FDA to Begin Tightening Down on Homeopathic Drugs

The FDA announced that will be putting more effort into enforcing regulations on homeopathic drugs.  What are homeopathic drugs?  According to the Homeopathy Center, "Homeopathic medicines – known as “remedies” – are made from natural sources (e.g., plants, minerals), and are environmentally friendly and cruelty free.  The thought is that if a natural substance causes similar symptoms, then this can be diluted and given to the patient to cure the symptoms....'like cures like'.  The example they give is this...."if you peel an onion, your eyes burn, itch and water. You might also have a runny nose and begin to sneeze. If you had similar symptoms during a cold or allergy attack, such as a runny nose, watery eyes and sneezing, a homeopathic micro-dose of the remedy Allium cepa (red onion) would help your body heal itself."

The other key for homeopathy is dilution of the natural substance...the more diluted the substance, the more potent it can be as a remedy. 'The technique for making a homeopathic medicine involves repeated dilution of a specific substance until little of the original substance remains".

Homeopathy is different than "herbal medicine, Chinese medicine, or other types of natural medicines."

FDA plans to better "address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices."

FDA News Release
For Immediate Release
December 18, 2017
Summary

FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.

Wineries Begin Seeing Surprise FDA Inspections as Part of FSMA

Many firms are seeing FDA inspections for the first time as the FSMA regulations are coming into effect, including wineries.  An article in Wine Business Magazine (December, 2017) indicates that a number of wineries are undergoing surprise FDA inspections.  For many, this may be a new experience.

From the article, "New registration and record keeping requirements for wineries under FSMA impose important changes. Wineries must now renew their FDA registration every two years.."  Wineries must also comply with GMP requirements, including the need to have documented employee training.  These firms are exempt from the the risk based preventive controls (Subpart C) and the supply chain program (Subpart G).

MA Firm Expands Recall of Smoked Fish Products After Further Testing

A Massachusetts firm is expanding its recall posted on December 13 after further testing of the environment and product.  According to the recall notice,  "The recall expansion was initiated as a result of environmental and product sampling conducted by the firm."   From this it seems that they did not have a good handle on Listeria in their environment, which for smoked seafood items, can be a real big deal.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm589893.htm
Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk
For Immediate Release
December 19, 2017

Produce Company Recalls Apples Due to Supplier's Positive Listeria Test Results

A Michigan produce company is recalling apples processed and shipped by one of its suppliers after  routine sampling program by that supplier revealed that finished products contained Listeria monocytogenes.

It seems that product was shipped prior to results coming back.  It is unknown whether the produce company was aware that the supplier had sampled product for testing.  It would seem that a test and hold procedure should have been in place.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm589722.htm
Jack Brown Produce, Inc. Recalls Gala, Fuji, Honeycrisp and Golden Delicious Apples Due to Possible Health Risk
For Immediate Release
December 19, 2017

Rattlesnake Pills Source of Salmonella Infection

Rattlesnake pills have been linked to a case of salmonelloisis in Kansas.  The pills, which were purchased in Mexico, contain dehydrated / ground rattlesnake meat and are used to treat various conditions such as HIV and cancer.  I guess when you have one of these types of diseases, why not throw some rattlesnake at it.   Sounds good, but activity against disease is probably not validated and ground snake meat, if not properly treated, may contain Salmonella.

Infection Control Today
http://www.infectioncontroltoday.com/news/2017/12/investigation-of-a-salmonella-infection-linked-to-rattlesnake-pills.aspx
Investigation of a Salmonella Infection Linked to Rattlesnake Pills

Canadian Establishment Recalls RTE Meat Products Shipped to US after Positive Salmonella Tests

A Canadian establishment, is recalling approximately 1,076 pounds of ready-to-eat salami and speck products that may be adulterated with Salmonella  These items were produced in Canada and were shipped to distribution centers in California, Illinois, Michigan, New Jersey and New York. The problem was discovered when an FSIS sample of the ready-to-eat salami product was confirmed positive for Salmonella. There have been no confirmed reports of adverse reactions due to consumption of these products.

USDA FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-129-2017-release
Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration
Class I Recall 

129-2017
Health Risk: High 

Dec 16, 2017 

Canada - Public Health Notice Issued for Romaine Lettuce Due to E. coli Outbreak

In Canada, officials are investigating 30 E.coli O157 infections with one death and twelve hospitalizations.  They are linking this outbreak to romaine lettuce.  There is no more information at this time (chopped, whole, bagged, etc).  From the report, "Many individuals who became sick reported eating romaine lettuce before their illnesses occurred. The Canadian Food Inspection Agency is working with public health officials to determine the source of the romaine lettuce that ill individuals were exposed to."

CISION
http://www.newswire.ca/news-release
Public Health Notice - Outbreak of E. coli infections linked to romaine lettuce

Import Alert Concerning Imported Frozen Tuna Steaks With Hepatitis A

FDA issued an import alert for frozen tuna steaks from Vietnam and Indonesia.   According to the import notice - " FDA believes that Hepatitis A Virus contaminated seafood is a result of insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply."

FDA Import Alert
https://www.accessdata.fda.gov/cms_ia/importalert_1157.html
Import Alert 16-137

Published Date: 12/13/2017
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF SEAFOOD DUE TO HEPATITIS A CONTAMINATION

Sliced Smoked Salmon Recalled after Listeria Positive Sample

A Massachusetts company is  recalling its 1lb. packages pre-sliced salmon because the product has  the potential to be contaminated with Listeria monocytogenes.  This issue was identified after FDA product sampling identified Listeria monocytogenes in the product.

Slicers can be difficult to clean and can become a repository for Listeria if not properly cleaned....but can also be another source within the facility from the point when the salmon is removed from the smoking units to the point where it is packaged.  While slicer cleaning should be evaluated, so to should other potential point sources in the facility.

https://www.fda.gov/Safety/Recalls/ucm588864.htm
Springfield Smoked Fish Recalls Smoked Salmon Because Of Possible Health Risk
For Immediate Release
December 13, 2017