Industrial Hemp-Derived Cannabidiol (CBD) Products

 


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Industrial Hemp-Derived Cannabidiol Fast Facts

Click on any item in bold to get more detailed information.

  • IHDCP Plans Review Questionnaire
The plans packet is provided by the sanitarian in the region in which your business will be operating. The questionnaire provides the department with basic information about your business. Note that if you are not engaged in wholesale manufacture or distribution of IHDCP, you do not need a plans questionnaire or a permit from the Louisiana Department of Health.
  • Plumbing requirements (toilet count, grease interceptor)
Per the state sanitary code, the Certified Building Official (CBO) in your area is tasked with making most of the determinations regarding sizing and location of plumbing fixtures in your business. However, LDH does have the regulatory discretion to mandate that certain types of fixtures that are deemed critical to public health be present. For instance, even with a waiver from a local CBO, a person would not be permitted to open a food-service establishment with no hand lavatories.
  • Product registration form
The product registration application form, FD-10(N), is available for download further down this page. However, you should not simply download the form and send it to this office. The process starts with submitting label artwork for review. See the link at the top of the page to submit your artwork and supporting documents. LDH staff will review your submission along with online marketing language and materials and notify you of required changes. Once all necessary changes are made to render compliant artwork, you may submit a registration packet as directed by staff.
  • Certificates of analysis (CoAs)
One of the requirements for registering products is that the firm provide access by means of a QR code, barcode, or website URL printed on the product label, to original, per-batch certificates of analysis from a third-party laboratory for a cannabinoid profile, pesticide residues, solvent residues, heavy-metal contaminants, and microbiological contaminants. These CoAs must be from one or more laboratories that is/are accredited to the ISO/IEC 17025 standard (the current version of the rules allows certification under the 2005 revision, but the rules now under review require compliance with the 2017 revision of the standard). Note that the statutory language does not require that the testing be conducted at a specific point in the process, so if a firm wants to use a batch of bulk isolate product to create several finished products, and all of the required testing is performed on the bulk isolate and the batch is clearly identified on the finished product label and the certificate of analysis, posting that testing would meet the requirements of Louisiana law.
  • Company representation
For legal reasons, we cannot engage in discussions with individuals who are not authorized to make the necessary commitments and modifications to existing artwork or marketing materials or physical facilities in regards to registration and permitting processes for particular firms.
  • Examples of ingredients that may not be used in the formulation of IHDCP
Use of any active pharmaceutical ingredient in a cannabidiol-containing product would render said product a drug for regulatory purposes in Louisiana, and the regulatory framework to treat these products accordingly does not exist. For this reason, no quantity of any pharmaceutical ingredient in an over-the-counter or legend drug may be used as an ingredient in an industrial hemp-derived cannabidiol product.
  • Examples of impermissible medical claims or language
The statutory language in Louisiana's law specifically prohibits any kind of medical claims on products containing cannabidiol, and this includes claims that may ostensibly not be directly linked to the cannabidiol-containing ingredient. Nowhere on the physical packaging, the company's website or social media may the firm make any implicit or explicit claims that the products treat, cure or prevent any disease condition or otherwise have a structural or functional impact on the human body.
  • Responsible party name
For any type of business organization other than a proprietorship, the full firm name must be used as the responsible party name. If the products are being manufactured by a firm other than the registrant, this must be preceded by a qualifying statement such as "Manufactured for" or "Distributed by."
  • Statements of identity
The statement of identity tells a consumer what your product is; in the case of IHDCP, the term "cannabidiol" is an insufficiently-specific descriptor. If the product is an extract, isolate, or tincture, the statement of identity should reflect that. This statement is one of two that needs to appear on the part of the label most likely to be observed by the consumer when it is sitting on a shelf (this is also known as the principal display panel).
  • Net quantity of contents
The net quantity of contents must appear on the part of the label most likely to be seen by a consumer when the product is displayed on a shelf (known as the principal display panel). Statements expressed in terms of fluid measure do not require a prefatory statement, but if one is present, it must be expressed in terms of fluid measure (e.g., "Net" or "Net contents") and never in terms of weight measure (e.g., "Net wt."). For items expressed in terms of weight measure, a prefatory statement is always required. Examples of valid statements include the following: Net wt. 8 oz (227 g), Net contents 1 fl. oz. (30 mL).
  • Examples of acceptable dosage forms
Statutory language prohibits cannabidiol-containing products as foods or in forms intended for inhalation. In addition, due to the potential for confusion, LDH is not registering products such as tablets or transdermal patches that are traditionally associated with pharmaceuticals.
  • Pet products
The Louisiana Department of Agriculture and Forestry (LDAF) regulates pet foods and animal feed through its Agricultural Chemistry office. To the best of our current understanding, the legality of these items in Louisiana falls under that department's purview, and you should contact Dr. Angela Guidry (aguidry@ldaf.state.la.us or 225-925-4863) for additional information. LDH does not register these items.
  • Raw plant materials
The department has no jurisdiction over raw hemp, including hemp flowers, seeds, stems or other portions of the plant that have not been processed into an extract or isolate.
  • Acceptable forms of payment for fees
The department is currently piloting a new online payment system specifically for IHDCP registration payments. If you would prefer this option to including a cashier's check or money order with your registration packet, notify your label reviewer once your artwork has been accepted for registration. He or she will generate an invoice for your firm and direct you where to send the necessary documents once your payment is received. There is a small convenience fee charged by the third-party processor for online payments.

 

 


USEFUL ITEMS

 

  • FD-10 Application for a New Industrial-Hemp-Derived Cannabidiol Product Registration - pdf

 


REGULATIONS

 

  • Rules Addressing IHDCP Registration and Inspection - pdf

 


ITEMS ACCEPTED FOR REGISTRATION

revised 2020-12-22