DNA Testing of Herbal Supplements Show Some Pose Unacceptable Health Hazards

February 16, 2015

New York Attorney General Eric T. Schneiderman announced that his office sent letters to four major retailers, GNC, Target, Walmart, and Walgreens, for allegedly selling store brand herbal supplement products in New York that either could not be verified to contain the labeled substance, or which were found to contain ingredients not listed on the labels. The letters call for the retailers to immediately stop the sale of certain popular products, including Echinacea, Ginseng, St. John’s Wort, and others. Attorney General Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place.

The letters come as DNA testing, performed as part of an ongoing investigation by the Attorney General’s Office, allegedly shows that, overall, just 21% of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels—with 79% coming up empty for DNA related to the labeled content or verifying contamination with other plant material. The retailer with the poorest showing for DNA matching products listed on the label was Walmart. Only 4% of the Walmart products tested showed DNA from the plants listed on the products’ labels.

“This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements,” said Attorney General Schneiderman. "The DNA test results seem to confirm long-standing questions about the herbal supplement industry. Mislabeling, contamination, and false advertising are illegal. They also pose unacceptable risks to New York families—especially those with allergies to hidden ingredients. At the end of the day, American corporations must step up to the plate and ensure that their customers are getting what they pay for, especially when it involves promises of good health.”

“As the sponsor of a measure that would require labeling that states whether a product has been evaluated by the FDA or not, and legislation to establish a dietary supplements safety committee, I fully support the Attorney General's efforts in this area,” said New York State Senator Ken LaValle. “ I will continue to fight for legislation that will provide adequate labeling information for the public.”

“Since 2005, I have sponsored legislation to create a dietary food supplements safety committee,” said New York State Assembly member Felix Ortiz. “This bill was crafted for the very same reasons the Attorney General is now targeting retailers selling generic supplements that may or may not contain the substances contained on the labels. I support the Attorney General’s efforts and I will continue to push for the passage of my bill (A3548) to help reduce this kind of consumer fraud. We need adequate standards and better enforcement over these dietary supplements so consumers will feel confident knowing what they are buying.”

“The evidence for these herbs' effectiveness is sketchy to begin with," said David Schardt, Senior Nutritionist of the Center for Science in the Public Interest. "But when the advertised herbs aren't even in many of the products, it’s a sign that this loosely regulated industry is urgently in need of reform. Until then, and perhaps even after then, consumers should stop wasting their money. Attorney General Schneiderman has done what federal regulators should have done a long time ago.”

“This study undertaken by Attorney General Schneiderman’s office is a well-controlled, scientifically-based documentation of the outrageous degree of adulteration in the herbal supplement industry,” said Arthur P. Grollman, M.D., Professor of Pharmacological Sciences at Stony Brook University. “I applaud the New York Attorney General for taking the additional step of seeking to remove these products from the marketplace as they can cause serious harm to consumers unaware of the actual ingredients in the pills and capsules they ingest. Hopefully, this action can prompt other states to follow New York’s example and lead to the reform of federal laws that, in their current form, are doing little to protect the public.”

Using DNA barcoding technology to examine the contents of herbal supplements, the Attorney General’s investigation is focused on what appears to be the practice of substituting contaminants and fillers in the place of authentic product. The investigation looked at six different herbal supplements sold at the four major retail companies in thirteen regions across the state, including Binghamton, Brooklyn, Buffalo, Harlem, Nassau County, Plattsburgh, Poughkeepsie, Rochester, Suffolk County, Syracuse, Utica, Watertown, and Westchester County.

The testing revealed that all of the retailers were selling a large percentage of supplements for which modern DNA barcode technology could not detect the labeled botanical substance.

While overall 21% of the product tests confirmed DNA barcodes from the plant species listed on the labels, 35% of the product tests identified DNA barcodes from plant species not listed on the labels, representing contaminants and fillers. A large number of the tests did not reveal any DNA from a botanical substance of any kind. Some of the contaminants identified include rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot, and others. In many cases, unlisted contaminants were the only plant material found in the product samples.

The US Food and Drug Administration requires companies to verify that their products are safe and properly labeled for their contents, but unlike drugs, supplements do not undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug—from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.

If the producers of herbal supplements fail to identify all the ingredients on a product’s label, a consumer with food allergies, or who is taking medication for an unrelated illness, is taking a potentially serious health risk every time a contaminated herbal supplement is ingested. The Attorney General's investigation is focused on potential violations of New York's General Business Law and Executive Law, including deceptive practices and deceptive advertising.

An expert in DNA barcoding technology, Dr. James A. Schulte II of Clarkson University in Potsdam, New York, was hired by the Attorney General’s office to perform the testing. DNA barcodes are short genetic markers in an organism’s DNA and are used to identify it as belonging to a particular species. Barcodes provide an unbiased, reproducible method of species identification. Barcodes can be used to determine the exact plant species being tested.

The DNA tests were performed on three to four samples of each of the six herbal supplements purchased from the New York stores. Each sample was tested with five distinct sequence runs, meaning each sample was tested five times. Three hundred and ninety tests involving 78 samples were performed overall.

How to Implement OSHA’s Globally Harmonized Hazard Communication Standard (GHS)

OSHA has issued a final rule revising its Hazard Communication Standard, aligning it with the United Nations’ globally harmonized system (GHS) for the classification and labeling of hazardous chemicals. This means that virtually every product label, safety data sheet (formerly called “material safety data sheet” or MSDS), and written hazard communication plan must be revised to meet the new standard. Worker training must be updated so that workers can recognize and understand the symbols and pictograms on the new labels as well as the new hazard statements and precautions on safety data sheets.

 

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Reynolds Nationwide Exposes Workers to Dangerous Fumes, Fined $179,000

Employees at Reynolds Nationwide risked potentially lethal suffocation caused by dangerous fumes as the company did not test the atmosphere and properly ventilate the air in food transport tankers before allowing workers to enter. After receiving an employee complaint, OSHA initiated an investigation on August 6, 2014, at the London, Ohio, tank-cleaning facility.

 

"Fumes can reach dangerous levels in confined spaces, and that puts workers in real and immediate danger," said Deborah Zubaty, OSHA's area director in Columbus. "Reynolds Nationwide failed to implement training and procedures to protect workers entering these tanks, and that is unacceptable."

OSHA's investigation found that Reynolds did not ventilate the tankers to eliminate and control atmospheric hazards and failed to test and monitor the atmospheric conditions in the tankers before allowing workers to enter and clean them. 

A willful violation is one committed with intentional, knowing or voluntary disregard for the law's requirement, or with plain indifference to worker safety and health.

OSHA regulations require that the atmosphere in a confined space must be tested for oxygen, combustible gases, toxic gases, and vapors. Steps must also be taken to ensure the atmospheric conditions are safe before a worker enters the space. A confined space is one large enough for workers to enter and perform certain jobs, such as cleaning a food transport tanker, but it has limited or restricted means for entry or exit and is not designed for continuous occupancy.

The agency determined that Reynolds Nationwide failed to develop a confined space entry permit program to include training workers on hazards, procedures for summoning emergency services and providing monitors when an employee entered a confined space. Electrical safety violations were also noted. 

An OSHA violation is serious if death or serious physical harm could result from a hazard an employer knew or should have known exists.

 

OSHA Fines Saia Motor Freight Line $119,000 after Explosion Injures 4 in St. Louis

Four employees were hospitalized, two of them critically injured, after an explosion at a St. Louis trucking terminal on August 6, 2014. The explosion's cause: a forklift's ignition source and a loose coupling connection to a liquid propane gas tank.  As a result, the agency has proposed penalties of $119,000.

Both a 54-year-old lead forklift operator and a newly hired 25-year-old worker, who had used propane forklifts for about a month, received critical burns. A third worker suffered burns to his legs as he helped extinguish his colleagues' burning clothing. A fourth employee, who was using his forklift near the flash fire, was also burned.

"Workers must be trained to avoid deadly combinations of flammable fuels, ignition sources and confined spaces, which allow vapors to ignite quickly," said Bill McDonald, OSHA's area director in St. Louis. "This incident should remind all employers that using forklifts is one of the hazards workers may face daily."

Inspectors found several powered industrial trucks with defective or bypassed safety switches being used when they were in need of repairs, resulting in a willful violation.

 OSHA found that Saia did not evacuate the work area after the release of the flammable gas; require the exchange of forklift propane containers in an adequately ventilated area; mount gas containers on the cylinder indexing pin correctly; train workers on extremely flammable gas hazards; and require the use of hand and eye protection when changing cylinders. Additionally, hazardous chemicals in the maintenance shop were not labeled. The company also failed to train powered industrial truck operators, and several electrical safety hazards were noted.

Based in Duluth, Georgia, Saia has 147 terminals covering 34 states and Canada. It employs approximately 8,000 workers. There are three operating service groups: Saia LTL, Saia Truckload Plus and Saia Logistics Services. The company has about 150 employees at the St. Louis terminal who perform cross-dock operations.

Formed Fiber Technologies Fined $108,800 for Exposing Employees to Lacerations, Amputation, and other Hazards

Employees at Formed Fiber Technologies, LLC's, Auburn, Maine, manufacturing plant use a variety of machines, including robots, to make polyester carpets, and thermoformed trunk liners for the automotive industry. An inspection by OSHA begun in September 2014, has found these workers at risk of injuries because their employer did not ensure proper safeguards on the machines they operate.

"Formed Fiber Technologies employees in Auburn face the risk of lacerations, crushed fingers, amputation or worse if struck by or caught in unguarded or unexpectedly activated machinery," said Maryann Medeiros, OSHA's area director for Maine. "Some of these hazards are similar to those found in previous OSHA inspections. Formed Fiber is responsible for effectively correcting all of these hazards once and for all."

 The company also failed to review a representative sampling of employees to make sure they understood and followed lockout/tagout requirements. These hazards were similar to those cited by OSHA in 2013 at the company's Sidney, Ohio, production facility.

Also, robots used to trim trunk liners during the production process had the capability of reaching beyond their safety perimeters and striking the robots' operators or other nearby employees. Other hazards involved lacerations, finger injuries, or amputations because employees could come in contact with operating parts of looms, a grinder, and a drill press.

As a result of these conditions, OSHA has cited Formed Fiber Technologies for two repeated and five serious violations of workplace safety standards. The company faces a total of $108,800 in proposed fines. 

A repeated violation exists when an employer has been cited previously for the same or a similar violation of a standard, regulation, rule, or order at any other facility in federal enforcement states within the last five years.

SVEP focuses on recalcitrant employers that endanger workers by committing willful, repeat, or failure-to-abate violations. Under the program, OSHA may inspect any of the employer's facilities if it has reasonable grounds to believe there are similar violations. 

Gateway Extrusions Again Exposes Workers to Amputation, other Hazards

 OSHA cited one repeated and eight serious safety and health violations at the Union facility, with proposed penalties of $63,000.

"Lack of worker protections at this facility exposed workers to serious and life-altering injuries," said Bill McDonald, OSHA's area director in St. Louis. "Gateway Extrusions has a responsibility to protect workers from known hazards at its jobsite, and the number of violations there demonstrates a lack of commitment to that obligation."

An OSHA inspection in October 2014 found that two operating machines, including a sander and multipurpose press in the fabrication area, lacked proper safety mechanisms, which exposed workers to amputation and other serious hazards. The company was cited for a similar violation at this facility in 2013.

Workers also were exposed to unguarded platforms and floor openings, electrical hazards, and unsecured shelving and storage units. 

Seaboard Foods Fined $51,000 for Exposing Workers to Corrosive Chemical

Seaboard Foods, LLC, of Guymon, Oklahoma, was recently cited for exposing workers to dangerous chemicals. 

Seaboard Foods, a pork-processing facility, operates two anhydrous ammonia refrigeration systems.  Some of the violations cited include failing to:

  • Provide written operating procedures addressing safety systems and function
  • Develop and implement safe work practices to control hazards during operations
  • Train workers involved with operating procedures involving the anhydrous ammonia process
  • Inspect and test process equipment to maintain its mechanical integrity
  • Three violations are being cited for fall, electrical, and machine guarding hazards.

"The safety of a worker's skin, eyes and lungs should never be taken lightly," said David Bates, OSHA's area director in Oklahoma City. "Anhydrous ammonia is corrosive and if it's not properly controlled it puts workers at risk. Employers who deal with highly hazardous chemicals like these have a responsibility to implement effective process safety management programs, because the release of toxic, reactive, or flammable liquids and gases can be catastrophic."

Northstar Contracting Group Inc. Exposes Workers to Falls

The investigation was initiated on October 7, 2014, after a compliance officer with OSHA observed imminent danger fall hazards while workers performed tree-trimming activities from an aerial lift.

The company was cited for one willful violation for failure to provide fall protection for an employee working from an aerial lift. OSHA also cited one serious violation for an employee working on the ground in the vicinity of overhead tree trimming who was exposed to struck-by hazards from falling tree limbs, or head injury due to the lack of a protective helmet. Northstar Contracting Group, Inc., was fined $53,900 for these violations.

"It is no secret that falls are the leading cause of work-related fatalities, and the risk of falling is magnified for those working from aerial lifts during tree-trimming operations. This company's failure to protect its workers from falls and other safety hazards is inexcusable," said Kris Hoffman, director of OSHA's Parsippany Area Office.

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