Will CBD Be Classified as a Dietary Supplement?

The U.S. Food and Drug Administration (“FDA”) currently prohibits cannabidiol (“CBD”) from being added to food, beverages, or cosmetics and from being sold as a dietary supplement. While we await further guidelines from the FDA, Congressmen Kurt Schrader of Oregon and Morgan Griffith of Virginia introduced on September 4, 2020, H.R. 8179, the “Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020”, which would allow hemp, CBD, and any other hemp-derived ingredient to be sold as dietary ingredients in dietary supplements under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).  

Therefore, if H.R. 8179 becomes a law or if the FDA eventually approves CBD as a dietary supplement, then CBD manufacturers, processors, distributors, and retailers will need to ensure all of their products are in compliance with the various FDA labeling requirements for dietary supplements. 

According to the FDA, a “dietary supplement” is a product meant to supplement the diet that contains one or more of the following dietary ingredients: 

  • (A) a vitamin;
  • (B) a mineral;
  • (C) an herb or other botanical;
  • (D) an amino acid
  • (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
  • (F) a concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned described in clause (A), (B), (C), (D), or (E).

201(ff) of Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321) (as amended by the Dietary Supplement Health and Education Act of 1994). CBD seems to clearly fit under one or more of the subcategories of this definition of “dietary supplement”. 

Labeling Requirements

Three main labeling statements, along with applicable warnings (e.g., WARNING: keep this product out of reach of children), are required to be displayed on the Principal Display Panel (“PDP”). The PDP is the front display panel of the packaging and all dietary supplement CBD products require the following on their PDPs: 

  • (1) The statement of identity (name of the dietary supplement);
    • This statement of identity must include the term “dietary supplement,” except that the word “dietary” may be replaced with a description of the type of dietary ingredient(s) in the product (e.g., “herbal supplement”) or the names of one or more dietary ingredients in the product (e.g., “bee pollen supplement”).
      • The term “dietary supplement” by itself can be used as the product’s statement of identity.
    • You must use a bold and reasonable font type size to make the statement of identity the most prominent printed matter on the PDP. 
  • (2) The net quantity of contents (amount of the dietary supplement in the container or package); and
    • You must express the net quantity of contents statement in either weight, measure, numerical count, or a combination of numerical count and weight or measure.
      • When you express this quantity as a weight or measure, you must specify both metric (grams, kilograms, milliliters, or liters) and U.S. Customary System (ounces, pounds, or fluid ounces) terms. You are not to include the weight of the container, wrappers, and/or packing materials.
    • The net quantity of contents must be located within the bottom 30 percent of the PDP.
  • (3) The name and place of business of the manufacturer, packer, or distributor.1

Three main labeling statements required to be displayed on the Supplement Facts panel (located on the side of the packaging) on all CBD products would include the following: 

  • (1) Serving size and Servings per container;
    • Serving size: One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion (e.g., If 1-3 tablets are recommended with breakfast, the serving size would be 3 tablets).
    • Servings per container: Total number of servings in each container (e.g., 100 tablets).
  • (2) The nutrient declaration, which requires the following if present in a “measurable amount” (an amount that exceeds the amount that can be declared as “zero” in the nutrition label of conventional foods, as specified in 21 CFR 101.9(c)):
    • Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.
      • If present in a measurable amount, trans fat must be listed on a separate line underneath the listing of saturated fat.
      • When making a claim about calories from saturated fat, insoluble fiber, polyunsaturated fat, sugar alcohol, monounsaturated fat, other carbohydrate, and soluble fiber, you must list that nutrient.
  • (3) The ingredient list (name, quantity, and percent Daily Value of each ingredient).
    • % DV is the percent of the Daily Value of a dietary ingredient that is in a serving of the product. You must express the Daily Value percentages to the nearest whole percent. If the percent would round to zero, you put “Less than 1%” or “< 1%”.
    • You must list dietary ingredients that have Daily Values in the following order [parentheses indicate acceptable synonyms]:
      • Vitamin A, vitamin C (ascorbic acid), vitamin D, vitamin E, vitamin K, thiamin (vitamin B1), riboflavin (vitamin B2), niacin, vitamin B6, folate (folacin or folic acid), vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, and potassium.
      • You may place the amount of your dietary ingredient in a separate column or immediately following the name of your dietary ingredient.
    • Following the listing of dietary ingredients having Daily Values, you must list “Other Dietary Ingredients” (which do not have Daily Values) by common or usual name in a column or linear display.
      • FDA has not specified an order you must follow.
      • These Other Dietary Ingredients must be identified as having no Daily Values by use of a symbol in the column for “% Daily Value” that refers to the footnote “Daily Value Not Established.”
      • You must list the quantitative amount by weight per serving immediately following the name of the dietary ingredient or in a separate column.
    • Regarding “Liquid Extracts,” you must list them using the volume or weight of the total extract and the condition of the starting material prior to extraction when it was fresh.
      • You may include information on the concentration of the dietary ingredient and the solvent used, e.g., “fresh dandelion root extract, x (y:z) in 70% ethanol,” where “x” is the number of mL or mg of the entire extract, “y” is the weight of the starting material, and “z” is the volume (mL) of solvent.
      • You must identify the solvent in either the nutrition label or ingredient list.
    • Regarding “Dry Extracts” (extracts from which the solvent has been removed), you must list the weights of the dried extracts. 2

Depicted below, is a sample label of a Supplement Facts panel containing multiple vitamins:

For guidance in labeling dietary supplements, the FDA has provided its Dietary Supplement Labeling Guide as a resource. 

Label Claims

Claims made on the labels of dietary supplements present a myriad of potential issues. There are numerous types of claims that the FDA regulates, including nutrient content claims, health claims, and structure/function claims. 

Nutrient Content Claims

A nutrient content claim “expressly or by implication characterizes the level of a nutrient in a dietary supplement.” 21 CFR 101.13(b). This is different than information listed on the Supplement Facts panel. Any claims made outside of the Supplement Facts panel are considered nutrient content claims. 

Implied nutrient content claims describe the supplement or ingredient in a manner suggesting a nutrient is present or absent in a certain amount or that the supplement or ingredient may be useful in maintaining a healthy diet (e.g., “High in Oat Bran”). See id.

Express nutrient content claims are direct statements regarding the level of nutrients in a supplement or ingredient, such as “Low sodium,” “High protein,” “Contains 100 calories”. See id.

“High content disclosures” are required on labels for dietary supplements or ingredients that make a nutrient content claim AND that contain an extremely high amount of one or more nutrients per serving. Essentially, if you want to advertise the nutritional benefits of your product, then you must also disclose other nutritional characteristics that may be less desirable. 

The threshold required for making high content disclosures is as follows:

  • 13g fat per serving
  • 4.0g of saturated fat
  • 60mg of cholesterol
  • 480mg of sodium

See id. at § 101.13(h). The statement disclosing that the nutrient exceeding the specified level is present in the dietary supplement must be displayed as follows: “‘See nutrition information for __ content’ with the blank filled in with the identity of the nutrient exceeding the specified level, e.g., ‘See nutrition information for fat content.’” Id. You must place the disclosure statement immediately adjacent to the nutrient content claim with no intervening material (such as vignettes or other art work) other than information in the statement of identity or any other information that is required to be presented with the claim.

Additionally, you may find the regulations for specific claims in 21 CFR 101, Subpart D (Specific Requirements of Nutrient Content Claims) as follows:

  • §101.54(b) “High” claims
  • §101.54(c) “Good Source” claims
  • §101.54(e) “More” claims
  • §101.54(f) “High potency” claims
  • §101.54(g) “Antioxidant” claims
  • §101.56 “Light” or “Lite” claims
  • §101.60 “Calorie or Sugar” claims
  • §101.61 “Sodium or Salt” claims
  • §101.62 “Fat, fatty acids, and cholesterol” claims
  • §101.65 Implied nutrient content claims
  • §101.65(d) “Healthy” claims
  • §101.67 Use of nutrient content claims for butter

All nutrient content claims must be less than two times the size of the statement of identity but must be prominently and clearly displayed. See id. at § 101.13(f). 

Health Claims

A “health claim,” which includes “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, is an express or implied characterization of a relationship between a dietary supplement, ingredient, or nutrient and a disease or a health-related condition. See id. at § 101.14(a)(1). Health claims require significant scientific agreement AND must be authorized by the FDA. The short list of FDA-authorized health claims can be found here

Occasionally, manufacturers may put “qualified health claims” on their product labels. A “qualified health claim” is a statement approved by the FDA for use on food or dietary supplement labels that has strict wording requirements and must include an agency-approved disclaimer that discloses the level of scientific evidence used to substantiate the health claim.4

When there is emerging evidence between a dietary supplement or ingredient and the reduced risk of a disease or health condition, but not enough for the FDA to issue an authorized health claim, the FDA may approve a qualified health claim, provided that:

  1. FDA has issued a letter stating the conditions under which it will consider exercising enforcement discretion for the specific health claim;
  2. the qualified claim is accompanied by an agency-approved disclaimer [which discloses the level of scientific evidence used to substantiate the health claim]; and
  3. the claim meets all the general requirements for health claims in 21 CFR 101.14, except for the requirement that the evidence for the claim meet the validity standard for authorizing a claim, and the requirement that the claim be made in accordance with an authorizing regulation.5

For reference, a list of FDA-approved qualified health claims can be found here.

Structure/Function Claims

Dietary supplements are permitted to make structure/function claims on their labels and in their advertising. As established under the Federal Food, Drug, and Cosmetic Act, the following structure/function claims may be made if: 

  • (A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
  • (B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and
  • (C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

21 U.S.C. 343(r)(6). If a dietary supplement manufacturer or distributor intends to make a statement described in the first sentence of the above sub-paragraph (21 U.S.C. 343(r)(6)(A)), they must notify the FDA “no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.” Id.

These notifications to the FDA must be made in the following manner:

  1. Notify FDA within 30 days of first marketing a product whose label or labeling bears a statement made under section 403(r)(6) of the act;
  2. Submit an original and two copies of the notification by mail to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740 [or submit electronically through the FDA’s ePortal (COSM)]; and
  3. The notification must be signed by a person who can certify that the information in the notification is complete and accurate, and that the notifying firm has substantiation that the section 403(r)(6) statement is truthful and not misleading.

21 CFR 101.93(a)(1) and (3). The notification shall include the following information:

  • (i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement;
  • (ii) The text of the statement that is being made;
  • (iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and
  • (iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears.

Id. at 101.93(a)(2). No official form for the notification is required so long as the information detailed above is included.

Lastly, the wording of the disclaimer in 21 U.S.C. 343(r)(6)(C) cannot be modified, and it must be placed immediately adjacent to the claim with no intervening material, or elsewhere on the same panel or page that contains the statement. See id. at 101.93(d). In the latter case, the disclaimer must be placed in a box and linked to the statement by a symbol (e.g., an asterisk) placed at the end of each statement that refers to an identical symbol placed adjacent to the disclaimer. See id.

Concluding Remarks:

While the FDA continues to work towards a regulatory pathway for CBD, manufacturers and retailers must avoid making any health or drug claims and using the term “dietary supplement”; however, if H.R. 8179 becomes a law or if the FDA does eventually approve CBD as a dietary supplement, compliance with the above-mentioned FDA dietary supplement labeling regulations must be met. Additionally, dietary supplement manufacturers and own-label-distributors are required to comply with the current good manufacturing practices outlined in 21 CFR part 111.

Paul Stevenson is an associate attorney with Ritter Spencer PLLC who represents all sectors of the hemp industry, including manufacturers, distributors, and retailers of consumable hemp products. As cannabis and hemp lawyers, the lawyers at Ritter Spencer are prepared to advise your hemp or cannabis business in all facets of the industry, including formation and transactional issues and in cannabis litigation. Contact Ritter Spencer or give us a call at 214.295.5070 for more information.

  1.  Available at https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-i-general-dietary-supplement-labeling.
  2.  See id.
  3.  See 21 CFR 101.36(e)(10)(i)).
  4.  Available at https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling.
  5.  Available at https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-chapter-vi-claims#6-40; see also https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-interim-procedures-qualified-health-claims-labeling-conventional-human-food-and.

 

Ritter Spencer, PLLCWill CBD Be Classified as a Dietary Supplement?

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