Updated Exemption for CBD Sales

Summary of Requirements for CBD and “Nutritional Supplements”

There are four main issues related to compliance and enforcement:

 

1.    Florida requires all “business entities” (practices, retailer, etc.), whose business has MORE than 12 linear feet of merchandizing shelves  that sells/resells ingestible Hemp Extract/CBD product(s) to pay for and maintain an active Food Permit, specifically a Hemp Food Establishment Permit: Cost $650 annually.   See the Fl Statute Here

2.    Any business whose merchandizing space is less than 12 linear feet is EXEMPT from Food Permitting requirements and fees. 

3.    Any business selling ingestible Hemp Extract products should understand and verify that those products comply with FL labeling requirements for CBD products.  

4.    Additional, inspection and permitting requirements apply to “entities” making/preparing/manufacturing CBD products for wholesale or retail purposes. That info is available in the hyperlinked text below as well.  

Because one government employee may not know all the laws relating to Licensed Acupuncturists practice and if you qualify for the “less than 12 linear feet” exemption FSOMA recommends you print and keep in your office the statute related to this exemption. To qualify the total shelf space dedicated to nutritional supplements (not patches or lotions) must not exceed 12 linear feet. 

Click here to View FL statutes

Click here to view it

Click Here 

 

Summary of the New Florida Laws Effective 01/01/2020

There are two main issues related to compliance and enforcement:

1. Florida requires all “entities” (people, practices, retailer, etc.) selling/reselling any CBD product(s) to pay for and maintain an active Food Permit, specifically a Hemp Food Establishment Permit: Cost $650 annually and you are responsible for making certain that whatever products you sell comply with FL labeling requirements for CBD products.  
2. Additional, inspection and permitting requirements apply to “entities” making/preparing/manufacturing CBD products for wholesale or retail purposes. That info is available in the hyperlinked text below as well.  

Most of the statutory language and rules describing the selling and labeling requirements for CBD in FL – refer to regulations for Hemp and Hemp products to be ingested as a food defined in section 500.03 FS, which reads:

(n) “Food” includes:

1. Articles used for food or drink for human consumption;
2. Chewing gum;
3. Articles used for components of any such article;
4. Articles for which health claims are made, which claims are approved by the Secretary of the United States Department of Health and Human Services and which claims are made in accordance with s. 343(r) of the federal act, and which are not considered drugs solely because their labels or labeling contain health claims; and
5. Dietary supplements as defined in 21 U.S.C. s. 321(ff)(1) and (2).

The statutes are less clear on non-edible products, like lotions, creams, gels – things containing multiple ingredients, additives and excipients.  But I would recommend following the same labeling and batch monitoring practices for both.   

So, any CBD Extract product being sold or offered in Florida must comply with each of the labeling requirements listed below.  I can’t find  specific language that describes enforcement/discipline for anyone selling products that don’t meet this standard – but it’s most certainly a violation of Commerce or Agriculture laws in the State and comes with penalties. .  

FS Statute 581.217 – [Florida] State Hemp Program

Section 7 speaks to retailing Hemp Products: 

(7) DISTRIBUTION AND RETAIL SALE OF HEMP EXTRACT.—Hemp extract may only be distributed and sold in the state if the product:

(a) Has a certificate of analysis prepared by an independent testing laboratory that states:

1. The hemp extract is the product of a batch tested by the independent testing laboratory;
2. The batch contained a total delta-9-tetrahydrocannabinol concentration that did not exceed 0.3 percent on a dry-weight basis pursuant to the testing of a random sample of the batch; and
3. The batch does not contain contaminants unsafe for human consumption.

(b) Is distributed or sold in packaging that includes:

1. A scannable barcode or quick response code linked to the certificate of analysis of the hemp extract by an independent testing laboratory;
2. The batch number;
3. The Internet address of a website where batch information may be obtained;
4. The expiration date;
5. The number of milligrams of hemp extract; and
6. A statement that the product contains a total delta-9-tetrahydrocannabinol concentration that does not exceed 0.3 percent on a dry-weight basis.

These are the requirements for ANYONE selling/retailing hemp extract products in Florida. 

It’s also helpful to look at FL Dept Agriculture FAC “Hemp Extract” Final Rule effective 01/01/2020.  

Section 
5K-4.034 Hemp Extract

1. Products. Hemp or Hemp Extract intended to be ingested is a Food as defined in Section 500.03, F.S., and are subject to the requirements of Chapter 500, F.S., and Rules 5K-4.002; 5K-4.004; 5K-4.020; 5K-4.021, and 5K-4.035, F.A.C., in addition to the requirements of this rule.

Pay attention to ALL Sections 1, 2, 3, 4, 5 and 6.  These include details that are important related to Permitting and product third-party testing/analysis – this is the Florida standard that you will be held to, so make certain the products you sell or make are tested and reported to be free of the contaminants and pesticides listed.  It’s all very specific from the State.  

Read and be familiar with all these statutory definitions and Rules in listed above in BOLD.

Some answers to some questions 

1. Does the 12’ shelving Food Permitting exemption/requirement apply to shelving in the common area of the business only; or, do storage areas count toward the 12’ allowance. 

ANSWER: Retail only. Storage in a back room is not counted. 

2. Some practitioners have a dispensary in the office where either raw or granulated herbs are stored.  These raw herbs or granules are not typically for resale “as is” but they are “commercially prepackaged, not potentially hazardous, and not time or temperature controlled for safety.”  It’s not unusual for a practitioner to maintain an inventory of 60-100 separate herb/mineral/other ingredients that the exceed 12’ shelving.  These items are portioned, combined and dispensed to make individual formulas for patients to brew or otherwise ingest at home.  Is the storage area for these items considered “shelf space” in the office, if this space is not used for retail “display” purposes.

ANSWER: If the raw materials are being sold and displayed in public they count towards the 12 feet.  

3. Hemp Seed (cannabis sativa L) is recommended and used in Chinese herbal medicine practice in Florida, known by the name Hou Ma Ren.  How is ingestible Hemp Seed regulated in FL and is it subject to the new labeling requirements?

ANSWER: Hemp Seeds usually are seen as a GRAS item (Generally Recognized As Safe).  However, FL SB 1020 did not give GRAS items an exemption.   We have a bill in the process this session to try and correct that.  So hemp seeds fall under the same rules and law as CBD.