INSIGHTS AND ACTIONS

CHILTON CONSULTING GROUP LAUNCHES NEW WEBSITE

Chilton Consulting Group is pleased to announce the launch of its new website this January 2012. The new site sports a fresh look and features streaming news directly from USDA and FDA. The site will also have a “members only” section where clients participating in the CCG-Enhanced Retainer Program can have access to exclusive CCG training materials, scientific validation data, reference articles and other vital manufacturing information. Please plan to visit www.chiltonconsulting.com and see all the new features.

JUICE PRODUCT SAFETY

 Recent media reports have brought into question the safety of juice products, particularly apple juice, manufactured in the United States.  Clients producing juice products and clients using juice products as ingredients may need to respond to customer concerns.  Having the facts at hand may help address potential customer safety questions.

The FDA states that arsenic is a naturally occurring substance ubiquitously present in the environment. It source may be from naturally occurring substance or as a result of contamination from human activity. It is found in water, air, food, and soil. There are two types of arsenic: organic and inorganic. The inorganic forms of arsenic are the harmful forms, while the organic forms of arsenic are essentially harmless. Because both forms of arsenic have been found in soil and ground water, small amounts may be found in certain food and beverage products, including fruit juices and juice concentrates.

 The arsenic testing methods prescribed by the FDA for fruit juices are very specific and differ significantly for those used for testing water. Juice contains higher levels of organic and inorganic materials, requiring more refined arsenic testing methodology. Consequently, the test results reported by the Dr. Oz Show were erroneous as they were based upon a method intended for testing water.  

 The FDA tests juice samples for total (organic and inorganic) arsenic. If arsenic levels are high, the agency then re-tests samples for its inorganic arsenic content, the type of arsenic considered harmful to humans.

 To date, FDA has been tracking total arsenic contamination in apple and other juices through its Toxic Elements program since 2005 and as part of the FDA Total Diet Study program for the presence of arsenic since 1991. FDA monitoring has found that total arsenic levels in apple juice are typically low. FDA considers the general consumption of fruit juices, including apple juice, to be safe. For additional information on juice safety responses visit http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm271595.htm.

FDA CRACKS DOWN ON DIETARY SUPPLEMENT PRODUCERS

In two separate incidences, the FDA has taken enforcement action against U.S. dietary supplement manufactures affecting production and halting manufacturing.  In one instance, the agency took legal action in the form of a permanent injunction against one dietary supplement maker, claiming the substitution of ingredients and products without noting the changes on the final product labels. This injunction stopped the production of more than 400 products.

In a second incident, U.S. marshals seized all dietary supplements produced by the maker for alleged false claims made about product safety and effectiveness in treating a number of diseases. In an FDA press release the agency stated that, “products are unapproved new drugs that may not be introduced into interstate commerce and are misbranded in violation of the Federal Food, Drug, and Cosmetic Act.”

Chilton Consulting Group has developed an extensive regulatory gap analysis spreadsheet for tracking 21 CFR 111 and 21 CFR 110  compliance and coupled that with policy manuals with customized procedures for each regulatory requirement. Contact CCG today should you need assistance with dietary supplement manufacturing compliance assistance.

FSIS RECALLS

FDA RECALLS

AMSA RELEASES SODIUM NITRITE IN PROCESSED MEATS REPORT

A new study entitled, “Sodium Nitrite in Processed Meat and Poultry Meats: A Review of Curing and Examining the Risk or Benefit of its Use,” released by the American Meat Science Association (AMSA) Scientific Information Committee on November 9, 2011 provides a comprehensive benefit analysis for the use of sodium nitrites in processed meats and poultry products. 

Writers Jeffery Sindelar and Andrew Milkowski stated in the paper that the curing practices in the meat and poultry industries have been adjusted as information regarding the potential risks of nitrosamines were reported. The study further reaffirms the safety of products containing sodium nitrite and its metabolites nitric oxide, nitrite, and nitrate particularly  in today’s  modern meat and poultry plants. More information regarding this white paper can be viewed at http://www.meatscience.org/SodiumNitriteReview.aspx.

FSIS DELAYS EFFECTIVE DATE FOR NEW RAW PRODUCT LABELING RULE

FSIS announced on December 9, 2011 in the Federal Register the delay of the effective date of the final regulations requiring nutrition labeling  of the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry products. The original effective date of January 1, 2011, as published in the Federal Register on December 29, 2010, is postponed in response to requests from eight trade associations. The trade associations requested that FSIS exercise enforcement discretion for a  six month period following the January 1, 2012, effective date of the final rule. FSIS has concluded that a two month delay in the effective date will allow industry sufficient time to comply with the requirements of the final rule. The new effective date of the final  rule is March 1, 2012. A full copy of  Docket No. FSIS–2005–0018 can be viewed at http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2005-0018D.pdf

FSIS PROPOSED RULE ON GENERIC LABELING APPROVAL

FSIS announced a proposed rule that would affect generic label approval for meat and poultry products. In a press released dated, December 5, 201, the agency stated that the new rule if finalized  “will allow establishments to label a broader range of products without first submitting the label to FSIS for approval.”  FSIS would continue to verify the accuracy of labels and ensure that they are in compliance with all labeling features. This proposed rule can be viewed at

http://www.gpo.gov/fdsys/pkg/FR-2011-12-05/html/2011-30992.htm