In July 2018, the Florida Department of Agriculture and Consumer Services (FDACS) published the Hemp Program, which addresses a variety of topics, from contaminant safety limits to third-party testing requirements and product labeling rules. Since that time, you might be confused about the status of the program’s rules, the state’s enforcement capabilities, and whether or not they apply to your particular hemp product.
More importantly, you might not realize your hemp food or supplement is inadvertently non-compliant, which puts your brand at risk. That’s understandable as rules seem to change with the wind. But make no mistake, Florida’s hemp labeling rules are in effect NOW. Let’s review.
The Must-Knows:
Since January 1, 2020, inspectors from Florida’s Division of Food Safety have been visiting retailers every day to ensure products are compliant.
The state of Florida allows CBD extracts, despite the fact that the FDA is currently investigating them.
Non-compliant companies face risk of fines or product recalls.
* Please note, the following information applies to hemp and CBD food and supplements only, as regulated by Florida’s Division of Food Safety. Stay tuned for updates on label requirements for hemp in topical body care, tobacco, vaping or alcohol-related products.
How Does Florida Define “Hemp Extract”?
Florida defines hemp extract as a compound intended for eating or drinking that is derived from the plant and does not contain any controlled substance. According to the law, hemp extract does not include a product that contains any amount of synthetic cannabinoids.
What About Supplements?
Hemp extract products intended for human ingestion that are labeled as supplements will also be regulated by the Division of Food Safety. Supplements must adhere to all hemp extract requirements, including all hemp labeling requirements listed below.
What About CBD?
For the purposes of labeling requirements, the FDACS is considering CBD products to be synonymous with hemp extracts. While Florida is allowing CBD food and supplements, it’s important to note that the FDA does not quite agree. As of today, the FDA is still investigating CBD to determine whether or not it is safe for use in such products.
Do These Rules Apply to Me?
Florida’s hemp extract labeling rules apply to hemp and CBD food and supplements produced in the U.S., and imports that are sold in the state of Florida.
What are the Labeling Requirements?
Hemp extracts must adhere to generic food labeling requirements, along with additional rules. Below is a summary, along with links to extended resources.
Generic Food Labeling Requirements:
1. Statement of identity. The statement of identity must be listed on the front of the label, which includes the product’s name and description. A product can be referred to as a hemp extract or identified by its key cannabinoid. Florida allows brands to legally market CBD on the label as long as the product is compliant with the rules below.
2. Product weight and measurement. The product weight must be prominently featured and include both metric and U.S. measurement terms.
If the product markets specific cannabinoids such as CBD or CBN, the label must list the number of milligrams of each cannabinoid per serving. Additionally, the serving size must be displayed on the nutrition facts or supplement facts label of the product and must be declared in a volumetric measurement, such as milligrams. Examples of non-compliant serving sizes include "one dropper," "one spoonful," or "one bite."
If the product name advertises "hemp,” "hemp oil," or "hemp extract," the label does not need to state the amount of cannabinoid(s) per serving. In this situation, the law requires the number of milligrams of hemp extract per package to be declared.
3. Manufacturer, packer or distributor details. The appropriate entities’ name, address and contact information MUST be listed on the label. According to the FDACS, this is one of the most common details missing on hemp extract labels today.
4. List of ingredients (including sub ingredients). All hemp food and extracts must contain ingredient lists in order from most to least prominent.
5. Nutrition facts panel or supplement facts panel (unless exempt). Food products must display a nutrition facts panel that lists information like serving size, total calories, fat, carbohydrates, added sugars and key vitamins. Supplement facts panels have some of the same information as nutrition panels, including serving size and key vitamins, with less emphasis on calories, fat and carbohydrates. Supplement facts panels list most ingredients in the panel with other less prominent ingredients listed below.
6. Font and language. All required information on the label must be in English and legible based on the FDA’s labeling rules. Under these rules, letters must be at least one-sixteenth (1/16) inch in height.
7. Allergen or prescribed warnings. Hemp extract labels MUST include warnings about known allergens the product contains.
Labeling Rules Specific to Hemp Extracts
In addition to general food labeling rules, all hemp extract labels must contain the following additional elements.
1. Batch number. The batch number is a designation that is printed on the product that allows the history of its production to be traced. This is vital because if one product in a batch is contaminated, the entire batch must be recalled.
2. Website. The labels must include the internet address of a website where batch information can be obtained.
3. Expiration date. Many brands don’t realize it, but hemp extract labels MUST include the month and year of expiration. This can be determined by the manufacturer as long as the potency on the label remains the same throughout the product’s entire life cycle. The only foolproof way to determine this is through third-party shelf-life and stability testing.
4. Required statement. The statement below must be printed on the label verbatim. Florida law does not accept any variation to the verbiage, even if the overall meaning is the same. "Product contains a total delta-9 tetrahydrocannabinol concentration that does not exceed 0.3% on a dry-weight basis."
5. Scannable barcode or QR code. Quick response (QR) codes on the label must link directly to the Certificate of Analysis (COA) or to a website portal where the user may look up the batch number to find the COA. QR codes prove that label ingredients and potency information is accurate. They also confirm that the product is safe to use and was tested by a verified third-party laboratory. The QR code can be printed anywhere on the label as long as it does not obstruct the visibility of any other required statement.
Are All COA's Compliant?
The short answer is no. COAs are only acceptable by Florida law if a verified laboratory tested and published the results. COAs must also follow a particular format to be compliant with state guidelines:
Prepared by an independent testing laboratory.
Test results show the batch contains less than 0.3% total delta-9 THC.
Tests confirm the product does not contain contaminants unsafe for human consumption.
For contaminants such as pesticides, results can only indicate a non-quantitative result such as "ND11 not detected” or "below the limit of detection" if the report specifies what the safety limit is. The safety limit number must be clearly visible on the COA.
What Claims Can I Make on Labels?
According to the FDACS, if you are ever on the fence about making a claim, the safest bet is to air on the side of caution and leave it off the label. Unapproved health claims on the label are not acceptable and are considered misbranding. With that said, the following guidelines should help your marketing team determine the best course of action.
The label may not contain claims indicating the product is intended for the diagnosis, cure, mitigation, treatment or prevention of disease that would render it a drug.
Learn more about the do’s and don’ts of CBD claims here.
However, the FDACS indicates claims such as "helps," "supports" or "promotes" in relation to maintaining normal body functions are acceptable and allowed on hemp extract labeling. One example of a normal body function is sleep.
Can the FDACS Approve My Label Before I Print?
Unfortunately, you cannot submit a label to the FDACS for approval prior to printing and packaging the product. That said, you can follow the FDACS’s rules outlined in this blog, review extended resources, and seek advice from legal counsel. With knowledge and professional consultation, you can be confident that your hemp food or supplement product is compliant.
According to the FDACS:
The Division of Food Safety does not have labeling approval authority; however, labels will be reviewed for compliance during inspections.
It is the responsibility of the Hemp Food Establishment to meet the requirements and properly develop product labels that comply with the law.
What are the Consequences If I’m Out of Compliance?
The Florida Department of Agriculture’s cannabis director told the Sun Sentinel that inspectors are looking at what’s on shelves and giving retailers a certain amount of time to be compliant. That means they may need to throw out a lot of inventory and work with brands to relabel their products.
While we do not have any examples of enforcement as of yet, the FDACS technically has the authority to issue fines, and revoke or suspend permits of retail stores that are selling non-compliant goods. Additionally, the FDACS can go so far as to issue a stop-sale order if it finds a product in violation multiple times, and it can permanently close a food establishment.
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