PCB Tutorial
Lesson 4 — Coding Food, Food-Related, Cosmetic and Vitamin Products
On This Page
- Glossary
- Vitamin, Mineral, Protein, and Unconventional Dietary Specialty Classes
- Vitamin, Mineral, Protein, and Unconventional Dietary Specialty Subclasses
- Vitamin, Mineral, Protein, and Unconventional Dietary Specialty Process Indicator Codes
- Check Your Knowledge
- Code the Products
Vitamin, Mineral, Protein, and Unconventional Dietary Specialty Products — Industry Code 54
Vitamin, Mineral, Protein, and Unconventional Dietary Specialty products are covered under Industry Code 54. The tables below provide Class, Subclass, and Process Indicator Codes (PIC) codes commonly used for products covered under Industry Code 54. There is a unique set of Subclass codes for these products that provide different codes based on whether the product is for: Human Food Use, Human Drug Use, or Animal Use.
- Dietary supplements are limited to products taken orally (ingested/absorbed via the gastrointestinal tract) for human use. [21 U.S.C. §321(ff)].
- Dietary supplement products may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases [21 U.S.C. §343(r)(6)].
- The dietary supplements label must include "Supplements Facts" with a list of Dietary Ingredients (often called a Supplements Facts panel). Other ingredients, such as gelatin, starch, stabilizers, etc. must be listed below the Supplements Facts section of the label as "Other Ingredients."
- For other Human "Food and Food-Related Products" or "Miscellaneous Food-Related Items" — use Industry Codes 02-50 or 52. See Lesson 4 - Industry Codes 02-50 or Industry Code 52 for more details.
- Drug: A product is considered a drug if the label or labeling contains claims that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or that it is other than a food that will affect the structure or function of the body [21 U.S.C. §321(g)]. For human and animal drugs that are not within the scope of Industry Code 54, use Industry Codes 55, 56, 58, and 60-66. See Lesson 5 - Pharmaceutical Necessities and Containers.
- Animal Use Products: For Animal Use products that fall under Industry Code 54, use Animal Uses Subclass codes (L, M, N, R). Supplements for animals are regulated as either foods or drugs depending on labeling, ingredients, and intended use. For animal use products that are not within the scope of Industry Code 54, use Industry Codes 55, 56, 58, and 60-72. Most animal foods should be coded under Industry Codes 69-72, when possible. See Lesson 5 - Industry Code 55, Industry Code 56, Industry Code 58, and Industry Codes 60-66 for drugs, drug products, and biologics. See Lesson 6 - Coding Animal Use Products for Industry Codes 67 and 69-72 (Type A medicated articles and animal foods).
Product Coding Tips:
- NEW: The Food and Drug Administration (FDA) will be retiring the Subclass code Y "Not Elsewhere Classified (NEC)" for Industry Code 54-Vit/Min/Prot/Unconv Diet (Human/Animal) to improve data quality. Please use the relevant codes for Human Food Use products (A, B, C), Animal Use products (L, M, N, R), and Drug Use products (D, E, R, G) in place of Y. If your product falls under multiple Industry Code 54 Subclass codes (e.g., bulk product for further processing with intended use as both a human food product and an animal product) use the Subclass code that applies to the primary intended use of the product.
- For multi-ingredient products, use the product Class code of the ingredient first listed in the active ingredient portion of the product labeling/active ingredient list. Be sure you're looking at the active ingredient list. For dietary supplements, the active ingredients will be the Dietary Ingredients listed in the "Supplements Facts" section of the label. For drugs, this will be the "Active" ingredients list. Note: coding the first "Inactive" drug ingredient or the first dietary "Other Ingredient" would cause the product to be miscoded.
- For multi-ingredient animal use products, use the product Class code of the ingredient first listed in the active ingredient portion of the product labeling/active ingredient list for drug use products or the first ingredient for food products.
- Use the appropriate Subclass codes for multi-ingredients based on whether the product’s intended use is a human food (conventional food, dietary supplement), a human drug, or an animal use product.
- Products Process Indicator Codes (PIC) are used to describe the form of the product. For example, whether a vitamin is a tablet, capsule, or liquid.
Glossary
Vitamin: Any of various fat-soluble or water-soluble organic substances essential in minute amounts for normal growth and activity of the body.
Mineral: An inorganic element, such as calcium, iron, potassium, sodium, or zinc that is essential to the nutrition of human beings and animals.
Protein: Fundamental components of all living cells, includes many substances, such as enzymes, hormones, and antibodies, that are necessary for the proper functioning of an organism.
Dietary Supplement: A dietary supplement is any product for human use taken by mouth that contains one or more "dietary ingredients", is intended to supplement the diet, and is labeled as a dietary supplement. The "Dietary Ingredient" may be a vitamin, mineral, herbal or botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances [21 U.S.C. §321(ff)]. A dietary supplement can be found in many forms such as a tablet, capsule, softgel, gelcap, liquid, or powder [21 U.S.C. §350(c)(1)(B)]. For additional information, see Information for Industry on Dietary Supplements at FDA.gov.
Unconventional Dietary Specialty: This term refers to products for humans that are considered natural supplemental sources from plants and animals. Examples include: bee pollen, royal jelly, Echinacea, St. John's wort, borage oil, shark cartilage, fish oil, guar gum, and spirulina.
Drug: A product is considered to be a drug if the label or labeling contains claims that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or that it is other than a food that will affect the structure or function of the body [21 U.S.C. §321(g)].
Animal Use Products: Within Industry Code 54, "Animal Use Products" are foods or drugs intended for animals (other than humans) that are comprised of vitamins, minerals, proteins, herbal, or botanical ingredients to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Supplements for animals are regulated as either foods or drugs. Most animal foods should be coded under Industry Codes 69-72.
The Vitamin, Mineral, Protein and Unconventional Dietary Specialty Product Classes
| CLASS | NAME | PRODUCT EXAMPLES |
|---|---|---|
| A | Vitamin | Vitamin A, C, D, Niacin, Folic Acid, etc. |
| B | Mineral | Calcium, Copper, Iron, Potassium, Zinc, etc. |
| C | Protein | L-Aspartic Acid, L-Glutamine, L-Serine, etc. |
| E | Herbal & Botanical Teas I | Alfalfa, Echinacea, Ginko Biloba, St. John's Wort — code as "E" when used as teas |
| F | Herbal & Botanicals I (other than teas) | Alfalfa, Echinacea, Ginko Biloba, St. John's Wort — code as "F" when used as other than teas |
| G | Animal By-products and Extracts | Animal by-products and extracts from cows, sheep, pigs, sharks, etc. |
| H | Fats and Lipid Substances | Black currant oil, evening primrose oil, fish oil, Omega-3, etc. |
| I | Fiber | Guar Gum, Psyllium |
| J | Herbal & Botanical Teas II | Acai, Roselle |
| K | Herbal & Botanicals II (other than teas) | Acai, Roselle — code as "K" when used as other than teas |
| Y | Vitamin/Mineral/Protein and unconventional dietary specialty (N.E.C.) | Bee pollen, germanium, royal jelly, spirulina |
The Vitamin, Mineral, Protein and Unconventional Dietary Specialty Products Subclasses
The Subclass Codes for products under Industry Code 54 further describe the use of the product. You will need to know how the product is labeled or its intended use to determine if the product (vitamin, mineral, protein or unconventional dietary specialty) is a human food (conventional food or dietary supplement), a human drug, or an animal use product. If documentation is insufficient in determining the intended use of the product, verify/consult with the responsible party. In cases of bulk products intended for multiple applications (e.g., human food and animal use), select the Subclass code corresponding to the primary intended use. A vitamin, mineral, protein or dietary supplement is considered a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
For example, Vitamin K can be considered a dietary supplement or a drug. Labeled as a dietary supplement, you would use one of the Subclasses for Human Food Use (A, B, C). If the product is a fortified or enriched food (conventional food), you would use subclass A under Human Food Use (for more information on FDA’s food fortification guidance, see: Guidance for Industry, Questions and Answers on FDA’s Fortification Policy, Nov 2015). Labeled as a drug, you would use one of the Subclasses for Human Drug Use (D, E, F, or G). An example of a Vitamin K drug claim would be treatment of anticoagulant-induced deficiency of vitamin K-dependent clotting factors caused by coumarin (warfarin). If Vitamin K, which is approved as a prescription (Rx) drug, was the only active ingredient in the product (single ingredient), you would select the subclass F (Human Rx, single ingredient). Another example of a product that can be labeled as a dietary supplement or as a drug is folic acid, which would be considered a drug if there was a label claim such as treatment of megaloblastic anemias. Similar to the Vitamin K example, a Human Drug Use subclass would be selected for the folic acid.
| SUBCLASS | NAME | PRODUCT USE EXAMPLES |
|---|---|---|
| A | Human Food Enrichment (Further Processing) | Vitamin E; bulk form; intended for further manufacture into conventional foods and/or dietary supplements. |
| B | Human Food Dietary Supplementation — single ingredient | Vitamin E; finished product ready for consumption; no other dietary ingredients present. Use Subclass B for single ingredient Dietary Ingredients for use in Dietary Supplements, or single ingredient Dietary Supplements. |
| C | Human Food Dietary Supplementation — multi-ingredients | Vitamin E; finished product; ready for consumption; in combination with one or more dietary ingredients. Use Subclass C for multi-ingredient Dietary Ingredients for use in Dietary Supplements, or multi-ingredient Dietary Supplements. |
| SUBCLASS | NAME | PRODUCT USE EXAMPLES |
|---|---|---|
| D | Human Non-Rx Drug Use — single ingredient | For approved drugs, reference the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. For drugs under an OTC Monograph, reference OTC Monographs@FDA. |
| E | Human Non-Rx Drug Use — combination of ingredients | For approved drugs, reference the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. For drugs under an OTC Monograph, reference OTC Monographs@FDA. |
| F | Human Rx Drug — single ingredient | Cyanocobalamin (Vitamin B12) intended for injection with the drug claim "treatment of pernicious anemia." |
| G | Human Rx Drug Use — combination of ingredients | For approved drugs, reference the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. |
| I | Investigational Drug Use |
| SUBCLASS | NAME | PRODUCT USE EXAMPLES |
|---|---|---|
| L | Animal Food Nutritional Ingredient (Further Processing) | 25-hydroxyvitamin D3 food additive for further manufacturing into animal food or water for chickens, spices and seasonings (ginger, fenugreek seed, etc.) for further manufacturing into animal food, non-medicated vitamin & mineral pre-mixes. |
| M | Animal Food Supplement for Nutritional Use (Finished Form) | Calcium nutritional tablets for dogs, Lactobacillus acidophilus probiotic powder for dogs, fish oil for cats, vitamin C drops for guinea pigs, finished products (not for further manufacturing) and fed directly to the animal with or without food. |
| N | Animal Non-Rx Drug Use | Chondroitin and glucosamine soft chews for prevention or treatment of arthritis in dogs or to support joint health, silymarin (milk thistle) and s-adenosylmethionine (SAM-e) for liver support, cranberry for prevention of urinary tract infections in dogs and cats. For approved animal drugs, reference the Green Book, at https://animaldrugsatfda.fda.gov/adafda/views/#/search. |
| R | Animal Rx Drug Use | Selenium tocopherol emulsion for prevention and treatment of white muscle syndrome (selenium deficiency) in calves. For approved animal drugs, reference the Green Book, at https://animaldrugsatfda.fda.gov/adafda/views/#/search. |
The Vitamin, Mineral, Protein and Unconventional Dietary Specialty Products Process Indicator Codes (PIC)
The PIC is used to describe the form of the product. For example, whether a vitamin is a tablet, capsule or a liquid. This information should be available from the manufacturer. Below is a brief definition of the PIC codes currently in use.
| PROCESS INDICATOR CODE | NAME | PROCESS/FORM DEFINITION |
|---|---|---|
| A | Prompt Release Tablets | All prompt release tablets, coated or uncoated. Active ingredient immediately released (e.g., chewable tablets, orally disintegrating tablets). |
| B | Extended Release Tablets | All extended release tablets, coated or uncoated (active ingredient released over a prolonged period). |
| C | Delayed Release Tablets | All tablets with delayed release (not extended release, e.g., enteric coated tablets, active ingredient releases and is absorbed in the intestines). |
| E | Prompt Release Hard Gelatin Capsules | All hard gelatin capsules for prompt release. |
| F | Modified Release Hard Gelatin Capsules | All hard gelatin capsules having extended or delayed release. |
| H | Soft Gelatin Capsules | All soft gelatin capsules. |
| I | Vegan Capsules | All vegan capsules produced with material derived from plants. For gelatin capsules derived from animals – use PIC F & H. |
| J | Non-Sterile Ointments | Any of various substances resembling cream that have a healing effect when applied. An ointment has an oil base whereas a cream is water-soluble. Includes non-sterile ointment, cream, paste, dressing, poultice, gel, jelly. |
| K | Sterile Liquid | A sterile liquid is free from live bacteria or other microorganisms. |
| L | Non-sterile Liquid | Elixir, medicated shampoo, mouthwash, nasal spray solution, spirit, tincture, syrup suspension. |
| M | Suppositories | A small plug of medication designed to melt at body temperature within a body cavity other than the mouth, especially the rectum or vagina. |
| N | Large Volume Parenteral >=100 ml | Single dose solutions, 100 ml or greater. Parenteral means the product is taken into the body or administered in a manner other than through the digestive tract, such as by intravenous or intramuscular injection. |
| O | Sterile Ointment | Sterile ointments are free from live bacteria or other microorganisms. |
| P | Small Volume Parenteral <100ml | Less than 100 ml. Includes emulsion solutions, repository suspensions, dry solid, and sterile bulk powders for solution or suspension. |
| Q | Aerosol Dispersed Medication | Foam, powder, spray, nebulizers (excludes products packaged in non-metered mechanical dispensers – e.g., nasal sprays). |
| R | Non-sterile Powder | Effervescent for reconstitution (oral use) Topical (excludes aerosols and bulk pharmaceutical chemicals). |
| S | Bulk Pharmaceutical | |
| T | Dried – Natural or Artificial | Dried products may be dried naturally or using heat, cold, or chemicals. |
| U | Chewable Gel | All gummy or soft chewable products, including vegan gummies. |
| V | Compressed Medical Gas | Any gas for medicinal use. |
| W | Cultured or Cured | Cultured or Cured includes products that are cultured, fermented, salted, pickled, smoke cured, or sugar cured, as well as products that have undergone an enzymatic reaction. |
| X | Block or Bolus Premix | Premix, dry; Premix, liquid; mineral or salt mixture block.
Bolus: enteric coated: immediate action, sustained action. Bolus: uncoated or plain coated: immediate action, sustained action. Bolus is a large pill; used especially in veterinary medicine. |
| Y | NEC | Not Elsewhere Classified. |
| Z | Sterile Powder | Sterile powders (excludes those used for small volume parenterals). |
Check Your Knowledge
Code the Products
Now you will have a chance to practice coding some Vitamin, Mineral, Protein, and Unconventional Dietary Specialty Products. Below you will find five product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.
Have paper and a pen or pencil handy. As you code each product, write down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application, it will take you to the beginning of the Tutorial.
MULTIVITAMIN GEL CAPS (DIETARY SUPPLEMENT) containing the active ingredients: Vitamins A, D, & E
Vitamin, Mineral, Protein, Unconventional Dietary Supplement
Vitamin
Human Food Dietary Supplementation — Multi-Ingredients
Soft Gelatin Capsules
Vitamin A
(remember with multi-ingredient products choose first active ingredient)
ECHINACEA HERBAL DIETARY SUPPLEMENT 100CAP, 450 MG EA
Vitamin, Mineral, Protein, Unconventional Dietary Supplement
Herbal & Botanicals I (other than teas)
Human Food Dietary Supplementation — Single Ingredient
Soft Gelatin Capsules
Echinacea, Herbal & Botanicals (not tea)
HIBISCUS TEA (with a Supplement Facts label)
Vitamin, Mineral, Protein, Unconventional Dietary Supplementt
Herbal & Botanical Teas II
Human Food Dietary Supplementation—Single Ingredient
Dried — Natural or Artificial
Hibiscus Tea
VITAMIN E SOFT GEL CAPSULES, ANIMAL USE
Vitamin, Mineral, Protein, Unconventional Dietary Supplement
Vitamin
Animal Food Supplement for Nutritional Use (Finished Form)
Soft Gelatin Capsules
Vitamin E (Tocopherol)
Ergocalciferol (Vitamin D), 100 softgels, label claim: For the treatment of hypoparathyroidism and refractory rickets.
Vitamin, Mineral, Protein, Unconventional Dietary Supplement
Vitamin
Human Rx Drug — Single Ingredient
Soft Gelatin Capsules
Vitamin D
Check your answers — Click on reveal code for each product description to reveal the correct product code. Compare it with the one you got. Did you get the correct code? If not, determine which element was incorrect. You can go back to the product code builder application and try again.