December 23, 2014

Stanton A. Glantz, PhD

Flavor manufacturers warn companies that breathing heated flavors can be dangerous; relevant to e-cigs

E-cigarette companies and the people who support them love to point out that the flavors used in e-cigarettes are "generally recognized as safe" (GRAS).  The GRAS definition applies to ingested (eaten) not inhaled (breathed) use of these chemicals. 
 
In fact, the Flavor and Extract Manufacturers Association of America (FEMA), the organization which assigns most of the GRAS designations, specifically warns its members to ensure that workers are protected from inhaling flavors while working with them.  In its 32 page guide, Respiratory Health and Safety in the Flavor Manufacturing Workplace, it recommends that the following two signs be posted where people are working with flavors:
 

WARNING – This flavor may pose an inhalation hazard if improperly handled. Please contact your workplace safety officer before opening and handling, and read the MSDS [material safety data sheet].  Handling of this flavor that results in inhalation of fumes, especially if the flavor is heated, may cause severe adverse health effects.

 

ATTENTION - Safe flavors can be used in an unsafe manner. Please contact your workplace safety officer before opening and handling this flavor, and read the MSDS.

 
FEMA goes on to highlight the special dangers of inhaling heated flavors and how ventilation is not a solution.  (This is important not only for e-cigarette user safety but also speaks to why e-cigarettes should be included in clean indoor air laws.)
 

Heating of flavors

Heating of flavors is of particular concern with regard to potential hazardous exposures. Heating will increase volatility and greatly increase air concentrations of  flavoring substances. Mixing of heated flavors should be conducted in closed vessels with local ventilation. Workers should not open heated vessels to conduct visual inspections in such a way as to create an opportunity for exposure. In instances when workers must work near open vessels that are heated and cannot be closed or do not have local ventilation, their exposures should be promptly evaluated by environmental sampling. If exposures are elevated then the proper personal protective equipment should be employed.
 
Ventilation

Flavoring substances and mixtures, whether liquid or dry, must be handled in such a way as to minimize the creation of airborne aerosols or particulate matter. This means that mixing, blending, and other physical manipulation activities should be performed in closed systems when possible. When systems must remain open, local (“spot”) ventilation (e.g. “elephant trunks”) should be used. Fume hoods are commonly used in research and development laboratories. Dilution through general room ventilation seldom results in exposure reduction unless extremely high volumes of air are circulated. [emphasis added]
 

In addition to being of concern to people using e-cigarettes and bystanders breathing the secondhand heated aerosol, these issues should be of particular concern to people working in and visiting vape shops.
 
The whole GRAS process, by the way, is not an effective way to protect the public from potentially dangeous flavors.  I used to think that the FDA was who identified flavors are "generally recognized as safe" (for ingestion), but it turns out that the flavor industry awards GRAS designations to itself through a process that is rife with conflicts of interest. 
 
Thomas Neltner and colleagues published a searing analysis of the current self-voluntary system, " Conflicts  of interest in approvals of additives to food determined to be generally recognized as safe: out of balance," in JAMA Internal Medicine in 2013.  Here is the abstract of their paper:

 
IMPORTANCE:  Food and Drug Administration (FDA) guidance allows food manufacturers to determine whether additives to food are "generally recognized as safe" (GRAS). Manufacturers are not required to notify the FDA of a GRAS determination, although in some instances they notify the agency. The individuals that companies select to make these determinations may have financial conflicts of interest.
 
OBJECTIVE: To determine the extent to which individuals selected by manufacturers to make GRAS determinations have conflicts of interest between their obligations to ensure that the use of the additive is safe and their financial relationships to the company. DESIGN Using conflict of interest criteria developed by a committee of the Institute of Medicine, we analyzed 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012.
 
MAIN OUTCOMES AND MEASURES:  Number of GRAS notices submitted to the FDA; frequency of various types of relationships between decision maker and additive manufacturer; frequency of participation on GRAS panels by individuals; and number of GRAS safety determinations identified by the FDA that were not submitted to the agency.
 
RESULTS: For the 451 GRAS notifications, 22.4% of the safety assessments were made by an employee of an additive manufacturer, 13.3% by an employee of a consulting firm selected by the manufacturer, and 64.3% by an expert panel selected by either a consulting firm or the manufacturer. A standing expert panel selected by a third party made none of these safety assessments. The 290 panels that made GRAS determinations had an average of 3.5 members, with a maximum of 7. Ten individuals served on 27 or more panels; 1 individual served on 128 panels (44.1%). At least 1 of the 10 individuals with the most frequent service was a member of 225 panels (77.6%).
 
CONCLUSIONS AND RELEVANCE:  Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.

 

Comments

Comment: 

The tobacco industry used the GRAS argument for years about the additives it put in cigarettes. Of course it was bogus there too, and for much the same reasons:
  http://publishing.cdlib.org/ucpressebooks/view?docId=ft8489p25j&chunk.id... title="http://publishing.cdlib.org/ucpressebooks/view?docId=ft8489p25j&chunk.id......
  http://www.jeffreywigand.com/WHOFinal.pdf" title="http://www.jeffreywigand.com/WHOFinal.pdf";http://www.jeffreywigand.com/...
I'm struck by how much of Big Tobacco's playbook the e-cigarette industry is using today: pushing laws that look good ("not for kids!") but are actually ineffective and freeze out effective policies; funding "studies" that find the product harmless; recruiting customers to lobby for the industry; cries over how it doesn't want kids to use its product; fighting the science on the secondhand effects of its product; aggressive marketing with obvious kid appeal that resembles cigarette ads from Big Tobacco's glory days; paid celebs hawking the product; candy flavor products that it pretends are attractive only to adults; even specific talking points, like calls for "sensible" regulation, code for weak regulation; and yep! the GRAS claim, back again, almost unchanged. So many pages out of the same playbook, you could imagine it's 1990, or even 1970, and it's Philip Morris, and they're here to help you!
Of course, the e-cigarette industry is increasingly the tobacco industry. So perhaps this isn't too surprising.
Jon Krueger
 

Comment: 

 
This: May and Wigand, 2005, “The Right to Choose: Why Governments Should Compel the Tobacco Industry To Disclose Their Ingredients" is another very decent review of the issue by Dr Wigand plus colleague on the issue of GRAS. It is a great shame that even some "experts" in the UK for example are currently claiming that Propylene Glycol is GRAS. It is, in many areas even including some inhalers, but it has yet to be shown as such in ENDS, where the solvents are heated to 100-150oC, and subsequently are demonstarting the ability to produce carbonyls in volumes as high as we see produced in tobacco (as per Dr Farsalinos, for example). It should be these folks, according to Wigand and May, who advise the public as to what really happens to "GRAS ingredients" when they are used in E-cigs, but too many are steering clear, which could obviously cause mis-information to parents and youth.
Happy New Year.
 
Dave Bareham

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