Friday, December 18, 2020

FDA Proposes Removing Standard of Identity for French Dressing

The US FDA announced that it was proposing to remove the Standard of Identity for French Dressing. The Standard of Identity, as we know, provides a standardized definition for a food item, in this case, French Dressing, so that when a consumer buys it from the store, they sort of know what they are buying.
"This proposed rule, if finalized, would revoke the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS) (petition). We tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers and revoking the standard could provide greater flexibility in the product’s manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
"So what is French Dressing?
According to the online dictionary, French Dressing is:

n.
1. A salad dressing of oil, vinegar, and seasonings.
2. A commercially prepared creamy salad dressing that is usually pale orange to reddish-orange in color and often sweet.
From the US  Code of Federal Regulations, the Standard of Identity for French Dressing (entire listing below) states that it contains acidifying agents, vinegar and/or lemon juice, and has not less than 35 percent by weight of vegetable oil. Optional ingredients include egg and tomato juice.

The FDA proposal to remove this standard reasons:
"The petition states that there has been a proliferation of nonstandardized pourable dressings for salads with respect to flavors (Italian, Ranch, cheese, fruit, peppercorn, varied vinegars, and other flavoring concepts) and composition (including a wide range of reduced fat, “light,” and fat-free dressings) (petition at page 3). The French dressing standard of identity, according to the petition, no longer serves as a benchmark for other dressings because of the wide variation in composition to meet consumer interests (id.). Instead, the petition claims that the standard of identity has become marginalized and restricts innovation (id.). Therefore, the petition states that the French dressing standard of identity no longer promotes honesty and fair dealing in the interest of consumers (id.).

One key factor in the standard is the required level of oil.  With the demand for lower fat varieties, this standard limits that.  

When the standard of identity was established in 1950, French dressing was one of three types of dressings we identified (15 FR 5227). We generally characterized the dressings as containing a fat ingredient, an acidifying ingredient, and seasoning ingredients. The French dressing standard allowed for certain flexibility in manufacturers’ choice of oil, acidifying ingredients, and seasoning ingredients. Tomatoes or tomato-derived ingredients were among the seasoning ingredients permitted, but not required. Amendments to the standard since 1950 have permitted the use of additional ingredients, such as any safe and suitable color additives that impart the color traditionally expected (39 FR 39543 at 39554-39555).
Most, if not all, products currently sold under the name “French dressing” contain tomatoes or tomato-derived ingredients and have a characteristic red or reddish-orange color. They also tend to have a sweet taste. Consumers appear to expect these characteristics when purchasing products represented as French dressing. Thus, it appears that, since the establishment of the standard of identity, French dressing has become a narrower category of products than prescribed by the standard. These products maintain the above characteristics without a standard of identity specifically requiring them.
Additionally, French dressing products are manufactured and sold in lower-fat varieties that contain less than the minimum amount of vegetable oil (35% by weight) required by 21 CFR 169.115(a). We are unaware of any evidence that consumers are deceived or misled by the reduction in vegetable oil when these varieties are sold under names including terms such as “fat free” or “low-fat.” By contrast, these varieties appear to accommodate consumer preferences and dietary restrictions. Therefore, after considering the petition and related information, we tentatively conclude that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act. "

Should we care?  This is such a non-specific standard to begin with, brand specific variations may not make much difference to the consumer.  But FDA is "interested in any information, including data and studies, on consumer expectations regarding French dressing and whether the specifications in § 169.115 are necessary to ensure that French dressing meets these expectations."
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 169
[Docket No. FDA-2020-N-1807]

RIN 0910-AI16
French Dressing; Proposed Revocation of a Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

Monday, December 7, 2020

Lawsuit Filed Against Washington State Juice Processor for Mold Toxins and High Arsenic Levels

A lawsuit was filed against a now-defunct company for selling substandard juice made from rotting fruit.  The company processed juice that made its way into the school lunch program.

(perhaps they should have called it kombucha.....) 

City Herald 
https://www.tri-cityherald.com/news/state/washington/article247154559.html
‘Putrid and decomposed’ fruit used in juice for students, Washington lawsuit says
By Brooke Wolford
November 13, 2020 02:04 PM

A Washington company that is no longer in business used rotting fruit to make juice for school children, the Food and Drug Administration said in a lawsuit filed in federal court in Washington.
The Valley Processing plant in Sunnyside, Washington supplied nearly 3 million servings of apple juice a year to the federal school lunch program, the lawsuit said. 

Colorado Issues Health Alert After Uptick in Botulism Cases

Reports of botulism poisoning are very rare, much due to food safety practices that focus on preventing this deadly foodborne disease. So Colorado health officials became concerned when there was five cases of botulism poisoning since September. While there is no source for three of the cases in the report, two of the cases were related to improperly processed home-canned foods.


https://cdphe.colorado.gov/press-release/increase-in-foodborne-botulism-cases-prompts-warning-from-health-officials-about-home
Increase in foodborne botulism cases prompts warning from health officials about home food safety 

This Week in Mislabeled Products for December 7, 2020

Print and Apply Label Missing Almonds - Market of Choice of Eugene, Oregon, is recalling its in-house Sour Cherry Baked Brie because of undeclared almonds.  The recall was initiated after it was discovered that almonds were present but were not declared on the ingredients list.

Testing Finds Gluten in Gluten-Free Product - Flowers Foods, Inc. (NYSE: FLO) is recalling certain Canyon Bakehouse Mountain White Bread and Canyon Bakehouse Everything Bagels due to the potential presence of gluten .  The recall was initiated after finished product testing revealed the possible presence of gluten.

Mislabeled Chocolate Misses Dairy - Maribel’s Sweets of Brooklyn New York is recalling its 5oz Cacao Market Cylinder Dark Chocolate Pearls, because they contain undeclared milk.  The recall was initiated after it was discovered that product containing milk was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

Testing Finds Presence of Dairy - Hong Thai Foods Corp. of Brooklyn, NY issued 2 recalls, recalling its 7.76 ounce packages of Golden Boy Custard Muffin Original because they may contain undeclared milk allergens and are adulterated with Uranine- Acid Yellow 7 and 7.76 ounce packages of Golden Boy Custard Muffin Pandan because they may contain undeclared milk allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens

Leaky Valve Bleeds In Egg Nog - Prairie Farms has issued a limited voluntary recall of its Prairie Farms Premium Flavored Chocolate Milk gallons and Prairie Farms 1% Lowfat Chocolate Milk gallons (Best by Date: Dec. 4, 2020) that were not labeled for an egg allergen that may be present.  The recall was initiated after cross-contamination with egg nog was discovered following a valve malfunction at the Rockford, Illinois plant.

Mislabeling of Banana Chocolate Chip Muffins - Riverside Natural Foods, of Vaughan, ON is voluntarily recalling its 8 ounce packages of " Good & Gather Banana Chocolate Chip Date & Nut Bar " because they were improperly labelled and may contain undeclared almonds. The product is labelled to may contain tree nuts; however, people who have allergies to almonds may experience a serious or life-threatening allergic reaction   The recall was initiated after it was discovered that the almond-containing product was distributed in packaging that did not reveal the presence of almonds. Subsequent investigation indicates the issue was caused by an error in the company's packaging processes.

Baby Spinach from Canada Recalled for Potential Salmonella Contamination

A Canadian company has recalled is recalling Fresh Attitude baby spinach (5oz and 11oz)  because it has the potential to be contaminated with Salmonella.  "The recall was initiated after it was discovered that the product was possibly contaminated with Salmonella subsequent investigation indicates that the problem may have been caused by contamination of a part of a lot of Baby Spinach." [not really sure what that means...perhaps testing of a specific lot of baby spinach was positive for Salmonella?]  There have been no reported illnesses, indicating it was not an investigation but rather routine testing?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vegpro-international-issues-recall-fresh-attitude-baby-spinach-because-potential-salmonella-health
Vegpro International Issues a Recall of Fresh Attitude Baby Spinach Because of Potential Salmonella Health Risk
Summary
Company Announcement Date:  November 27, 2020
FDA Publish Date:  November 28, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Vegpro International
Brand Name:  Fresh Attitude
Product Description:  Baby spinach

FDA Issues Warning Letter to Potato Chip Manufacturer for Allergen Mislabeling

FDA issued a Warning Letter to Frito Lay for two allergen related issues that resulted in recalls.    One occurred when at the Bakersfield, CA facility when  incorrect seasoning containing undeclared milk was applied to Lay’s Barbecue Flavored Potato Chips  and the other was a mislabeling issue at the Vancouver, WA facility when  bags of Ruffles Cheddar & Sour Cream Potato Chip potato chips were labeled “Ruffles Original Potato Chips”.  Basically, the two facilities had procedures but did not follow them.

Mislabeling at WA facility

According tot the report , the facility did not adequately implement food allergen controls at the packaging step allowing incorrect labeling where Ruffles Cheddar & Sour Cream Potato Chips were bagged as Ruffles Original bags, thus an undeclared major food allergen, milk. 

In this case, the facility did not implement their roll change procedure - they were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, the bagmaker operator incorrectly used the Ruffles Original film. 

The allergen control procedure, “Film Splice Tracking,” is in place to indicate that at roll change the person will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and then a second person will verify the labeling film code. 
  • These splice operations were not documented on the form. 
  • Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. 
  • Further, the firm discontinued attaching the labeling film splice to the form in June of 2020.
Additionally, there was a procedure to verify the correct product is in the correct package and bag coding/case coding information is accurate. "The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.”   Further wo employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted."

Allergen Cross Contact at the Bakersfield CA facility

The firm did not adequately implement the "Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. "These procedures indicate that [the firm] will verify that all visible evidence of prior seasoning is removed [after] cleaning. On September 23, 2020, (b)(4) cleaning of packaging line (b)(4) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (b)(4) cleaning, was observed by our investigator. In particular, three orange residues approximately one millimeter in size were observed on the (b)(4) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (b)(4). These residues were observed after you conducted a (b)(4) clean-out and documented on your “(b)(4)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by your PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk."

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frito-lay-inc-611243-11242020
WARNING LETTER
Frito-Lay, Inc.
MARCS-CMS 611243 — November 24, 2020 

Sunday, December 6, 2020

Research - Those Darn Wooden Pallets Can Lead to Injuries

A research study out of Penn State brings to light what we have known all along - those darn wooden pallets can be an injury hazard in non-occupational settings.  "The first-ever investigation of non-occupational injuries that occur due to unintentional contact with pallets yielded startling statistics, Michael noted. From Jan. 1, 2014, to Dec. 31, 2018, there were an estimated 30,493 people who visited hospital emergency rooms for pallet-related injuries."

Certainly those professionals who work in warehouse settings know the issues, but there is an increase use of pallets in retail settings, such as in warehouse stores and retail settings where product is displayed on pallets.  Often times, these pallets are not new pallets, or grade A pallets, but those overly used pallets that are one nail from falling apart.  Then there is the consumer use of those worn-out pallets.  According to the authors...."The immense number of pallets allows for broken or beaten-up pallets to be lost from the system and grabbed by homeowners for DIY projects.....Or they break up pallets for firewood or stack firewood on them. They’re not careful and they get hurt.”

Penn State News
https://news.psu.edu/story/640525/2020/12/02/research/after-shipping-pallets-pose-big-risk-public-cause-many-accidents
After shipping, pallets pose big risk to public, cause many accidents, injuries
Pallets were responsible for sending more than 30,000 people to ER in five-year span
PUBLISHED ON December 3, 2020

Research - Desensitizing Children with Peanut Allergies Through Oral Immunotherapy

Research out of the University of British Columbia found that children with peanut allergies can be desensitized through "exposing children to a small, regular dose of an allergen (in this case, peanuts) in a real-world setting (outside of a clinical trial)" and this is "effective in reducing the risk of allergic reactions."  We are familiar with the process of preventing peanut allergies through the process of feeding infants doses of peanut allergen, but this is for those children who have developed peanut allergies.

"The treatment method, known as oral immunotherapy, involves gradually increasing the amount peanuts (or peanut products) given to the child. One treatment aim is to reach desensitization, whereby the child can ingest a full serving of peanuts without triggering a dangerous reaction. Another goal is protection in the event of an accidental exposure, and lessening or eliminating the need for epinephrine injections in response to reactions. To sustain their level of immunity, the child must continue to eat peanut products on a regular basis."

University of British Columbia
https://news.ubc.ca/2020/12/03/peanut-allergy-treatment-significantly-lowers-risk-of-life-threatening-reactions-in-preschoolers/
Peanut allergy treatment significantly lowers risk of life-threatening reactions in preschoolers
Science, Health & Technology
Dec 3, 2020 | For more information, contact Kerry Blackadar

Thursday, December 3, 2020

FDA Issues Reminder to Facilities for Biennial Registration

FDA issued a reminder that U.S. and foreign human and animal food facilities under FDA jurisdiction must renew their registration this year before December 31.

"The FDA will consider the registration of a food facility to be expired if the facility does not renew its registration by December 31, 2020. There is no fee associated with registration or renewal. Owners and operators of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission."

https://www.fda.gov/food/cfsan-constituent-updates/fda-reminds-human-and-animal-food-facilities-about-years-biennial-registration-renewal-period-and
FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number

Constituent Update
December 1, 2020

U.S. and foreign human and animal food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year before December 31.