House Committee Passes Organic Food Bill Amendment

The AP (5/18, Jalonick) reports that that tension over organic and traditional food-industry groups “boiled over” last week “during a late-night House Agriculture Committee debate on farm legislation” after Rep. Kurt Schrader (D-OR), a “former organic farmer, offered an amendment to make it easier for organic companies to organize industry-wide promotional campaigns,” prompting a “swift backlash from some farm-state Republicans.”

For example, Rep. Mike Conaway (TX) “took issue with part of the amendment that would allow the organic producers to opt out of other commodity campaigns, an option that isn't given to conventional producers.”

In contrast, Rep. Vicky Hartzler (MO), “who owns a farm equipment business and a non-organic corn and soybean farm, said she supported the amendment not only because helping organics is good for agriculture but because many of her constituents eat organic foods.” Still, the committee adopted the amendment, with a 29-17 vote; and eight of the 29 favorable votes came from Republicans.

Regulators Still Reviewing Mercury In Fish Advisory

Reuters (5/16, Clarke) quotes from a letter that about 40 experts and environmental advocacy group representatives sent to Health and Human Services Secretary Kathleen Sebelius in April, in which they emphasized that research “carried out in the past decade has both clarified the beneficial nutritional effects of fish consumption during pregnancy and found adverse effects of prenatal methylmercury exposure at very low doses, at least an order of magnitude below exposures known to be harmful when the current Advisory was written.” 

Reuters says that the Food and Drug Administration and the HHS have indicated that the mercury in fish advisory, which hasn't been updated since 2004, is still under review, but declined to elaborate on what stage of the process the guideline is in or when it could be ready for posting publicly to obtain comment.

Food Safety Modernization Act: Industry Leaders Urge Groups To Submit Produce-Safety Rule Comments

The Packer (5/17, Wilkinson, 13K) reports that after the produce-safety “regulations become final under the Food Safety Modernization Act, the industry will have to live with them for a long time. With that in mind, panelists at the May 15 FSMA workshop at United Fresh 2013” in San Diego, “strongly urged attendees to file comments with the Food and Drug Administration before the Sept. 16 deadline.” 

For example, The Packer quotes Giumarra Cos. Food Safety VP Walter Ram, who served as one of the panelists, as saying, “Don’t think that your input isn’t important,” but after the rule is finalized, it “will take an act of Congress to change,” Ram emphasized. 

Separately, The Packer (5/17, Hornick, 13K) reports Sacramento-based California Leafy Greens Marketing Agreement is preparing to respond to the FSMA on several levels, from “upgrading food safety training to taking a possible role” in compliance verification. The primary issue “for us is how the FDA will verify compliance,” LGMA CEO Scott Horsfall “said on the United Fresh trade show floor.” 

The group is suggesting the FDA use the California and Arizona LGMAs “as the mechanism to verify compliance once the rules are final. We just don’t want to see another layer of audits, inspections and regulations,” Horsfall added, according to The Packer.

Creatine May Alleviate Fibromyalgia Symptoms, Improve Strength

Reuters (5/3, Stokes) reported that creatine supplements may be a good non-drug alternative to fibromyalgia medications, suggests a study published in the April 1 issue of the journal Arthritis Care & Research. In the double-blind, randomized, placebo-controlled trial, the researchers at the University of São Paulo School of Physical Education and Sports in Brazil gave 23 patients with fibromyalgia daily doses of either creatine supplements or placebo tablets for 16 weeks.

They found that the 15 trial participants in the creatine arm had a significant improvement in pain levels, moods, sleep quality and muscle strength compared to the 13-person placebo group, which reported no changes in the aforementioned qualifiers. Reuters noted that although at present, there are a number of FDA-approved treatments on the market — Cymbalta (duloxetine) and Savella (milnacipran), which are antidepressants; Lyrica (pregabalin), which was initially developed for nerve pain; and several anti-seizure therapies and sedatives — they have not been especially effective in alleviating fibromyalgia symptoms and many of them include unpleasant side effects.

FDA’s Taylor Calls Caffeine-Infused Foods “Very Disturbing.”

In continuing coverage, The Hill (5/4, Hattem, 21K) “RegWatch” blog reported Food and Drug Administration Deputy Commissioner for Food and Veterinary Medicine Michael Taylor “called caffeine additives in snacks from jellybeans to waffles to energy drinks ‘very disturbing to us’ in an interview posted by the agency on Friday.”

Although earlier last week, Taylor “announced that the FDA would investigate” the health effects of caffeine-infused foods, in the remarks published Friday on the FDA’s website, “he seemed skeptical about the possibility of imposing age restrictions on caffeine,” according to The Hill. The agency’s safety probe on caffeinated food products was prompted by “Wrigley’s recent launch of Alert Energy Caffeine Gum, a product Taylor called ‘just one more unfortunate example of the trend to add caffeine to food.’”

The Los Angeles Times (5/4, Venteicher, 692K) and the New York Times (5/3, O'Connor, 1.68M) “Well” blog also provided more coverage on the FDA’s decision to investigate caffeine-infused food products.

FDA Responds To EWG “Superbugs” On Meat Report

In Forbes (4/22, 928K), contributor Beth Hoffman published a response from the FDA regarding a recently released report by the Environmental Working Group “on the presence of ‘superbugs’ on meat products in grocery stores” that she covered. 

FDA Spokesperson Jalil Isa wrote that the EWG report “oversimplifies the NARMS data. EWG’s evaluation of the NARMS findings does not take into account important differences between various forms of bacteria and antibiotics. The EWG report cites some pathogens that don’t lead to food-borne illnesses or focuses on resistance to antibiotics that are not commonly used to treat sick people. .... The numbers cited are also misleading. We do not believe that EWG fully considered important factors that put these results in context: whether the bacterium is a foodborne pathogen (Enterococcus is not considered a foodborne pathogen), which drug(s) the bacterium are resistant to (for example, most Enterococcusfaecalis is naturally resistant to the antibiotic class of lincosamides), and whether the main therapies for the pathogen are still effective (NARMS data indicates that first-line treatments are still effective).”

Judge Finds FDA’s Rule Delays Violate Food Safety Law

Bloomberg News (4/23, Gullo) reports that a Federal judge on Monday ruled that the US Food and Drug Administration “is violating food-safety law by delaying regulations intended to help prevent outbreaks of food-borne illnesses.”

US District Judge Phyllis Hamilton “in Oakland, California, said the agency has ‘admittedly failed to comply with the mandatory rule-making schedule’ of the Food Safety and Modernization Act,” which President Obama signed into law by “in January 2011. 

The FDA had 18 months to issue new regulations. The agency said the “aggressive timelines” have “proven to be unachievable,” Hamilton said in a ruling.” She “ordered the FDA to come up with proposed deadlines for regulations by May 20.”

Agra-Net.com (4/23) reports the “final menu labeling rules are in the ‘home stretch’ and will be published this year. New legislation would be needed to charge the food industry additional fees to help pay for the FDA Food Safety Modernization Act. And FDA is doubling its comment period for the preventive controls and produce safety proposals it published in January,” according to testimony FDA Commissioner Dr. Margaret Hamburg gave recently “before the FDA-USDA appropriations subcommittee.”

FDA CVM Director Responds To Bacteria In Meat Report

In a New York Times (4/24, Subscription Publication, 1.68M) letter-to-the editor, the Food and Drug Administration’s Center for Veterinary Medicine Director Dr. Bernadette Dunham responds to an April 17 article “about the Environmental Working Group’s interpretation of government data on antimicrobial resistant bacteria in meat,” noting that the some data in the National Antimicrobial Resistance Monitoring System “may have limited direct medical relevance, and it’s important to consider which drugs are used to treat infections and which bacteria actually cause food-borne illness.”

Moreover, Dr. Dunham calls the EWG’s conclusion “that resistance in any bacterium is problematic for human health” an “oversimplication” because some “bacteria are naturally resistant to certain drugs. Also, describing bacteria that are resistant to one, or even a few, drugs as ‘superbugs’ is inappropriate” because superbugs are “pathogens that can cause severe disease and are very difficult to treat,” she notes.

Industry Groups Oppose Food Safety Tax

Food Safety News (4/22, Bottemiller) reports the President’s “FY 2014 budget released earlier this month seeks a $295 million increase” for the Food and Drug Administration’s “food program, but the vast majority of the boost would come from new fees that Congress has not mandated, including $59 million in registration and inspection fees and $166 million in import fees, to help the agency roll out the Food Safety Modernization Act.”

Prior to a “hearing late last week, a coalition of industry groups sent a letter to Sens. Mark Pryor (D-AR) and Roy Blunt (R-MO), the chair and ranking member of the Senate appropriations subcommittee on agriculture and other agencies, urging the committee to ‘appropriately fund’ food safety at FDA ‘rather than support the imposition of any new food regulatory taxes.’”

At the hearing, when Pryor asked FDA Commissioner Dr. Margaret Hamburg about the issue, she said, “I do think it’s appropriate that our budget reflect that with a combination of budget authority commitment and user fees.”

Ricardo Gomez