. See The New York Times, March 30, 2012. Produced at an annual rate of more than 8 billion pounds worldwide, BPA has been detected in the urine of nearly every adult and child tested in the United States, and, while it is quickly…
Del Monte Fresh Produce has reportedly informed Oregon Public Health and state Senior Epidemiologist William Keene that it will not act on its notice to sue over their identification of the company’s imported cantaloupes as the source of a 2011 Salmonella outbreak. Additional details about the litigation threat appear in Issue 408 of this Update. While a spokesperson refused to comment on the company’s action, its letter apparently indicated that the withdrawal was “a show of good faith” in its food safety discussions with the state; it is seeking a meeting with state food safety scientists. Del Monte Fresh Produce also sued the Food and Drug Administration (FDA), claiming that the agency lacked an adequate factual basis to conclude that the company’s Guatemalan cantaloupe supplier was the source of the contamination. The company sought to lift FDA’s import alert which prohibited it from importing from its Guatemalan source without proving the…
A federal magistrate judge in New York has ordered the Food and Drug Administration (FDA) to begin proceedings to withdraw approval for the subtherapeutic use of certain antibiotics in animal feed, agreeing with the Natural Resources Defense Council (NRDC) and a coalition of advocacy organizations that the agency had a statutory duty to hold withdrawal proceedings after issuing notices in 1977 of its intent to withdraw approval because the use of such drugs had not been shown to be safe. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided March 22, 2012). According to the court, “if the Secretary finds that an animal drug has not been shown to be safe, he is statutorily required to withdraw approval of that drug, provided that the drug sponsor has notice and an opportunity for a hearing.” Further details about the lawsuit appear in Issue 396 of this Update. Questions about whether the agency has…
The National Consumers League has written to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, asking the agency to take enforcement action against several companies that label their products as “100%” lemon juice, while they actually contain 35 percent or less lemon juice. According to the March 21, 2012, letter, “The products tested omit requisite amounts of real lemon juice and substitute water, citric acid, and in some cases sugar. The cheating is concealed by labeling the products as ‘100%’ lemon juice or simply ‘Lemon Juice from concentrate,’ and the producers make it appear that the products are of greater value than they really are.” Included with the letter are labels from four different products and lab reports from the company that apparently tested them. The National Consumers League characterizes the juice as “heavily diluted with water beyond what is necessary and appropriate to reconstitute the product.” Its letter also…
The Food and Drug Administration (FDA) has issued a warning letter to Staples, Inc. concerning inspections conducted at its California facility where food products are stored. FDA apparently discovered “serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.” Among other matters, rodent excreta pellets were found on or near “at least 11 different food products, including various brands of candies, crackers, creamers, pistachios, ramen noodles, and bottled water.” The inspectors also apparently found dead rodents in traps throughout the facility and rodent gnawed holes on individual food packages. FDA acknowledged that the company voluntarily destroyed food products under the agency’s supervision in October 2011 and that the company repaired six roll-up doors at the facility. Still, because the company did not document its corrections with photographs or include a site map indicating the placement of rodent traps or pest control records with its response, it had not…
Fifty-five members of Congress have sent a letter to the Food and Drug Administration (FDA) in support of a legal petition demanding the labeling of genetically engineered (GE) foods. Signed by 10 senators and 45 representatives, the March 12, 2012, letter urges FDA “to protect a consumer’s right to know, the freedom to choose what we feed our families, and the integrity of our free and open markets.” Filed in October 2011 by the nonprofit Center for Food Safety, the petition reportedly has the support of more than 400 health and consumer agencies and has received nearly a million comments in favor of GE labeling, the lawmakers said. They assert that FDA’s 1992 policy statement allowing GE foods to be marketed without labeling is inadequate and outdated because it merely covers foods changed “materially” by taste, smell or other senses. “The use of novel food technologies like genetic engineering on…
Part II of the American Bar Association’s (ABA’s) Nanotechnology Project, this recently released book comprehensively considers, by product category, how the Food and Drug Administration (FDA) reviews nanotechnology-based products. Shook, Hardy & Bacon Agribusiness & Food Safety Attorney James Andreasen was among those practitioners contributing to the work. Among the chapters are “Color Additives,” “Food Additives and Related Substances,” “Dietary Supplements,” “Food and Animal Feed Products,” and “Biological Products.” They address “how FDA can, and to some extent, has, regulated nanomaterials in products falling under its multiple areas of responsibility,” and (i) identify “products that already feature nanomaterials”; (ii) review “FDA’s regulatory program for the specific product category (such as particular pre-market and post-market controls)”; and (iii) discuss “how that program might apply to nanomaterials.”
