Herbal Supplements Questioned: Fighting Bad Practices with Bad Science?

This past week, the NY Attorney General accused major retailers (Walmart, Target, Walgreens and GNC) of selling herbal supplements that do not contain the herbs claimed on the label and issued a cease-and-desist letter demanding they stop selling those products.

Testing of the supplements was conducted using DNA barcoding, a technique that uses specific DNA sequences  to look for markers that indicate a specific plant species.  This technique has had much success in determining  animal and plant material authenticity and inclusion of potential adulterants.

However, these techniques work best on material where the DNA is likely to be there intact.  As pointed out by the critics of this investigation, many of the herbal supplements sold are highly processed, and this processing may degrade the DNA to a point where it will not be detected.

In DNA barcoding of medicinal plant material for identification (Techen, etal 2014 Current Opinion in Biotechnology Volume 25, Pages 103–110):

The isolation of pure, high molecular weight DNA is critical for the successful application of molecular methods. This can be quite a challenge since in processed medicinal plant material the DNA is often highly degraded or the plant material contains high amounts of polysaccharides, polyphenols and other secondary metabolites, such as, alkaloids and flavonoids. Various commercial kits and modified traditional methods are available to yield in good quality DNA from raw and powdered medicinal plant material, herbarium specimens, capsules, tablets, or tinctures for downstream applications 

In  DNA barcoding as a new tool for food traceability (Galimberti et al. 2013, Food Research International Volume 50, Issue 1,  Pages 55–63):

DNA is normally more resistant to industrial processes than other molecules, such as proteins (Martinez et al., 2003), and DNA fingerprinting methods can be successfully used in identifying animal or plant materials, even when in small traces (Bottero and Dalmasso, 2011, Costa et al., 2010, Kesmen et al., 2007, Mane et al., 2009, Martin et al., 2009 and Soares et al., 2010). Nonetheless, food processing causes chemical and physical alterations, degradation and fragmentation being the most common effects (Bauer, Weller, Hammes, & Hertel, 2003). DNA integrity largely influences the effectiveness of molecular methodologies (Hellberg and Morrisey, 2011, Meusnier et al., 2008 and Pafundo et al., 2007). DNA barcoding can have two advantages if compared to DNA fingerprinting approaches: i) it requires the amplification of a short DNA fragment (hence there is a lower risk of fragmentation), and ii) it is based on mitochondrial or plastidial genome (more preserved during processing).

 

The supplement industry is not regulated as a food or drug, but has its own regulations.  These rules are lax compared to those for drugs in that these products do not need to have FDA approval before selling on the market, and those claims do not necessarily need to stand to the same standard as a drug.  FDA requires that the herbal supplements are safe and that the ingredients listed on the label be in the product.  There is however, still the question whether these products actually have  any significant impact on health.

From the National Institutes of Health website:

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists for standardization in the United States as it applies to botanical dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.

In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of their dietary supplements. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.

Like other dietary supplements, botanicals are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various botanical ingredients varies widely. Some botanicals have been evaluated in scientific studies. For example, research shows that St. John's wort may be useful for short-term treatment of mild to moderate depression. Other botanical dietary supplements need more study to determine their value.

The dietary supplement industry has estimated sales of $6 billion, part of a $13 billion dietary supplements industry.  This investigation, while questionable in terms of methodology, may trigger further investigation into whether or not the dietary supplement industry is following questionable practices.

CBS/APFebruary 8, 2015, 3:59 PM
http://www.cbsnews.com/news/herbal-supplements-industry-lashes-out-at-fraud-claims/
Herbal supplements industry lashes out at fraud claims

ALBANY, N.Y. - DNA barcoding has exposed some infamous cases of food fraud, like cheap catfish sold as pricey grouper and expensive "sheep's milk" cheese that was really made from cow's milk.

But can it tell if a pill touted as an energy-booster contains ginseng or is just a mix of rice powder and pine?

Some scientists say yes, while industry groups and some independent experts say DNA testing alone is inadequate for analyzing botanical products that have gone through a lot of processing from leaf to tablet.

More Raw Meat Pet Food Recalled

 J.J. Fuds of Indiana is recalling pet food which was frozen raw meat product due to the fact that Salmonella and Listeria was found in the product. No illnesses have been reported (for people or pets).

What do we expect....it's raw meat.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm433312.htm
J.J. Fuds, Inc. Expands Recall of Pet Food Because of Possible Health Risk

Contact:  Consumer:  888-435-5873
 Media:  Karl Gottschlich  (888) 432-5873

FOR IMMEDIATE RELEASE – February 4, 2015 – Valparaiso, IN – J.J. Fuds in Valparaiso, IN is expanding their recall to include all lots and products of J.J. Fuds Chicken Tender Chunks, Beef Tender Chunks and Duckling Tender Chunks Pet Food because it has the potential to be contaminated with Listeria monocytogenes and or Salmonella, organisms which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Senator Suggests Regulations Requiring Handwashing Not Needed

A NC Senator thinks that it should not be the governments job to have regulations requiring handwashing in food service operations. 

There are some dumb regulations, but regulations such as this that set a minimum bar for food safety,  in this case, requiring food service employees to wash their hands, is.....good.  Why would someone pick such a poor example to fight overregulation...perhaps he is not a handwasher and this is the example that first comes to mind when he thinks about deregulation.  Wouldn't want to eat at his house.

For a good sound mocking, we have this Daily Show clip.
http://thedailyshow.cc.com/videos/yikssr/mr--unclean


Charlotte Observerhttp://www.charlotteobserver.com/2015/02/03/5491207/sen-tillis-maybe-restaurants-shouldnt.html#.VNJyck10x9A
Sen. Tillis: Maybe restaurants shouldn’t require hand-washing

Posted: Wednesday, Feb. 04, 2015

Congressional Republicans are challenging several health regulations, with one senator suggesting restaurants shouldn’t have to make their employees wash their hands after bathroom visits.

Such restaurants would have to prominently disclose their decision, and then would probably would go out of business, said newly elected GOP Sen. Thom Tillis of North Carolina. But they should have that choice, he said.

Macadamia Nuts Recalled Due To Salmonella Positive Sample

Whole Foods is recalling raw macadamia nuts after an FDA contract laboratory found a sample of the product to be positive for Salmonella.

Macadamia nuts are often eaten raw.  The processing is fairly simple - Dehusking, drying, de-shelling, and further drying to a moisture level of 1.5%.  Contamination can occur from the point when the nut is de-shelled until when it is packaged.

There have been a number of recalls of macadamia nuts due to Salmonella (Nov 1, 2014, 2010 and 2009).

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm432870.htm
Whole Foods Market Recalls Raw Macadamia Nuts from Stores in AL, GA, MS, NC, SC and TN Due to Possible Health Risk

Contact: Consumer: 512-477-5566 ext. 20060

Media Contact: Darrah Gist Darrah.Gist@wholefoods.com

FOR IMMEDIATE RELEASE — February 3, 2015 — ATLANTA, GA — Whole Foods Market is recalling packaged raw macadamia nuts due to possible Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Chicago Firm Recalls RTE Chicken Tamale Product Due to Lack of LM Control Program

A Chicago firm is recalling cooked chicken tamale product (considered RTE) because the product was produced in a facility that did not have a Listeria control program as well as a HACCP plan for this type of product.

From the recall notice (below), it appears that this company packed raw product.  They can not begin to run cooked product without establishing a Listeria Control program to prevent contamination that can occur in the post-lethality environment (areas where product is exposed after cooking and prior to packaging).  Listeria is likely to be found in a raw meat facility.  Before someone would begin packing a cooked product, they would need to put controls in place, otherwise, it is likely to contaminate the cooked product

One could guess that the co-packer in this case, had an opportunity to sell cooked product, but did not go through the proper steps necessary, including developing a HACCP plan for that product, which would have included a hazard analysis.  In that hazard analysis, Listeria would be identified as a hazard likely to occur.  From there, the facility would put control measures in place to prevent the contamination of the fully cooked finished product.


USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-014-2015-release-update
Illinois Firm Recalls Chicken Products Produced Without Adequate Ready-To-Eat HACCP Plan and a Listeria Monocytogenes Program
Class I Recall 014-2015
Health Risk: High Jan 17, 2015
Distribution List PDF
En Español

Congressional and Public Affairs  Whitney Joy   (202) 720-9113

WASHINGTON, Jan. 17, 2015 – La Guadalupana Wholesale, Inc., a Chicago, Ill., establishment, is recalling approximately 8,856 pounds of chicken tamales because they were not produced under a fully implemented Ready-To-Eat (RTE) Hazard Analysis & Critical Control Points (HACCP) plan; a Listeria monocytogenes (Lm) program; and a hazard analysis, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Georgia Firm Recalls Pecans Due to Salmonella

A small Georgia firm is recalling pecan products after the state of Georgia tested and found product to be positive for Salmonella.

The recall was limited to one lot.  This would indicate that it was a lot specific issue in the heating step (blanching or roasting).  If this step was adequate, that would indicate an environmental issue.  If that were the case, one may expect to have contamination across multiple lots and then consideration would be made for recalling multiple lots.

As we know, Salmonella is an issue with nut products.  One reason is that the organism survives for long periods of times in dry environments, such as seen with typical nut roasting operation.  The other issue is that Salmonella has an increased heat resistance in the dry state.  While 160F or 165F is sufficient for eliminating Salmonella in beef or poultry, according the GMA Handbook for Safe Processing of Nuts (pg 40), temperatures of 180F - 190F are needed for blanching, while roasting requires temperatures greater than 248F.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm432479.htm
Georgia Company Recalls Certain Pecan Products Due to Possible Health Risk

Contact: Consumer: 770-207-6486

FOR IMMEDIATE RELEASE — January 30, 2015 — Atlanta, Ga. — Georgia Agriculture Commissioner Gary W. Black is alerting Georgians to the recall of certain pecan products for potential health risk. The products were distributed only in the State of Georgia, directly to consumers at the retail level from the Stone Mountain Pecan Company, located in Monroe.

Ohio Firm Recalls Salami Due to Inadequate Cooling.

Updated 2/4/15

An Ohio firm is recalling salami products after it was determined that the cooling step in the process appears to have had a deviation in that the product was not cooled enough. This facility operated under state jurisdiction but participated in the Cooperative Interstate Shipment (CIS) program. Under CIS, state-inspected plants can operate like a federally-inspected facility by meeting specific conditions, and then ship their product in interstate commerce and internationally.

The hazard of concern for meat cooling is Clostridium perfringens.    FSIS has requirements that must be met for cooling (also called stabilization) which are defined in Appendix B.

Clostridium perfringens is a sporeforming pathogen that can exist in soil, water, food, meat, spices and vegetables.  The spores are heat resistant and can survive cooking temperatures such as process for cooking processed meat products (Dvalue at 212F ranges from 0.7 min to 38.4 min). If present in the raw materials, the numbers are very low, if present at all.  It only becomes a risk if the cooked product is temperature abused where the number of organisms reach a high number.  It divides very fast in the 90F to 115F range (can be as fast as every 10 minutes or less).

The symptoms of the illness occur within 6 to 24 hours after eating the contaminated food and these symptoms include diarrhea and acute abdominal pain.  The illness occurs when the food contains large numbers of bacteria, that once consumed, sporulate in the intestines and thus releasing the toxin.  Toxin can also be preformed in the food.

It is interesting to note that this is a cured meat, and being a cured meat, Clostridium pathogens are controlled by nitrite.

Dr. Bruce Tompkin provided a comment on this topic, which I wanted to add here:

 

This recall reminds me of the long, unfinished debate about whether C. perfringens is a significant hazard and for that reason chilling should be a CCP in the HACCP plan for cooked cured meat products.

This recall also is unfortunate because it is not likely to have any public health benefit because cured meats have not been associated with C. perfringens illness with one notable exception.

That exception is corned beef that has been cooked in water in a home or food service establishment and subsequently held at time-temperatures that permit germination and outgrowth. Long cooking in water likely reduces the salt and nitrite levels to non-inhibitory levels.

Otherwise, “there is no history of C. perfringens diarrhea associated with cured meat products since the bacillus is relatively sensitive to sodium chloride and nitrite” (ICMSF Book 5. 1996. page 116). Similar statements can be found elsewhere in the literature.

We investigated chilling deviations and conducted other research to better understand why the risk of C. perfringens illness from commercially processed RTE meat and poultry products is very low (Kalinowski et al. 2003. JFP 66:1227-1232). That research investigated both cured and non-cured products.

The publications of Jackson et al in 2011 (JFP 74:410-416 and 417-424) are among the more recent studies that lead to the conclusion that C. perfringens should not be considered a significant hazard in “conventionally cured” meats.

The risk assessment by Crouch et al in 2009 (JFP 72:1376-1384) led to the conclusions that ”Improper retail and consumer refrigeration accounted for the majority of the predicted C. perfringens illnesses, while stabilization accounted for less than 1% of illnesses. Therefore, efforts to reduce illnesses in RTE/PC meat and poultry products should focus on retail and consumer storage and preparation methods.” This agrees with experience in the UK and Australia as mentioned in Kalinowski et al. 2003.

Yes, cooked cured products are now chilled faster and more orderly but I do not recall any instance of C. perfringens illness occurring from an improperly chilled cured RTE product between 1964 when I started in the industry, 1988 when the initial chilling guidelines were implemented and 1999 when FSIS finalized its stricter chilling/stabilization regulations.

Bruce Tompkin


 FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-024-2015-release
Ohio Firm Recalls Salami Products Due To Possible Temperature Abuse
Class I Recall 024-2015
Health Risk: High Jan 30, 2015
Congressional and Public Affairs Whitney Joy (202) 720-9113
 
WASHINGTON, Jan. 30, 2015 – Great Lakes Smoked Meats, a Lorain, Ohio establishment, is recalling approximately 2,863 pounds of smoked salami product, which may have experienced temperature abuse and may contain Clostridium perfringens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

USDA Proposes Salmonella and Campylobacter Performance Standards for Poultry Parts and Ground Poultry

 USDA has proposed setting performance standards for poultry processors on raw ground poultry as well as raw poultry parts (breasts, legs, breasts and wings). A performance standard for pathogens is a level of positive samples a facility can have. USDA then tests product at the facility to see whether they are in compliance. This puts pressure on the facility to put measures in place to reduce the prevalence of pathogens thus having a positive impact on safety.

USDA performance standards are in place for whole poultry, but as with the Foster Farms outbreak, numbers can increase during further processing such as cutting into parts or grinding. And these products, ground and parts, represent a big proportion of the product people buy.

These performance standards will allow some level of Salmonella and Campylobacter to still be present, but in lowering the level there, the USDA hopes to reduce the number of illnesses that occur.  That being said, it still important the people handle chicken in a way to prevent cross contamination and cook it to eliminate pathogens that may be present.

USDA News Release
 http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=2015/01/0013.xml
Release No. 0013.15
Contact: Office of Communications (202)720-4623
USDA Proposes New Measures to Reduce Salmonella and Campylobacter in Poultry Products
New Standards Could Help Prevent an Estimated 50,000 Illnesses Annually

WASHINGTON, Jan. 21, 2015 -- The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) today proposed new federal standards to reduce Salmonella and Campylobacter in ground chicken and turkey products as well as raw chicken breasts, legs and wings. Development of these new standards is a major step in FSIS' Salmonella Action Plan, launched in December 2013 to reduce Salmonella illnesses from meat and poultry products.

Food Warehouses - Get Ready for Some Scrutiny

Senator Chuck Schumar (D-NY) is pushing for increase regulatory attention to food warehouses due to reported unsanitary conditions in food warehouses, including rat nests, litter and other forms of untidiness.  Case in point was a warehouse in Pennsylvania, operated by a NY firm (FDA Warning Letter below), where they found rat nests, dead rats, rodent feces, and a number of other sanitary issues.

External warehouses, along with transporters (to be tackled by the transportation component of FSMA) are all part of the food chain, but have not received as much attention as the processing component - processing facilities and connected/internal warehouses.  For the food system to be safe, all components of that chain must utilize food safety practices.  Unfortunately, some of these ancillary services have not had the level of attention that they should have had.   One exception being where the warehouse had to meet 2nd party or 3rd party inspection requirements.


Think Progress
http://thinkprogress.org/health/2015/01/12/3610616/schumer-fda-inspections/
Senator Pressures FDA To Crack Down On ‘Disgusting’ Warehouses That Supply Our Food

by Sam P.K. Collins Posted on January 12, 2015 at 11:57 am Up

Last year, the Food and Drug Administration (FDA) cited squalid conditions in 90 warehouses, including a Chinese food distributor that the agency found to have rodent nests, carcasses, and feces littering in its warehouse during an inspection in December.

That’s why Sen. Chuck Schumer wants the regulatory agency to up the ante and crack down on food manufacturers that cannot maintain sanitary spaces for food production. He’s calling for more frequent inspections, higher fines, and the creation of an easily searchable food database for distributors and consumers.