Not only would legislation reduce the power wielded by the FDA and establish guidance for CBD manufacturers, it would ultimately guarantee the customer’s safety.
The FDA has chosen to maintain the standard of accepted dietary supplements by throwing out the possibility that cannabidiol compounds can be used as active ingredients or supplements in foods and beverages.
The Farm Bill
The Farm Bill legalizes the cultivation of hemp plants in the United States. CBD is derived from hemp. This law which was passed in December 2018 was an effort of the previous government to improve agriculture in the country. While the legislation permits the growing of hemp, it also prohibits the sale of hemp products without FDA approval.
All brands being marketed and regulated as a drug cannot be sold or labeled as food, beverage or dietary supplement except the FDA approves it.
The FDA’s Position
For many years, even before the approval of the Farm Bill, the Food and Drug Administration (FDA) has taken a position that opposes the inclusion of cannabidiol compounds in food production.
This position was reaffirmed in July, when the agency vetoed two dietary ingredients that tested positive for CBD compounds. The FDA was notified that the New Dietary Ingredients (NDI) had full-spectrum hemp extracts that also contained cannabidiol.
The FDA linked the cannabidiol contained in these products to the active ingredient used in an approved prescription drug called Epidiolex. This drug was approved by the FDA for the management of seizures in Lennox-Gastaut syndrome patients. It can also be used to treat patients diagnosed with Dravet syndrome. The FDA argues because CBD has previously been studied and marketed by GW Pharmaceuticals with its Epidiolex drug, it can no longer be accepted as a dietary supplement ingredient.
The FDA also claims that the manufacturers of these products failed to prove that the CBD extracts failed to meet the conditions of use that state that products must be reasonably expected to be safe.
The companies marketing these dietary ingredients were subsequently contacted and told that their products would not be entering into the mainstream market because these ingredients failed to meet the definition of dietary supplements provided by the food and drug administration.
The companies involved were Charlotte’s Web, product ID; NDI 1199, and Irwin Naturals with product ID; NDI 1202. The agency wrote that both companies did not include enough evidence to relieve the agency’s significant concerns over consumer’s safety.
In the letter, the agency mentioned that the data provided by Irwin Naturals is not related to their product. Instead, the information referred to phytocannabinoid mixtures.
The FDA wrote that Charlotte’s Web failed to give substantial proof to show that NDI 1202 induces no adverse effects in the consumer.
Two years ago, Commissioner Scott Gottlieb, head of the agency then, explained that the singular way cannabis or cannabis-derived product can be marketed as or in a dietary supplement is if it is FDA approved. He stated that is a criminal act for manufacturers to include CBD in foodstuff or dietary supplement without proper regulations. The FDA must first regulate the product through its notice-and-comment rulemaking process. The company has to present the agency with evidence of benefit that would be sufficient to review present CBD conclusions.
Some months ago, the FDA showed an interest in creating a pathway for cannabis and cannabis-related products to be approved. Nothing significant has been said or done about it. Recent happenings point that the FDA is not switching sides anytime soon, except the legislation is changed by the congress.
CRN Extremely Disappointed By FDA Decision
As expected, the affected parties did not receive the news well. The Council For Responsible Nutrition (CRN) is a body that is recognized as “the official trade association for dietary supplement and functional food industry in the country”. The headquarters of this council is based in Washington.
On August 11, the council responded saying that the FDA is guilty of mislabelling the rejected products. The president and chief executive officer of the association explained that the FDA did not consider the evidence put forward that explained how the products could be used safely.
According to CRN CEO & President, Steve Mister, the FDA dismissed and downplayed information that could have moved the products forward. The administration has failed to reason that full-spectrum hemp products can also be used and marketed in a manner that is best for human consumption.
Mister also added that the agency has still not done anything substantial enough to ensure the majority of consumers are against the products from the unregulated marketplace. He made sure to add that the market became unregulated due to the inaction of the Food and Drug Administration over the last two years.
Could The Judgment Of The FDA Be Flawed?
Mister claims that the FDA wrongfully equated the ingredient extracts to Epidiolex.
From the laboratory tests carried out on Epidiolex and the full spectrum extracts, it was observed that the first contains around 10 times more cannabinoids than the latter.
The FDA’s findings were incorrect; Epidiolex is a more potent substance because it contains highly concentrated CBD isolates.
The CEO of Charlotte’s Web, Deanie Elser, pointed out the skewed reasoning of the FDA, he added that the agency’s decision further proves that Congress must take immediate steps to provide regulatory clarity on the use of CBD in dietary supplements.
The Hemp And Hemp-derived CBD Consumer Protection And Market Stabilization bill was introduced earlier in May to legislate hemp CBD as a dietary supplement. Another proposed measure is the Hemp Access and Consumer Safety Act. Both bills are still being circulated among the senators and Reps. Reports have it that Senate Majority Leader Chuck Schumer is currently drafting another bill to this effect.
The FDA’s refusal to change its position on this issue has become frustrating to the affected parties.
For the agency to stop issuing these NDI objection letters, congress has to swiftly approve legislation that would legalize the use of a certain amount of CBD in dietary supplements.
Like Charlotte’s Web wrote, not only would legislation reduce the power wielded by the FDA and establish guidance for manufacturers, it would ultimately guarantee the customer’s safety.