FDA
POSTED BY: HEMPTODAY™ JULY 22, 2019
U.S. rules governing cosmetics, dietary supplements, food and food additives should simply be expanded to embrace hemp extracts, the trade group Hemp Industries Association (HIA) has advised the federal Food & Drug Administration.
Regulations for “the manufacturing, product quality, marketing and labeling of dietary supplements, food/food additives and cosmetics need only be augmented to accommodate hemp extract, hemp-derived CBD and other cannabinoids,” HIA said in recommendations recently submitted to the federal agency.
4,000 stakeholder responses
HIA was responding to the FDA’s recent call for input from stakeholders regarding regulation of cannabis extracts. The agency said it received more than 4,000 responses.
The FDA said it is moving quickly to develop guidance on cannabis extracts from both marijuana and hemp in light of growing interest and a boom in CBD sales.
According to HIA, rules specific to extracts need only address “cannabinoid strength and purity and (require) the labeling of (1) milligrams of CBD and primary cannabinoids per serving, (2) milligrams of CBD and primary cannabinoids per package, and (3) appropriate warnings, including urinalysis risk.”
‘No’ to synthetic CBD
The Association also called for prohibition of synthetic CBD. “HIA does not believe that synthetic cannabinoids have any place whatsoever in the human or animal diet or health care system,” the Association wrote in its recommendations.
Some American researchers have said a far-less-expensive synthetic version of CBD can be as effective in treating certain maladies as the natural version of the compound. The synthetic CBD also promises to be easier and quicker to produce.
CBD and the liver
While the Association acknowledged clinical research indicating potential effects on the human liver from high-level doses of pure CBD isolate, HIA noted generally that “potential side effects occurring at high level dosages of pure CBD do not give rise to strict regulatory control because drug-drug interactions and other safety concerns exist for various supplements and foods . . . which are commonly available at grocery stores and which concerns are mitigated by health care providers.
“Additionally, over-the-counter products like acetaminophen cause liver failure at high level dosages, ibuprofen causes gastric bleeding with over 100,000 hospitalizations and 16,500 deaths per year, and even Epsom salts cause risk of intestinal rupture,” HIA said.
Consumer protection
To further protect consumers, HIA suggested FDA:
• Use its authority to exclude hemp and derivatives from dietary supplement regulations, allowing them to be produced and sold as supplements and food additives.
• Work with the U.S. Congress to fund research about drug-drug interactions among cannabis-derived products.
• Take enforcement action against companies making medical claims and adulterated products.
• Work with industry organizations to develop proper cannabinoid analysis methods and labeling requirements covering warnings, restrictions and urinalysis risk.
FDA said the 4,000 respondents included state and local health departments, CBD manufacturers and medical organizations. HIA and another trade group, the U.S. Hemp Roundtable gathered responses from their respective members ahead of compiling the recommendations to the FDA.
https://hemptoday.net/u-s-trade-group-suggest...-extracts/
POSTED BY: HEMPTODAY™ JULY 22, 2019
U.S. rules governing cosmetics, dietary supplements, food and food additives should simply be expanded to embrace hemp extracts, the trade group Hemp Industries Association (HIA) has advised the federal Food & Drug Administration.
Regulations for “the manufacturing, product quality, marketing and labeling of dietary supplements, food/food additives and cosmetics need only be augmented to accommodate hemp extract, hemp-derived CBD and other cannabinoids,” HIA said in recommendations recently submitted to the federal agency.
4,000 stakeholder responses
HIA was responding to the FDA’s recent call for input from stakeholders regarding regulation of cannabis extracts. The agency said it received more than 4,000 responses.
The FDA said it is moving quickly to develop guidance on cannabis extracts from both marijuana and hemp in light of growing interest and a boom in CBD sales.
According to HIA, rules specific to extracts need only address “cannabinoid strength and purity and (require) the labeling of (1) milligrams of CBD and primary cannabinoids per serving, (2) milligrams of CBD and primary cannabinoids per package, and (3) appropriate warnings, including urinalysis risk.”
‘No’ to synthetic CBD
The Association also called for prohibition of synthetic CBD. “HIA does not believe that synthetic cannabinoids have any place whatsoever in the human or animal diet or health care system,” the Association wrote in its recommendations.
Some American researchers have said a far-less-expensive synthetic version of CBD can be as effective in treating certain maladies as the natural version of the compound. The synthetic CBD also promises to be easier and quicker to produce.
CBD and the liver
While the Association acknowledged clinical research indicating potential effects on the human liver from high-level doses of pure CBD isolate, HIA noted generally that “potential side effects occurring at high level dosages of pure CBD do not give rise to strict regulatory control because drug-drug interactions and other safety concerns exist for various supplements and foods . . . which are commonly available at grocery stores and which concerns are mitigated by health care providers.
“Additionally, over-the-counter products like acetaminophen cause liver failure at high level dosages, ibuprofen causes gastric bleeding with over 100,000 hospitalizations and 16,500 deaths per year, and even Epsom salts cause risk of intestinal rupture,” HIA said.
Consumer protection
To further protect consumers, HIA suggested FDA:
• Use its authority to exclude hemp and derivatives from dietary supplement regulations, allowing them to be produced and sold as supplements and food additives.
• Work with the U.S. Congress to fund research about drug-drug interactions among cannabis-derived products.
• Take enforcement action against companies making medical claims and adulterated products.
• Work with industry organizations to develop proper cannabinoid analysis methods and labeling requirements covering warnings, restrictions and urinalysis risk.
FDA said the 4,000 respondents included state and local health departments, CBD manufacturers and medical organizations. HIA and another trade group, the U.S. Hemp Roundtable gathered responses from their respective members ahead of compiling the recommendations to the FDA.
https://hemptoday.net/u-s-trade-group-suggest...-extracts/
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