Federal Laws that Govern Food, Supplements, and Cosmetics

By Jesse Langel, Esq., LL.M.

| April 04, 2023

Here are some key federal laws regulating food, beverages, dietary supplements, and cosmetics in the United States. Under each section are lists of the 10 most common products regulated under each law.

Federal Food, Drug, and Cosmetic Act (FDCA)

This law establishes the FDA's authority to oversee the safety of food, drugs, and cosmetics sold in the United States. It requires that food and drugs be safe for human consumption and that cosmetics not be adulterated or misbranded.

The FDCA regulates a wide range of products, but here are 10 of the most common products that fall under its purview:

Food, including both human and animal food products
Drugs, including prescription and over-the-counter medications
Medical devices, including everything from tongue depressors to pacemakers
Cosmetics, including makeup, skin creams, and hair products
Electronic nicotine delivery systems (ENDS), including e-cigarettes and vape pens
Dietary supplements, including vitamins, minerals, and herbal products
Infant formula and baby food
Food additives and colorings
Animal drugs and feed
Biologics, including vaccines, blood, and blood products, and gene therapies

Food Safety Modernization Act (FSMA)

This law, enacted in 2011, aims to improve food safety by shifting the focus from responding to foodborne illness outbreaks to preventing them from occurring in the first place. It requires food facilities to implement preventive controls to minimize contamination risk and develop food safety plans.

Here are 10 of the top products regulated by the FSMA:

Fresh produce, including fruits and vegetables
Dairy products, such as milk and cheese
Seafood and shellfish, including raw oysters and other mollusks
Eggs and egg products
Ready-to-eat foods, including deli meats and salads
Sprouts and sprout seeds
Pet food and animal feed
Processed foods, including canned goods and baked goods
Grains and cereals, including rice and wheat
Spices and seasonings

Nutrition Labeling and Education Act (NLEA)

This law requires most packaged food products to bear a nutrition label that provides information about the product's nutritional content, including the number of calories, fat, protein, and other nutrients.

Here are 10 of the top products regulated by the Nutrition Labeling and Education Act (NLEA), including dietary supplements:

Breakfast cereals
Bread and baked goods
Snack foods, including chips, crackers, and popcorn
Soups and broths
Canned and bottled beverages, including soda, juice, and sports drinks
Frozen foods, including entrees and vegetables
Candy and sweets
Dairy products, including milk, yogurt, and cheese
Meat and poultry products, including ground beef and chicken
Dietary supplements, including vitamins, minerals, herbals, and other botanicals

Dietary Supplement Health and Education Act (DSHEA)

This law defines dietary supplements as a separate food category and sets forth requirements for their labeling and advertising. It also allows specific health claims about supplements, subject to certain conditions.

Here are 10 of the top products regulated by the DSHEA:

Vitamins, including vitamin C, vitamin D, and multivitamins
Minerals, including calcium, iron, and magnesium
Herbal supplements, including echinacea, ginseng, and St. John's Wort
Probiotics and prebiotics
Sports nutrition supplements, including protein powders and creatine
Weight loss supplements, including green tea extract and garcinia cambogia
Omega-3 supplements, including fish oil and krill oil
Joint health supplements, including glucosamine and chondroitin
Coenzyme Q10 (CoQ10)
Fiber supplements, including psyllium and inulin

Fair Packaging and Labeling Act (FPLA)

This law requires that consumer commodities, including food, beverages, and cosmetics, be labeled with accurate and informative information about the contents and the identity of the product.

Here are 10 of the top products regulated by the FPLA:

Food products, including packaged meats, snacks, and beverages
Cosmetics, including makeup, skin care products, and hair products
Household cleaning products, including laundry detergent and dish soap
Personal care products, including soap and shampoo
Over-the-counter drugs, including pain relievers and cough medicines
Toys and games
Clothing and textiles
Appliances and electronics
Pet food and animal feed
Automotive products, including motor oil and antifreeze

Food Allergen Labeling and Consumer Protection Act (FALCPA)

This law requires that food labels identify any of the eight major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) in the product.

Here are 10 of the top products regulated by the FALCPA:

Milk and dairy products
Eggs and egg products
Fish and shellfish, including crab, lobster, and shrimp
Wheat and wheat products, including bread and pasta
Soybeans and soy products
Peanuts and peanut products
Tree nuts, including almonds, walnuts, and pecans
Sesame seeds and sesame products
Sulfites used as a preservative in many foods and beverages
Mustard and mustard products

Federal Trade Commission Act (FTC Act)

This law gives the Federal Trade Commission (FTC) authority to regulate advertising and marketing practices for food, beverages, dietary supplements, and cosmetics. It prohibits deceptive or unfair advertising practices and gives the FTC the power to take action against companies that engage in such practices.

Here are 10 of the top products and services regulated by the FTC Act:

Dietary supplements, including weight loss supplements and health-related claims
Consumer electronics, including smartphones, laptops, and gaming consoles
Automobiles and other motor vehicles, including safety claims and fuel efficiency claims
Credit and loan services, including debt consolidation and credit repair
Home appliances, including washing machines, refrigerators, and air conditioners
Insurance products, including life insurance and health insurance
Travel and hospitality services, including hotel bookings and vacation packages
Online education and training programs, including claims about job placement and earning potential
Cosmetics and personal care products, including claims about anti-aging and beauty benefits
Food and beverage products, including health and nutrition claims and ingredient labeling

Food and Drug Administration Amendments Act (FDAAA)

This law established requirements for the registration and reporting of clinical trials for drugs, biologics, and medical devices and requires the registration of clinical trials for specific dietary supplements. It also requires the FDA to post information about clinical trials on its website.

Here are 10 of the top products regulated by the FDAAA:

Prescription drugs and biologics, including new drugs seeking FDA approval
Medical devices, including new devices seeking FDA approval
Clinical trials for drugs, biologics, and medical devices, including registration and reporting requirements
Pediatric drugs and devices, including incentives for conducting pediatric studies
Postmarket studies and clinical trials, including requirements for conducting and reporting on these studies
Risk evaluation and mitigation strategies (REMS), including requirements for developing and implementing these programs for certain drugs and biologics
Direct-to-consumer advertising of prescription drugs, including requirements for submitting ads to the FDA for review
Drug importation and reimportation, including requirements for ensuring the safety of imported drugs
Pharmacy compounding, including new requirements for compounding pharmacies
Biosimilars, including requirements for the FDA to develop and implement a regulatory pathway to approve biosimilars.

Public Health Service Act (PHSA)

This law authorizes the Department of Health and Human Services to regulate the safety of biological products, including vaccines and blood products. It also sets forth requirements for the safety and efficacy of medical devices.

Here are 10 of the top products regulated by the PHSA:

Vaccines for infectious diseases, including measles, mumps, rubella, and hepatitis B
Blood products, including whole blood, platelets, and plasma
Biologics, including insulin and growth hormone
Medical devices, including implantable devices, diagnostic equipment, and surgical instruments
Gene therapies, including treatments for rare genetic disorders
Antibiotics and antivirals, including treatments for tuberculosis and HIV
Hormonal treatments, including estrogen replacement therapy and testosterone replacement therapy
Cancer treatments, including chemotherapy drugs and radiation therapy devices
Cardiovascular treatments, including pacemakers and stents
Neurological treatments, including drugs for multiple sclerosis and Parkinson's disease

New York Law: Misbranding of food products

New York Agriculture and Markets Law, Article 17—Adulteration, Packing, and Branding of Food and Food Products: This law regulates the labeling, advertising, and selling food products in New York. It prohibits the misbranding of food products and requires that all food products sold in New York be appropriately labeled with accurate and truthful information.
New York General Business Law, Article 22-A—Consumer Protection from Deceptive Acts and Practices: This law regulates deceptive and misleading business practices, including false or misleading labeling of food products. It prohibits using false or misleading representations in labeling, advertising, or selling food products.

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