7 Takeaways from the FDA Hearing - Mile High Labs
FDA

7 Takeaways from the FDA Hearing

By Founder and CTO, Stephen Mueller

The United States is in the midst of a hemp revolution, thanks in part to last year’s farm bill that made the plant legal again. Unlike during the days of Washington, Jefferson and Madison – when hemp’s primary product was fiber to make textiles and rope – today’s hemp is being grown to produce CBD, a non-psychoactive cannabinoid that has become one of the most talked about and least understood ingredients in the marketplace.

Last week, the Food and Drug Administration held a public hearing to determine a pathway toward regulating CBD. I had the honor and privilege to speak at this hearing and provide the following recommendations:

Don’t wait to regulate. CBD is rapidly becoming a preferred ingredient in everything from lip balm to pet food. According to a recent study by Consumer Reports, 64 million Americans have tried CBD in the past 24 months. With so many stories touting the benefits of CBD, demand is rising and so too will the supply, with some experts estimating it will “soon become a $22 billion industry.”

Simply put, the market is growing too fast and the public demand is too high for the FDA to wait to act.

FDA HearingCollage

1. START WITH LABELING REQUIREMENTS

There have been numerous reports of CBD products that are on the market that are mislabeled, and we have also seen this through our own testing of third party products. The most common issue is a discrepancy between the labeled amount of CBD and the amount that is actually in the product. More often than not, this mislabeling is a result of a lack of control by the manufacturer, which can lead to inaccurate test data or products that degrade within their shelf-life.

2. ENFORCE TESTING STANDARDS

In order to ensure that the label accurately reflects the contents of the product purchased by the consumer and the safety of the consumer, the FDA should enforce testing standards for CBD products. Right now, many testing labs lack sufficient controls to ensure the accuracy of the data. Forcing manufacturers to implement validated testing procedures is critical to improving the quality and consistency of CBD products broadly available on the market.

3. REQUIRE GMP

Good Manufacturing Practices should be the standard. These are already established for other types of products and are the only way consumers can be assured of quality and safety. By requiring GMPs, bad actors – and there are many – will either have to shape up or ship out.

4. REGULATE DIETARY SUPPLEMENTS, FOODS & COSMETICS AT LOWER STRENGTHS

 Today, with no regulation or guidance from the FDA, many manufacturers don’t understand what is required of them to produce legitimate and quality product. Consumers also don’t have confidence that the products they are buying are legitimate or which manufacturers they can trust. The FDA should regulate CBD as a dietary supplement, food and cosmetic and provide the oversight that the industry desperately needs.

5. REQUIRE NEW DIETARY INGREDIENT (NDI) NOTIFICATIONS

If the FDA accepts CBD as a New Dietary Ingredient, they should require every manufacturer to notify the FDA prior to marketing a CBD dietary supplement. In addition to including the scientific data as to why the ingredient is safe for consumption, this notification would serve as a check to ensure each and every company producing CBD products has adequate controls in place. This process is already in place for other dietary ingredients; we think it makes sense to fit CBD into this existing process to help ensure safety for the consumer.

6. EVALUATE EACH CANNABINOID SEPARATELY

Hemp contains many different cannabinoids, terpenes and other compounds. The profiles of these compounds vary from plant to plant, based on genetic and environmental factors. By evaluating each of the compounds as dietary ingredients on an individual basis, we would be better able to ensure consistency and consumer safety.

7. REQUIRE TESTING FOR CONTAMINANTS

CBD is an agricultural product, which means it has the potential to contain pesticides and heavy metals. It is critical that these harmful contaminants are kept to safe limits and that the method used to test have been demonstrated to produce accurate and precise results.

It’s not easy to regulate an industry that didn’t even exist a few years ago, and I commend the FDA for bringing together all of the stakeholders to work together toward a solution. Strong regulations enacted sooner rather than later will benefit consumers, improve the industry, and provide a strong declaration to guide this new industry into the future.

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