FDA regulations for CBD in food and beverages may be just around the corner, according to recent CBD headlines. Agency officials from the US Food and Drug Administration recently announced plans for publishing their recommendations on CBD as a novel food ingredient citing concerns over long-term consumption. However, FDA regulations have yet to be seen.
Table of Contents
The news has seemingly put producers and investors on edge as stock prices of US-list companies dropped between five and nine percent.
The History of FDA Regulation
Although many producers wince when the topic of FDA regulation comes up, as a consumable product, regulation is necessary. While conspiracy theorists and anti-taxation comments proliferate in the public comments surrounding this news, it is important to note that rules play an essential role in the future of the industry, especially for consumables.
Food safety rules have been enacted since before the US became an independent country. Early American colonists established rules as early as 1646 that forbade bakers from using ground peas or beans in bread. GMP practices exist for a reason and without FDA regulation, few make the effort.
Why Consumer Transparency is Vital
Then, in 1785, early American leaders signed the Massachusetts Act Against Selling Unwholesome Provisions, which became the first food safety law in the US. However, as the industrial revolution of the 19th century progressed, and populations climbed, manufacturers needed ways to preserve food without refrigeration.
Deborah Blum, author of, The Poison Squad: One Chemist’s Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, said, “[Food] wasn’t safety tested because there were no rules requiring that. It wasn’t labeled because there were no rules requiring that anyone tell you what was in your food. And it wasn’t illegal even if you killed someone.”
A few of the items she wrote about included,
- Manufacturers added copper to make vegetables appear greener.
- Dairy producers used Borax as a preservative in butter.
- Butter may not have been butter at all; it may have been beef tallow or dyed ground-up cow stomach.
- Spices often contained coconut shells, charred rope, brick dust, and floor sweepings.
- Dyed corn syrup was sold as “honey.”
- Pureed calf brains were used to make milk look like cream.
- Formaldehyde was often used as a preservative in milk and meat, leading to many children’s illnesses and even deaths.
Federal Food, Drug, and Cosmetics Act of 1938
The laws we have established today for food and drug production weren’t just put there arbitrarily to make life more difficult for producers or to collect tax from consumers. A simple Google search can reveal a number of atrocities that led to these rules and regulations for manufacturing consumable products.
Let History Provide the Lessons
Laws must change and adapt as new products, scenarios, and dangers enter the market. That was never so evident as it was in 1937. According to a paper written by Carol Ballentine in 1981, a simple raspberry elixir and ignorance led to the deaths of more than 100 people, including small children.
According to the story, sulfanilamide was a drug commonly used to treat strep infection during this time. It had been used safely in tablet and powder form, but a salesman for S.E. Massengill Co. requested a liquid form of the drug, so chemist and pharmacist Harold Cole Watkins began experimenting with different solvents to satisfy consumer demand.
After finding a solvent that worked, the new elixir was control-lab tested for flavor, appearance, and fragrance – but not safety or toxicity – because the active ingredient was already assumed safe. And 633 shipments were shipped out all over the country.
Unfortunately, the solvent Watkins used to dissolve the drug was diethylene glycol, a chemical used as antifreeze which is fatal when ingested. This incident prompted one of the FDA’s most extensive drug retrieval efforts in history. But fearing reprimand, many doctors, pharmacists, and salesmen involved in dispersing the elixir, refused to help authorities, leading to dozens of unnecessary deaths.
The paper also noted that the existing scientific literature had already established that diethylene glycol was toxic and could cause kidney damage or failure. But laws in 1937 did not prohibit selling dangerous, untested, or poisonous drugs.
The owner of the company, Dr. Samual Evans Massengill, showed no remorse with this public statement, “My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand, and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”
But Harold Watkins, the chemist who created the elixir, committed suicide due to the incident and the harm he caused. FDA regulations are now in place to help prevent such tragedies from reoccurring.
Why We Need FDA Regulation: The Problem with CBD Production – Isn’t the CBD
Although not quite as severe, we’ve seen similar incidents in the hemp and cannabis space. Without FDA regulation, manufacturers and producers could be unwittingly putting consumers at risk or simply taking advantage of unsuspecting buyers.
When hemp is grown, a natural process known as phytoremediation helps the plant absorb the nutrients and minerals it needs to survive and thrive. But, in addition to the beneficial compounds that hemp absorbs from the soil, it also absorbs heavy metals, contaminants, and toxins. These potential dangers do not magically disappear, they are stored in the plant’s leaves, stems, and flowers, and when processed and extracted, they can easily find their way into consumable products.
Without FDA regulation, there are no laws to enforce safety standards or testing, or they may vary from state to state.
In December 2017, the Utah Poison Control Center reported numerous ER visits associated with a product labeled CBD. By January, 52 people had become ill, and it had been traced to a product called “Yolo CBD oil.”
When analyzed, it was uncovered that the product didn’t contain CBD at all. Instead, it was made with a chemical known as 4-cyano CUMYL-BUTINACA, or 4-CCB, a synthetic cannabinoid. The report states that symptoms of the products included an altered mental state, nausea, vomiting, seizures, and involuntary shaking.
Naturally, we cannot discuss contaminated products without bringing up the EVALI Crisis of 2019. More than 2,000 people became sick with a lung disorder now known as e-cigarette vaping use-associated lung injury.
An additive used to make the vaping oils more viscous for the devices, Vitamin E acetate, is thought to be the cause of these injuries. While the substance is approved for use and generally recognized as safe for food products, it has not been evaluated for safe inhalation.
Mislabeled Snake Oil
Another common misconception among consumers is that if a product is professionally packaged and labeled, it must be tested and legitimate. Unfortunately, many consumers are finding out the hard way that just simply isn’t the case.
Without FDA regulation, hemp producers are not “required” to test for anything. Lab shopping and test alterations are commonplace in the industry. While some states have enacted some rules for industrial hemp production, standards in testing for potency and safety simply don’t exist. THC and CBD content can be tested differently from one lab to the next, so accurate and honest labeling is difficult to discern.
FDA Regulation Doesn’t Hinder Good Business; It Enables It
Let’s face it, human nature isn’t always trustworthy. When profits can be increased through deception, someone will take advantage of the loopholes to make an extra buck. While the intent may not be nefarious, it isn’t exactly forthcoming.
Hopefully, FDA regulation helps ensure that all manufacturers follow the same production, testing, and labeling rules. Standards not only help ensure consumer safety, but they also help weed out unethical producers who cut corners to get ahead of producers who are following the rules.