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

Hepatitis A Cases Linked to Fresh Blackberries

A hepatitis A outbreak has been "potentially linked" to blackberries sold by the Fresh Thyme grocery store chain.  To date, there have been 11 cases with 6 hospitalizations in 3 states - Indiana, Nebraska, and Wisconsin.    However, the distributor to Fresh Thyme distributes product in 11 states - Iowa, Illinois, Indiana, Kentucky, Michigan, Missouri, Minnesota, Nebraska, Ohio, Pennsylvania and Wisconsin.  While this product was purchased in the month of September (between September 9 and 30), there is concern that the product may have been frozen by some customers.

One would guess that someone involved in harvesting and/or initial distribution would have had the illness.

https://www.cnn.com/2019/11/21/health/blackberries-hepatitis-a-outbreak-trnd/index.html
Hepatitis A outbreak 'potentially linked' to blackberries from Fresh Thyme stores, officials say
By Harmeet Kaur, CNN
Updated 4:41 PM ET, Thu November 21, 2019

This Week in Mislabeled Product for Week Ending November 23, 2019

Chicken Product in Port Casing - BrucePac, a Silverton, Ore. establishment, is recalling approximately 55,550 pounds of ready-to-eat (RTE) chicken sausage products due to misbranding, the products contain a pork casing, which is not declared on the label.  The problem was discovered when the firm notified FSIS that a third-party consultant identified the mislabeling.

Undeclared Sulfites in Dried Fruit - “Euroline Foods LLC” of Staten Island, NY is recalling its 17.65oz (500 gram) packages of “DRY FRUIT MIX “QUINCE COMPOTE” ” because they contain undeclared sulfites.  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 sulfites in the 17.65oz (500 gram) packages of “DRY FRUIT MIX “QUINCE COMPOTE”“ which were not declared on the label. Analysis of the “DRY FRUIT MIX “QUINCE COMPOTE” ” revealed they contained 31.7 mg per serving.  (The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. )

Salad Products Recalled Due to Possible E. coli O157:H7 Contamination

Missa Bay, LLC, a Swedesboro, N.J. establishment, is recalling approximately 75,233 pounds of salad products that contain meat or poultry because the lettuce ingredient may be contaminated with E. coli O157:H7,  There have been 17 cases of illness and 7 hospitalizations.  The last case of illness was reported on November 1.  (list of products found here)

The salad products items were produced from October 14, 2019 through October 16, 2019. All of the product that would have been involved in the outbreak is already past the expiration date.

As part of a foodborne illness outbreak investigation, the Maryland Department of Health collected an unopened package of Ready Pac Bistro Chicken Raised Without Antibiotics Caesar Salad with FSIS EST number 18502B on the label. The state collected and tested individual ingredients in the salad and the lettuce tested positive for E. coli O157:H7.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-115-2019-release
Missa Bay, LLC Recalls Salad Products Due to Possible E. coli O157:H7 Contamination
Class I Recall
115-2019
Health Risk: High
Nov 21, 2019

Three Lots of Cheese Nips Recalled for Plastic from Misplaced Dough Scrapper

Mondelēz Global LLC is recalling three day lot codes of Cheese Nips (11 oz. Box) product in the United States due to the potential presence of small food-grade yellow plastic pieces from a dough scraper that was incorporated into the production process of a small amount of product. The company became aware of this issue when yellow plastic pieces were noticed on the manufacturing equipment.

How much will that $3 plastic dough scrapper end up costing?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mondelez-global-llc-conducts-voluntary-recall-limited-quantity-cheese-nips-11-oz-box-product-us-due
Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potential Presence of Foreign Material
Summary
Company Announcement Date: November 15, 2019
FDA Publish Date: November 20, 2019
Product Type: Food & Beverages
Reason for Announcement: Potential presence of plastic
Company Name: Mondelēz Global LLC
Brand Name: Nabisco
Product Description: Cheese Nips