PCB Tutorial

Lesson 4 — Coding Food, Food-Related, Cosmetic and Vitamin Products

Vitamin, Mineral, Protein, and Unconventional Dietary Specialty products are covered under Industry Code 54. There is a unique set of Subclass codes for these products including different codes based on whether the product is for Food Use, Drug Use or Animal Use. The PIC codes are similar to those used for Antibiotics and Human Drugs and provide information concerning the dosage form of the product. There are additional PICS used in this Industry. They are Dried – Natural or Artificial (T) and Cultured or Cured (W).

  • Dietary supplements are limited to products taken orally (ingested/absorbed via the gastrointestinal tract) all other methods of administration (sublingual, intra-nasal, per rectal, injectable) are drugs.
  • Code multi-ingredient products under the product class 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. Sometimes a product label may list all ingredients before the active ingredients. For example, sterile water may be listed as the first ingredient but it is not an active ingredient. Using this ingredient would cause the product to be miscoded.
  • Use the appropriate subclass for multi-ingredients based on whether the product is considered a human food dietary supplement or a drug.
  • If the product contains a drug or antibiotics as well as dietary supplement ingredients they should be coded as a drug or antibiotic, not a dietary supplement.
  • Vitamin and mineral products that make medical claims may be considered to be drug products and should be coded as such. For example, label claims concerning diagnosis, cure, mitigation, treatment, or prevention of a disease cause a product to meet the definition of a drug product. See Lesson 5 Coding Drugs, Drug Products and Biologics.

Glossary

Vitamin: Any of various fat-soluble or water-soluble organic substances essential in minute amounts for normal growth and activity of the body and obtained naturally from plant and animal foods.

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 taken by mouth that contains a ‘dietary ingredient" and its label clearly states that it is a dietary supplement. The ‘dietary ingredient’ may be a vitamin, mineral, herbal or botanical, amino acid as well as substances such as enzymes, organ tissue, metabolites, extracts or concentrates. A dietary supplement can be found in many forms such as tablets, capsules, liquids, or powders.

Unconventional Dietary Specialty: This term refers to products for humans and animals that are considered natural supplement 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.

Rx: A prescription drug. Under Industry Code 54, this can be a vitamin, mineral, protein or unconventional dietary specialty.

Non-Rx: Under Industry Code 54, this refers to a vitamin, mineral, protein or unconventional dietary specialty that can be obtained without a prescription.

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 and Botanical Teas Alfalfa, Echinacea, Ginko Biloba, St. John's Wort  —  code as "E" when used as teas
F Herbal and Botanical (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 and Botanical II Acai, Roselle
K Herbal & Botanicals(other than teas) II Acai, Roselle code—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 Subclasses for products under Industry Code 54 further describes the use of the product. You will need to know how the product is labeled to determine if the product (vitamin, mineral, protein or dietary specialty) is a human food supplement, a human drug, or an animal use product. 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 E can be considered a food or a drug. Labeled as a dietary supplement, you would use one of the subclasses for Food Use or Animal Use (A, B, C, L, M). If the label states that it is used in the prevention of coronary heart disease, you would use one of the Drug or Animal subclasses (D, E, F, G, I, N, R). Another example is Iron. If it is used to prevent blindness in newborns it would be coded using a drug use subclass.

Note: Other human drugs not considered to be vitamins, minerals, proteins or dietary supplements are found under Industry Codes 60 – 66.

FOOD USES
SUBCLASS NAME PRODUCT USE EXAMPLES
A Enrichment for Human Foods (generally used by manufacturers Vitamin E; bulk form; intended for further manufacture into foods and/or dietary supplements.
B Human Food Dietary Supplementation  —  single ingredient Vitamin E; finished product ready for consumption; no other dietary ingredients present.
C Human Food Dietary Supplementation  —  multi ingredients Vitamin E; finished product; ready for consumption; in combination with one or more dietary ingredients.
DRUG USES
SUBCLASS NAME PRODUCT USE EXAMPLES
D Human Non-Rx Drug Use  —  single ingredient Vitamin E; finished product; ready for consumption claim with label ‘prevention of coronary heart disease"
E Human Non-Rx Drug Use  —  combination of ingredients Vitamin E and Omega-3; finished product; ready for consumption with label claim ‘prevention of coronary heart disease"
F Human Rx Drug  —  single ingredient Vitamin B12 intended for injection
G Human Rx Drug Use  —  combination of ingredients Vitamin B12 and B6 intended for injection
I Investigational Drug Use  
Y Not Elsewhere Classified (N.E.C.)  
ANIMAL USES
SUBCLASS NAME PRODUCT USE EXAMPLES
L Enrichment for Animal Feeds (generally used by feed manufacturers)  
M Animal Diet Supplementation  
N Animal Non-Rx Drug Use  
R Animal Rx Drug Use  
FOOD, DRUG, AND ANIMAL USES
SUBCLASS NAME PRODUCT USE EXAMPLES
Y Subclass, Not Elsewhere Classified (N.E.C.)  

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
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.
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.
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

1. Iron tablets would be coded under which of the following classes?
2. You are coding Vitamin E tablets. The label says the product "contributes to a healthy heart." Under suggested use, the manufacturer states: "As a dietary supplement, take one soft gel capsule daily, preferably with a meal." Which of the following subclasses would you choose for this product?
3. Which of the following Process Indicator Codes would you choose for a product labeled "Ginkgo Biloba Extract — 60 mg, Size: 60 soft cap"

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 notepaper 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 and Botanicals (other than tea)

Human Food Dietary Supplementation  —  Single Ingredient

Soft Gelatin Capsules

Echinacea, Herbal & Botanicals (not tea)

GINSENG TEA

Vitamin, Mineral, Protein, Unconventional Dietary Supplement

Herbal and Botanical Teas

Human Food Dietary Supplementation

Dried — Natural or Artificial

Ginseng (Herbal and Botanical Teas)

VITAMIN E SOFT GEL CAPSULES, ANIMAL USE

Vitamin, Mineral, Protein, Unconventional Dietary Supplement

Vitamin

Animal Dietary Supplementation

Soft Gelatin Capsules

Vitamin E (Tocopherol)

EVENING PRIMROSE OIL, 90 softgels, label claim: May prevent Fibrocystic Breast Disease (FBD) if taken regularly.

Vitamin, Mineral, Protein, Unconventional Dietary Supplement

Fats and Lipid Substances

Human Non Prescription,  —  Single Ingredient

Non-Sterile Liquid

Evening Primrose Oil (Fats and Lipid Substances)

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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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