Views: 69 Author: Site Editor Publish Time: 2020-10-15 Origin: Site
FDA allows big company Heat stick labels to boast “reduced exposure” though not “reduced risk”.
big company heat-not-burn cigarette product can now sport carefully worded label information hinting at reduced health risk but not claiming it directly.
On Tuesday, the FDA announced it had OK’d labels for three big brand herbal sticks (one plain, two menthol) with language stating they reduce exposure to harmful chemicals. But the agency also noted that it rejected big company request for a separate “reduced risk” designation, saying “the evidence did not support [it] at this time.”
The products were initially OK’d in April 2019 without allowing any claims of improved safety. Also last year, the agency allowed Swedish Match to market its “snus” snuff packets as modified risk tobacco products.
The agency emphasized that it does not “approve” tobacco products and does not consider them safe; it merely authorizes them for marketing under legislation enacted in 2009.
Allowing the “exposure modification” claims for the heat not burn products means that the FDA agreed they are “expected to benefit the health of the population as a whole” in comparison with conventional cigarettes.
“In particular, the agency determined the company demonstrated that because the Tobacco Heating System heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke,” the FDA said.
“Furthermore, studies showed switching completely from combusted cigarettes to the Tobacco Heating System significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals. The toxicological assessment also found that, compared with cigarette smoke, aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems. Additionally, the FDA found that the applications supported the required consumer understanding findings.”
Big company is required to conduct additional postmarketing studies to assess effects on “consumer perception, behavior and health,” the agency added. These include studies of youth use.