H.B. 8179 | CBD DIETARY SUPPLEMENT REGULATIONS 2021
If you haven’t already heard, we are exceptionally excited to share with you that House Bill 8179 (H.B. 8179) is back in front of the house, following a brief withdrawal at the request of the incoming administration!
What is H.B 8179?
H.B. 8179 is legislation proposing that hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug, and Cosmetic Act (FDCA) as a dietary ingredient in a dietary supplement. This bill has bipartisan support and is expected to pass both the house and senate very shortly!
What does this mean for the industry?
Proper regulation of the hemp industry is hugely important both from the consumer perspective and the industry perspective. For consumers, this means an increase in consumer confidence in the safety and efficacy of hemp products in general.
As an industry, we finally will have a legal framework within which to work. These regulations will also serve to contract the industry itself, squeezing out those players who either cannot or do not intend to follow the law; in short, those who remain, will be the reputable – ensuring that your customers receive only safe and efficacious hemp products.
What regulations will impact our industry?
Upon the categorization of hemp products as dietary supplements, a body of regulations will impact the entire life cycle of these products – everything from claims substantiation, how raw materials are sourced, manufacturing processes, how consumer complaints are handled, what we can say in advertising, how records are kept, to how products are returned. The bodies of regulations that govern dietary supplements, and soon, CBD as well, are The Dietary Supplement Health and Education Act of 1994 (“DSHEA”), the Food, Drug, and Cosmetic Act (FDCA), the Food Safety Modernization Act (FSMA), and the Federal Trade Commission Act (FTCA). The laws work together like this:
- The FTCA of 1914 established the Federal Trade Commission and outlaws unfair methods of competition and unfair acts or practices that affect commerce.
- FDCA is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics.
- DSHEA is a 1994 statute which defines and regulates dietary supplements. Under DSHEA, supplements are effectively regulated by the FDCA.
- In 2011, the FDCA was amended to include FSMA, which requires facilities to create and implement safety plans and to register their facilities.
What does this mean in practical terms?
Let’s take a deeper dive into how these regulations translate into operations:
Operations: Current Good Manufacturing Practices (cGMPs) (FDCA – 12 CFR Part 111)
Who: You are subject to cGMP’s if you manufacture, package, label, hold or distribute a dietary supplement.
What: cGMP’s are the minimum requirements for methods used in or controls used for the manufacture, processing, packing, or holding of a dietary supplement to assure its safety, identity, strength (efficacy), quality, and purity.
cGMP’s provide regulatory requirements for the following operations:
- General Requirements
- SUBPART A: General Provisions
- SUBPART B: Personnel
- SUBPART C: Physical Plant & Grounds
- Specific Requirements
- SUBPART D: Equipment & Utensils
- SUBPART E: Production & Process Controls (PPC)
- SUBPART F: Quality Controls
- SUBPART G: Components, Packaging, Labeling, and Received Product
- SUBPART H: Master Manufacturing Records
- SUBPART I: Batch Production Records
- SUBPART J: Laboratory Operations
- SUBPART K: Manufacturing Operations
- SUBPART L: Packaging and Labeling Operations
- SUBPART M: Holding & Distribution
- SUBPART N: Returned Dietary Supplements
- SUBPART O: Product Complaints
- SUBPART P: Records & Record Keeping
Facility Registration: FSMA (21 U.S.C. Part 301)
Who: You are subject to FSMA requirements if you manufacture, package, label, hold or distribute a dietary supplement.
What: Each activity has different requirements, but if you warehouse and/or distribute dietary supplements, you are required to register your facility with the FDA and be prepared for FDA inspections to ensure that you are compliant with the cGMP’s and that your products are properly labeled.
Product Labeling: FDCA (21 CFR Part 101)
Who: Any company listed on the finished dietary supplement label as the Distributor is required to ensure compliance with applicable labeling requirements.
What: Labeling requirements are generally broken into 3 sections:
- The Principal Display Panel (the front label)
- The Supplement Facts Panel (the part of the label that lists the ingredients)
- Information Panels (parts of the label include directions for use, warnings, distributor information, etc.)
Each of the sections of the label has requirements related to:
- Content requirements
- Type-Size requirements
- Content placement requirements
Advertising: FTCA (15 U.S.C. §§ 41-58)
Who: You are subject to FTCA requirements for advertising if you market and/or sell dietary supplements.
What: The FTC and the FDA work together to ensure that only lawful claims are made about dietary supplements within advertising. This means that dietary supplements are prohibited from making claims that are not truthful or are misleading to an average consumer.
Additionally, dietary supplements are prohibited from making claims that they will diagnose, treat, prevent, mitigate, or cure any disease.
Dietary supplements are allowed to make what are referred to as “structure/function claims”– this means that the claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.” General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient.
Consumer Complaints: Current Good Manufacturing Practices (cGMPs) (FDCA – 12 CFR Part 111 Subpart O)
Who: You are subject to cGMP’s if you manufacture, hold or distribute a dietary supplement.
What: The FDCA considers some types of consumer complaints to be considered product quality complaints and sets forth requirements for companies to investigate and document these complaints accordingly. The purpose of these requirements is to identify any potential failures within the manufacturing or distribution processes so that potentially dangerous products may be recalled quickly, thus limiting endangerment of consumer safety. Companies involved in the manufacture and distribution of dietary supplements need to have a comprehensive program for product quality complaint management in place.
How do we make sure we’re compliant?
The great news is that Joy Organics was founded on the critical tenet of compliance. You can trust that all of Joy Organic’s operations are fully compliant with these regulations (already!) so you know that the product you receive from Joy is safe, efficacious, and trusted by our Private Label and Wholesale partners as well as your consumers.
Additionally, Joy’s internal compliance staff will work with you to ensure your product labels are in compliance with all applicable regulatory requirements.
Finally, Joy Organics also offers a resource list to its partners. This list includes trusted resources of all sorts, but also includes contacts to support your compliance initiatives.
If you have any questions regarding these regulatory requirements and how we comply, please don’t hesitate to reach out to us. Thank you for being a great part of the Joy Organics family!
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