FDA Warning Letter - Dry Cereal Facility in GA Cited for Insanitary Conditions

FDA issued a Warning Letter to a Georgia cereal manufacturing facility finding that product  have been "prepared packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health."

The items noted on the inspection:

1. Did not take effective measures to exclude pests from your food plant to protect against contamination of food - lots of bugs.
2. The plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials - many areas with dripping condensate - not a good thing in a dry cereal facility.
3. Equipment and utensils were not adequately maintained to protect against allergen cross-contact and contamination including storing food containers directly on, or close to the ground, and rusted food contact surfaces.
4. Plant floor was in rough shape.

In a dry cereal facility such as this, Salmonella and allergens are two important hazards requiring control.  With the issues cited in this report, the risk of those hazards certainly increases.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-cereal-products-590804-11192019
California Cereal Products
MARCS-CMS 590804 — November 19, 2019

Miss. Establishment Recalls Chicken Friend Rice After Complaints for Plastic Pieces

Ajinomoto Foods North America, Inc., an Oakland, Miss. establishment, is recalling approximately 172,692 pounds of chicken fried rice products that may be contaminated with extraneous materials, specifically pieces of plastic.  The problem was discovered after the firm received consumer complaints. The firm then notified FSIS of the issue.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-117-2019-release
Ajinomoto Foods North America, Inc. Recalls Chicken Fried Rice Products Due To Possible Foreign Matter Contamination
Class II
Recall 117-2019
Health Risk:Low
Nov 22, 2019

FDA Updates E. coli Outbreak Linked to Romaine From Salinas, CA

FDA issued an update on the outbreak investigation on the E. coli O157:H7 outbreak associated with Romaine lettuce from Salinas, CA.  There have been additional cases added since the FDA Warning on Romaine as a source was issued on 11/22/19.  There are now 67 cases with 39 being hospitalized.  The last case reported was November 14th.

FDA is now investigating farms in the Salinas area where the product originated.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-e-coli-o157h7-outbreak-linked-romaine-salinas-california-november-2019
Investigation of E. coli O157:H7 Outbreak Linked to Romaine from Salinas, California, November 2019
FDA investigating farms in Salinas, warns against eating romaine lettuce from that area, CDC reports increasing case count
November 26, 2019

Case Counts
Total Illnesses: 67
Hospitalizations: 39
Deaths: 0
Last illness onset: November 14, 2019
States with Cases: AZ (3), CA (4), CO (1), ID (3), IL (1), MD (4), MI (1), MN (3), MT (1), NE (1), NJ (1), NM (2), OH (12), OR (1), PA (3), TX (2), VA (2), WA (1), WI (21)

FDA Issues Consumer Advisory on Products Containing Cannabis Derived Compounds, Including CBD

FDA issued a consumer advisory on products containing cannabis-based ingredients including CBD.  To this point, CBDs are not permitted to be added to food.  There is limited research that demonstrates the safety of the products and there are some major concerns.

Unfortunately, the horse is out of the barn and it will be difficult to get sales of CBD under control.  A good bet will come down to a major lawsuit or two involving some poor saps who took too much and damaged their liver, become psychotic, or similar.  Nothing like a few major cases of illness to get regulations in place.

https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

FDA Taking Stronger Stance on CBD, Issues Warning Letters to 15 Companies Selling CBD

The US FDA took a stronger stance on CBD from hemp.  The FDA issued "warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act)".   Outside of one product used to treat epilepsy, this compound has not been given GRAS status.  Technically, it is not supposed to be in food, but many companies are adding it.

The reason is that there is still not much research to support the safety of the product.  "Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food."   There are big concerns regarding the use of CBD,  "including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women."

In the FDA statement, FDA "remain[s] concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. 

The Warning Letters, issued to 15 companies are those who are using the web to make claims.
"As outlined in the warning letters issued today, these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods."

FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details
FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods
For Immediate Release:November 25, 2019

Tuna Recall for Histamine Expanded

Northern Fisheries LTD of Little Compton, RI, has expanded their voluntary recall of frozen, wild-caught yellowfin Tuna Medallions (product of Vietnam) to include product sold directly to consumers. This recall is due to potentially elevated levels of histamine. 

The tuna product is imported from Vietnam.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/northern-fisheries-ltd-voluntary-expanded-tuna-recall-press-release
Northern Fisheries LTD. Voluntary Expanded Tuna Recall Press Release
Summary
Company Announcement Date: November 22, 2019
FDA Publish Date:November 25, 2019
Product Type:Food & Beverages Fish
Reason for Announcement: Elevated Histamine Levels
Company Name: Northern Fisheries LTD
Brand Name: Tuna King
Product Description: Yellowfin Tuna Medallions

FDA Issues Warning About Eating Romaine Lettuce from Salinas, CA Due to E. coli O157:H7

FDA issued a warning about eating Romaine lettuce from Salinas, CA after that produce was linked to 40 cases of E.coli O157:H7.  

Salad product from Missa Bay LLC in NJ had already been recalled and this comes after MD Dept of Health had isolated the pathogen from a salad kit.

Retailers and foodservice operations will need to verify the source of lettuce they have and provide that information to consumers.  Product from Salinas will not be sold.   If they can't identify the source, they will not be able to sell it either.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-e-coli-o157h7-outbreak-linked-romaine-salinas-california-november-2019
Investigation of E. coli O157:H7 Outbreak Linked to Romaine from Salinas, California November 2019
FDA warns against eating romaine lettuce from Salinas, California
November 22, 2019

Case Counts

Total Illnesses: 40
Hospitalizations: 28
Deaths: 0
Last illness onset: November 10, 2019
States with Cases: AZ (2), CA (4), CO (1), ID (3), IL (1), MD (3), MI (1), MN (1), MT (1), NJ (1), NM (2), OH (5), PA (3), VA (1), WA (1), WI (10)

CDC Final Report on Cyclospora Cases in 2019

CDC issued the final report on Cyclospora infections in 2019.  There were 2048 cases of infection from this parasite.  Of these cases, 10% were linked to fresh basil, while others were linked to a few different fresh produce items distributed often in commercially sold salads.

Cyclospora is a human parasite (humans are the definitive host).  In humans, "Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, with frequent, sometimes explosive, bowel movements. Other common symptoms include loss of appetite, weight loss, stomach cramps/pain, bloating, increased gas, nausea, and fatigue. Vomiting, body aches, headache, fever, and other flu-like symptoms may be noted. Some people who are infected with Cyclospora do not have any symptoms."

"The time between becoming infected and becoming sick is usually about 1 week. If not treated, the illness may last from a few days to a month or longer. Symptoms may seem to go away and then return one or more times (relapse). It’s common to feel very tired."

https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2019/a-050119/index.html
Domestically Acquired Cases of Cyclosporiasis — United States, May–August 2019
Last Updated NOVEMBER 19, 2019 4:00 PM EDT

CDC Report - 2017-2019 Salmonella Infections Linked to Raw Turkey Products

Just in time for Thanksgiving, a reminder of why we need to cook our turkey to the correct temperature and prevent against cross contamination through proper cleaning of surfaces and utensils that came in contact with raw turkey or juices as well as proper handwashing after handling raw turkey and surfaces that can in contact with raw turkey (turkey bag, utensils, etc)

"During 2018–2019, CDC, local and state public health partners, the U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA) investigated a multistate outbreak of 356 Salmonella Reading infections from 42 states and the District of Columbia (DC) linked to turkey. The outbreak strain was isolated from raw turkey products, raw turkey pet food, and live turkeys."

"The two illness subclusters in this outbreak indicate improper handling and cooking of raw turkey products and highlight the need to reinforce consumer education." 

As pointed out by USDA, many factors can affect roasting time, so take them into account.

• A partially frozen turkey requires longer cooking.
• A stuffed turkey takes longer to cook.
• The oven may heat food unevenly.
• Temperature of the oven may be inaccurate.
• Dark roasting pans cook faster than shiny metals.
• The depth and size of the pan can reduce heat circulation to all areas of the turkey.
• The use of a foil tent for the entire time can slow cooking.
• Use of the roasting pan's lid speeds cooking.
• An oven cooking bag can accelerate cooking time.
• The rack position can have an effect on even cooking and heat circulation.
• A turkey or its pan may be too large for the oven, thus blocking heat circulation.

Goal - End point temperature of 165F or higher (use thermometer, check in multiple locations) - the higher the drier, but that is okay.

APPROXIMATE COOKING TIMES
(325 °F oven temperature)
UNSTUFFED (time in hours)

• 4 to 6 lb. breast — 1 1/2 to 2 1/4
• 6 to 8 lb. breast — 2 1/4 to 3 1/4
• 8 to 12 lbs. — 2 3/4 to 3
• 12 to 14 lbs. — 3 to 3 3/4
• 14 to 18 lbs. — 3 3/4 to 4 1/4
• 18 to 20 lbs. — 4 1/4 to 4 1/2
• 20 to 24 lbs. — 4 1/2 to 5

STUFFED (time in hours)

•  Up to 12 lbs. — 3 to 3 1/2
• 12 to 14 lbs. — 3 1/2 to 4
• 14 to 18 lbs. — 4 to 4 1/4
• 18 to 20 lbs. — 4 1/4 to 4 3/4
• 20 to 24 lbs. — 4 3/4 to 5 1/4

CDC MMWR
https://www.cdc.gov/mmwr/volumes/68/wr/mm6846a1.htm
Multistate Outbreak of Salmonella Infections Linked to Raw Turkey Products — United States, 2017–2019