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.

Has Artisanal Become the New Natural for Food Products?

In an article by Jillian Eugenios, she asks the question, “Does ‘artisanal’ even mean anything anymore?”. (http://bites.today.msnbc.msn.com/_news/2012/05/02/11503731-does-artisanal-even-mean-anything-anymore). It is in reference to a lawsuit filed against Dunkin Donuts and their new ‘artisan’ line of bagels. The lawsuit claims that this term should be limited to “products produced by hand, using traditional methods in small quantities”. My guess is that each Dunkin Donuts shop is not hand making bagels in the back of the store.

However, if I indeed want bagels made by hand in small batches, I will go to a family owned bakery. The term ‘artisinal’ in of itself, will not drive my purchase. My other guess is that the DD ‘artisanal’ bagels are probably pretty good. And if they were called by another name, say ‘really good bagels’ , they would still be pretty good bagels, regardless of the name.

And who is to decide what is ‘artisinal’? If a chain of family owned bagel shops makes bagels in the back of each store, can they call that artisanal? What if they centralize production to reduce costs and improve quality by making these same bagels in one location and then distributing them to the other shops…is this still ‘artisinal’? We have the same issue with term ‘organic’, and there are actually federal rules on what is considered, ‘organic’.

At this point, ‘artisanal’ is destined to become the new ‘natural’, or the new ‘gourmet’. We probably should spend more time on finding that quality product we like, or establishments we choose to buy from, rather than on what we call it.

Recall of Refrigerated Processed Products with the Potential for C. botulinum

It is interesting to see the same company involved in two recalls due to potential Clostridium botulinum.  In both cases, there were no illnesses, just refrigerated products that were stored at room temperature, creating the favorable growth conditions for C. botulinum.  After a further look, the olive product was first recalled due to the fact that this refrigerated product sat at room temperature for a month.  In addition to the olives, Tabatchinick Yankee Bean Soup was also recalled (this is a frozen soup product which appears to me to be higher risk since the ingredient statement does not have any secondary inhibitors).  According to the report – ‘These items have been recalled due to a lack of temperature control during the distribution process. UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer. ‘

Three days later, United Natural Foods recalled Black Bean Torillas, also due to lack of refrigeration.  This is a vacuum packed product.  If one had to guess, it was probably discovered during the investigation of the olives.

The related recalls bring attention to the concerns of refrigerated or frozen products that are not properly distributed and stored. 

Issues  

1)    Products look like shelf-stable products, so handlers may not recognize the need for refrigerated storage.

2)    Many ‘natural products’ do not have secondary inhibitors (sorbate, etc).

3)    Vacuum packaged heat processed products (black beans and possibly the soup) provide good growth conditions for C. botulinum.

As the demand increases for prepared, natural food items, we may see more cases like this.

United Natural Foods, Inc. Announces Updated Information For Recall
Related to Gentes Foods Gordita Black Bean Tortillas Due to Possible
Health Risk

http://www.fda.gov/Safety/Recalls/ucm280465.htm

Contact:
Consumer:
Lisa Madsen
401-528-8634

FOR IMMEDIATE RELEASE - November 17, 2011 – United Natural Foods, Inc. today announced a correction to its previously announced recall of selected types of Gentes Foods Gordita Black Bean Tortillas, specifically to correct the previously stated date code of 12 7 11 to the revised date code of 11 6 11. United Natural Foods, Inc. is recalling this product dated 11 6 11 because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The following product has been recalled:

GENTES FOODS 10 OZ GORDITA BLACK BEAN TORTILLAS UPC 618032102021

As previously announced, Gentes Foods Gordita Black Bean Tortillas were distributed to the Safeway and Pak N Save stores in California listed below. Our previous notification, with date code of “12 7 11” was incorrect, and product with this date code is safe to consume. The revised date code, which is on a white sticker applied to the packaging, reads “11 6 11.” These date codes sold at other retail outlets have not been affected because the products were not exposed to a lack of refrigeration controls.

SAFEWAY #1110	1546 N MAIN	SALINAS	CA
SAFEWAY #2840	2010 FREEDOM BLVD	WATSONVILLE	CA
PAK N SAVE #3116	2255 GELLERT BLVD	S SAN FRANCISCO	CA
PAK N SAVE #3125	3889 SAN PABLO AVE	EMERYVILLE	CA

Gentes Foods Gordita Black Bean Tortillas are packed as 6 tortillas in a vacuum packaged clear sleeve. The package is approximately 10oz in size and an orange label is on a clear wrapper with white lettering.

No illnesses have been reported to date.

These items have been recalled due to a lack of temperature control during the distribution process. UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer.

Consumers who have purchased Gentes Foods Gordita Black Bean Tortillas from the stores listed above with the date code mentioned should not consume these products, and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Lisa Madsen of the Company at 1-401-528-8634, Monday through Friday 9am to 5pm.

United Natural Foods, Inc. Expands Recall Of Foodmatch Inc. Divina Olives Due To Possible Health Risk

http://www.fda.gov/Safety/Recalls/ucm279855.htm

Contact:
Consumer
Lisa Madsen
401-528-8634

FOR IMMEDIATE RELEASE - November 14, 2011 - United Natural Foods, Inc. is recalling selected types of FoodMatch, Inc. Divina Stuffed Olives, because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

The following products have been recalled:

DIVINA 4 OZ OLIVES,FETA CHEESE STUFFED UPC 63172352780
DIVINA 4 OZ OLIVES,BLUE CHEESE STUFFED UPC 63172352790

Divina Olives Stuffed with Feta Cheese were distributed to the stores identified below. The date codes affected states: Best Used By: 11 JAN 2012 and Best Used By: 1 FEB 2012.

SAFEWAY #0583	1606 N AVE	SPEARFISH	SD
SAFEWAY #1577	6520 S ACADEMY ROAD	COLORADO SPRINGS	CO
SAFEWAY #1615	3325 28TH STREET	BOULDER	CO
SAFEWAY #1644	7655 MCLAUGHLIN RD	FALCON	CO
SAFEWAY #2761	1165 MAIN ST	LANDER	WY
SAFEWAY #2792	27152 MAIN ST	CONIFER	CO
SAFEWAY #2910	1632 HOVER ROAD	LONGMONT	CO
SAFEWAY #0853	7625 OLD GEORGETOWN ROAD	BETHESDA	MD
SAFEWAY #0942	12 WEST WASHINGTON ST	MIDDLEBURG	VA
SAFEWAY #1283	8646 RICHMOND HIGHWAY	ALEXANDRIA	VA
SAFEWAY #1606	9596 OLD KEENE MILL RD	BURKE	VA
SAFEWAY #1668	5510 NORBECK ROAD	ROCKVILLE	MD
SAFEWAY #1956	14939 SHADY GROVE ROAD	ROCKVILLE	MD
SAFEWAY #2650	43150 BROADLANDS PLAZA	ASHBURN	VA
SAFEWAY #4002	5727 BURKE CENTER	BURKE	VA
SAFEWAY #4205	415 14TH STREET SE	WASHINGTON	DC

Date codes Best Used By: 11 JAN 2012 and Best Used By: 1 FEB 2012 sold at other retail outlets have not been affected because the products were not exposed to a lack of refrigeration controls.

Divina Olives Stuffed with Blue Cheese were distributed to the following states: Alaska, Washington, Oregon, California, Arizona, Nevada, South Dakota, Colorado, Wyoming, Maryland, Pennsylvania, Virginia, and Washington DC through the following retail stores: Genuardis, Carrs, Safeway, Pavilion and Vons. The following date codes were affected:

Best Used By: 11 JAN 2012, Best Used By: 15 DEC 2011, Best Used By: 30 DEC 2011, Best Used By: 1 FEB 2012

These date codes sold at other retail outlets have not been affected because the products were not exposed to a lack of refrigeration controls.

Divina Feta Cheese Stuffed Olives are packaged in plastic 4oz cup containers with a blue and yellow label.

Divina Blue Cheese Stuffed Olives are packaged in plastic 4oz cup containers with a blue label.

No illnesses have been reported to date.

These items have been recalled due to a lack of temperature control during the distribution process. UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer.

Consumers who have purchased FoodMatch Inc. Divina Feta Cheese Stuffed Olives, or FoodMatch Inc. Divina Blue Cheese Stuffed Olives should not consume these products and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Lisa Madsen of the Company at 1-401-528-8634, Monday through Friday 9am to 5pm.

FoodMatch Details UNFI Recall

http://www.prnewswire.com/news-releases/foodmatch-details-unfi-recall-133630808.html

NEW YORK, Nov. 10, 2011 /PRNewswire/ -- The FDA announced that United Natural Foods, Inc. (UNFI) Recalls Divina Olives. FoodMatch Inc. recommends that the following products be withdrawn from the market to ensure the safety and health of our customers.

United Natural Foods, Inc. (UNFI) is recalling:

·        7 cases of 4 oz. refrigerated deli cups of Divina Olives stuffed with Feta Cheese with a best by date 11JAN2012 sold exclusively to Safeway stores in Colorado, South Dakota, and Wyoming

·        46 cases 4 oz. refrigerated deli cups of Divina olives stuffed with Blue cheese with best by dates 11JAN2012, 15DEC2011, and 30DEC2011 sold exclusively to Carrs, Safeway, Pavilion, and Vons stores in Alaska, Washington, Oregon, California, Arizona, Nevada , South Dakota, Colorado, and Wyoming

The above 53 cases are the only Divina products affected by this recall.

As noted in the FDA alert, "UNFI inadvertently subjected the recall items to temperature ranges above those directed by the manufacturer." No illnesses have been reported to date.

The Quality Assurance Manager at FoodMatch Inc. is Ms. Jari Buechler and can be reached at 212.244.5050 for additional information.

http://www.oregonlive.com/health/index.ssf/2011/11/blue-cheese_stuffed_olives_sol.html