PRX350 OTC Laws & Regulations

dietary supplement

include: vitamins, minerals, herbs or other botanicals 

used to supplement the diet by increasing intake

NOT FDA APPROVED for the treatment or prevention of health conditions 

examples: melatonin, probiotics 

over the counter (OTC) drug

drug that can claim to treat, cure, or prevent disease

can be used appropriately by consumers for self-diagnosed or minor conditions

FDA REGULATED PRODUCT that is determined safe and effective prior to approval

examples: medications for cough/cold, fever, heartburn, allergies

Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)

authorizes the FDA to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics

what is the purpose of the FDCA?

protect general public from adulterated or misbranded products in the United States

what act does the durham-humphrey amendment fall under?

federal food, drug, and cosmetic act of 1938 (FDCA)

durham-humphrey amendment

1951, defined over the counter medication and prescription only product categories

kefauver-harris amendement

1962, requires drugs to prove effectiveness and safety prior to market approval

nutrition labeling and education act

1990, requires FDA-regulated foods to have nutrition labeling and nutrient content listed

dietary supplement health and education act (DSHEA)

1994, allows FDA to regulate dietary supplement as food/nutrient rather than a drug

• DS only have to meet standards applied to food preparation

• DS do not require clinical trials to demonstrate efficacy and safety prior to being sold

• current good manufacturing practice (cGMP) requires that products do not have adulterants or impurities

• must be labeled accurately (potency, ingredients)

required elements of a supplement facts label

1. name of active ingredient(s) and the words “Dietary Supplement”

2. net quantity of contents 

3. manufacturer’s, packer’s or distributor’s name and place of business

4. directions for use

5. supplement facts label

6. “this statement has not been evaluated by the FDA. this product is not intended to diagnose, treat, cure or prevent disease 

required elements of an OTC drug

1. active ingredient- amount in each dosage unit

2. purpose of product- product of action or pharmacologic category

3. uses- symptoms or disease the product will treat or prevent

4. warnings- when not to use the product or require advice from HCP before taking product

5. dosage instructions

6. inactive ingredients

7. toll-free number to manufacturer

dietary supplement and nonprescription drug consumer protection act of 2006

requires manufacturers, packers, or distributors of dietary supplements to submit reports of serious adverse events received from the public

quality assurance programs for supplements 

USP dietary supplement verification program, ConsumerLab.com, NSF International

dietary supplement labels will indicate with seal of certification 

fraudulent or misleading claims associated with dietary supplements

1. mentions a specific disease state

2. states efficacy is similar to or can be used as an alternative to a medication

3. use of pseudo-medical terminology (ex. detoxifies, purifies)

4. hyperbolic language (ex. revolutionary therapy, breakthrough treatment)

5. promise of quick relief of a health condition

6. promotion of natural contact as being superior to conventional medicine

adulteration

a product that is defective, unsafe, or produced under insanitary conditions

• any substance substituted or mixed with ingredients to reduce quality or strength

misbranding

label is false or misleading

• fails to list name and place of business of the manufacturer, packer, or distributor

• does not contain accurate statement of quantity of contents