Defining Drugs, Foods, Dietary Supplements, Devices and Cosmetics Part 1

Little

The fact that a supplier, even in good faith, does not believe that its product is a drug or does not want its product to be a drug has ____ relevance

Cosmetics; Drug

The legal distinction between cosmetics and drugs can be somewhat murky. For example, some cosmetics, such as fluoridated toothpaste, medicated mouthwash, or anti-dandruff shampoos are on the borderline between being classified as ____ or as ____ (non-prescription) products.

Not

The mere use of an article for therapeutic purposes by purchasers, where the supplier does not intend the product to be used therapeutically or makes no therapeutic claims, does ____ usually make the product a drug

Medical Foods

These are examples of what type of food?? Renal products for acute or chronic kidney failure, phenylalanine-free products for phenylketonuria, oral rehydration products, liquid very-lower calorie diets for weight loss

Foods; Food

According to the FDA, ____ and ____ products are broken down into the following categories: 1. Conventional Foods 2. Foods for Special Dietary Uses 3. Medical Foods 4. Dietary Supplements

1. Conventional Foods 2. Foods for Special Dietary Uses 3. Medical Foods 4. Dietary Supplements

According to the FDA, foods and food products are broken down into the following categories: (4)

Cosmetics

Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, shampoos, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Dietary Supplements; FDA's; Dietary Supplements

After intense lobbying by the dietary supplement industry (now $20+B/yr), Congress reacted by passing the Dietary Supplement Health and Education Act of 1994 ("DSHEA") further amending the FDCA by legally creating the category of ____ ____ and significantly altering the ____ authority to regulate the safety and labeling of ____ ____

Dietary Supplement Health and Education Act of 1994 ("DSHEA")

After intense lobbying by the dietary supplement industry (now $20+B/yr), Congress reacted by passing the ____ further amending the FDCA by legally creating the category of dietary supplements and significantly altering the FDA's authority to regulate the safety and labeling of dietary supplements.

Therapeutic; Health; B

Almost any food might be considered a drug if a ____ or ____ claim is made (e.g., Cheerios) for it under the part ____ of the drug definition (i.e., that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease).

Record; Investigate; Forward

Also unlike drug products, manufacturers and distributors of dietary supplements were NOT INITIALLY required by law to ____, ____ or ____ to FDA any reports they received of injuries or illnesses that may be related to the use of their products.

No (Exempt from NLEA; New regulations have been proposed but not finalized)

Are Medical foods subject to NLEA (Nutritional Labeling Education Act)??

Yes

Are regular foods subject to NLEA (Nutritional Labeling Education Act)??

Yes

Are special dietary foods subject to NLEA (Nutritional Labeling Education Act)??

NO!

Are special dietary foods used under medical supervision??

NO!

Can they make health claims (as medical foods) for special dietary foods)??

Dietary Supplement

Congress defined the term "____ ____" in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Body

Cosmetics are defined by their intended use, as (i) "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human ____... for cleansing, beautifying, promoting attractiveness, or altering the appearance".

Tested; Safety

Cosmetics do not need to be ____ for ____ like drugs do, but a cosmetic that poses a safety risk to the public could be considered to be misbranded

Misbranded

Cosmetics do not need to be tested for safety like drugs do, but a cosmetic that poses a safety risk to the public could be considered to be ____

Claims

Cosmetics vs. Drugs: The overriding factor in determining a product's status might not be its ingredients, but rather the manufacturer's ____, particularly on the label.

Diagnose; Cure; Treat; Prevent; Structure; Function

DRUG: In other words, was the article intended by the supplier to ____, ____, mitigate, ____, or ____ a disease, or (for articles other than food) was it intended to affect the body ____ or ____?

4; Nutritional Support

DSHEA allows dietary supplement suppliers to make ____ types of ____ ____ statements without fear that the statements would cause the FDA to consider the product to be a drug.

Well-being

DSHEA allows dietary supplement suppliers to make four types of nutritional support statements without fear that the statements would cause the FDA to consider the product to be a drug: 4. Statements describing the general ____ from consumption of a nutrient or dietary ingredient (e.g., "energizer," "relaxant," "muscle enhancement")

Benefit; Nutrient Deficiency

DSHEA allows dietary supplement suppliers to make four types of nutritional support statements without fear that the statements would cause the FDA to consider the product to be a drug: 1. Statements that the product will ____ a classical ____ ____ disease as long as it also discloses the prevalence of the disease in the United States

Structure; Function

DSHEA allows dietary supplement suppliers to make four types of nutritional support statements without fear that the statements would cause the FDA to consider the product to be a drug: 2. Statements that describe the role of the dietary supplement in affecting the ____ or ____ of the body such as, "folic acid may reduce the risk of neural tube birth defects" and "calcium may reduce the risk of osteoporosis."

Mechanism; Structure; Function

DSHEA allows dietary supplement suppliers to make four types of nutritional support statements without fear that the statements would cause the FDA to consider the product to be a drug: 3. Statements that characterize the documented ____ by which a nutrient or dietary supplement acts to maintain ____ or ____

Controversial

DSHEA has proved thus far to be an extremely ____ law

Foods; Dietary Supplement

DSHEA places dietary supplements in a special category under the general umbrella of "____," not drugs, and requires that every supplement be labeled a ____ ____

Premarket Approval; Unsafe

DSHEA stripped the FDA of ____ authority. Under DSHEA the FDA must prove that a dietary supplement is ____ before it can restrict or remove the product from the market

Drug; B; Drug

DSHEA thus exempts dietary supplements from part C of the FDCA drug definition by permitting structure/ function claims. For example, a manufacturer could promote that its cranberry tablets increase the acidity of the urine and help to maintain a healthy urinary tract. (i.e., mechanism by which a nutrient or dietary supplement acts to maintain structure or function) But, if the manufacturer made the claim that its cranberry tablet product prevents or treats urinary tract infections, this assertion could make the product a ____ under part ____ of the ____ definition (i.e., intended to diagnose, cure, mitigate, treat, or prevent a disease).

Not; Healthy

DSHEA thus exempts dietary supplements from part C of the FDCA drug definition by permitting structure/ function claims. Similarly, a manufacturer could ____ claim a product, like yogurt with probiotics, helps prevent or treat diarrhea associated with antibiotic use (therapeutic claim), but could state that it "helps maintain ____ intestinal flora."

C; Structure/ Function

DSHEA thus exempts dietary supplements from part ____ of the FDCA drug definition by permitting ____/ ____ claims

Yes

Do medical foods require a physician's direction??

No

Do regular foods have any medical directions/ special requirements??

No

Do special dietary foods require a physician's direction??

Supplier's; Purchaser's

Drug: It is the ____ intended use of the product that is important, not the ____ intended use

Food

Essentially, DSHEA mandates that the FDA regulate dietary supplements more as a special type of ____ than as drugs. This shifts the burden of proof significantly.

DSHEA

Essentially, ____ mandates that the FDA regulate dietary supplements more as a special type of food than as drugs. This shifts the burden of proof significantly.

Medical Foods

Examples of ____ ____ include foods formulated without the amino acid phenylalanine for phenylketonuria, and folic acid, B6, B12 combination products for hyperhomocysteinemia.

Phenylalanine; Phenylketonuria; Folic Acid; B6; B12

Examples of medical foods include foods formulated without the amino acid ____ for ____, and ____, ____, ____ combination products for hyperhomocysteinemia.

Special Dietary Foods

Examples of products in this category include infant formulas, artificial sweeteners, and caloric supplements, hypoallergenic foods. Reduced CHO or sugar‐free products for diabetics, lactose‐free products for lactose intolerance, meal replacements for weight loss.

Advertising; Dietary Supplements

FTC, not FDA, regulates ____ and therefore monitors for misleading claims for ____ ____

C; Foods

Food Vs. Drugs: BUT, Part ____ of the drug definition, specifically excludes ____ (i.e., "articles [other than food] intended to affect the structure or any function of the body of man or other animals."

Regular Food

Food safe and suitable for human consumptions

Medical Food

Foods formulated to aid in the dietary management of a specific disease or health-related condition that causes distinct nutritional requirements different from the nutritional requirements of healthy individuals

Special Dietary Foods

Foods that are specially formulated to meet a special dietary need, such as food allergy, difficulty in swallowing, or weight loss. They provide nutritional requirements

Manufacturer; Packer; Distributor

However, as of December 2007, the DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT amended the FDCA and the ____, ____, or ____ whose name appears on the label of a dietary supplement marketed in the United States is now required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States within 15 days via the MEDWATCH Program

Adverse; 15; MEDWATCH

However, as of December 2007, the DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT amended the FDCA and the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is now required to submit to FDA all serious ____ event reports associated with use of the dietary supplement in the United States within ____ days via the ____ Program

DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT

However, as of December 2007, the ____ amended the FDCA and the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is now required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States within 15 days via the MEDWATCH Program

Physician; Disease; Condition; Requirements

Medical foods include foods formulated for oral/enteral use under the supervision of a ____ and that are intended for the specific dietary management of a ____ or ____ for which distinctive nutritional ____ are established by medical evaluation

Health Claims; Structure/ Function Claims; Nutrient Content Claims

Nutritional Support (Structure/ Function) Statements DSHEA allows manufacturers to make three types of claims for their dietary supplement products: What are the 3 types??

Increase; Opposite

Passage of DSHEA was controversial. 1980-early '90s Congress was trying to ____ powers of FDA to regulate dietary supplements. DSHEA accomplished the ____ result

Federal Trade Commission (FTC)

Regulation of advertising and labeling of cosmetics basically falls under the jurisdiction of the ____

Foods; Drugs; Cosmetics

Section 201 of the Food Drug and Cosmetic Act (21 U.S.C. § 321) defines ____, ____, and ____. Understanding these definitions is critical to understanding the FDCA.

FDCA; FDCA (Food Drug and Cosmetic Act)

Section 201 of the ____ (21 U.S.C. § 321) defines Foods, Drugs, and Cosmetics. Understanding these definitions is critical to understanding the ____

Need; Physical; Physiological; Pathological; Condition

Special Dietary Foods under the FDCA, include those supplying a special dietary ____ that exists because of a ____, ____, ____, or other ____, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium

Infant; Sweeteners; Supplements; Hypoallergenic

Special Dietary Foods: Examples of products in this category include ____ formulas, artificial ____, and caloric ____, ____ foods. Reduced CHO or sugar‐free products for diabetics, lactose‐free products for lactose intolerance, meal replacements for weight loss.

Natural; Dietary; Health

The distinction between foods and drugs has become an important issue, especially in view of the proliferation and popularity of ____ products, ____ supplements, and other "____ food" type products.

Dietary Supplements

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 amendment to the FDCA which defines and regulates ____ ____

Foods

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 amendment to the FDCA which defines and regulates dietary supplements. Before this time, dietary supplements were subject to the same regulatory requirements as ____

Premarket Approval

The FDA cannot require ____ ____ of dietary supplements as they do for drugs

Dietary Supplements

The FDA cannot require premarket approval of ____ ____ as they do for drugs

Special Dietary Foods; Medical Foods

The FDCA has created at least two special categories of foods, including "____" and "____"

Drugs; Therapeutic

The FDCA has created at least two special categories of foods, including "special dietary foods" and "medical foods." Without this legal recognition, the FDA would likely regard articles falling into these 2 special categories as ____ since they really come close to promoting ____ claims, i.e. since they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Dietary Supplement Health and Education Act of 1994 ("DSHEA")

The ____, is a 1994 amendment to the FDCA which defines and regulates dietary supplements.

Drug

The crucial issue in the determination of whether a product is a ____ centers on whether the supplier made a therapeutic or health claim, or a structure/ function claim.

Therapeutic; Health; Structure; Function

The crucial issue in the determination of whether a product is a drug centers on whether the supplier made a ____ or ____ claim, or a ____/ ____ claim.

Dietary Supplement

The definition of ____ ____ includes, sports performance products, protein powders, weight loss products, vitamins, minerals, and most herbal remedies

Sports; Protein; Loss; Vitamins; Minerals; Herbal

The definition of dietary supplement includes, ____ performance products, ____ powders, weight ____ products, ____, ____, and most ____ remedies

Regular Food

These are examples of what type of food?? Regularly processed foods

Food

The term "____" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article

Drug

The term "____" means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).

Diagnosis; Cure; Treatment; Prevention

The term "drug" means (B) articles intended for use in the ____, ____, mitigation, ____, or ____ of disease in man or other animals; and

Structure; Function

The term "drug" means (C) articles (other than food) intended to affect the ____ or any ____ of the body of man or other animals; and

Component

The term "drug" means (D) articles intended for use as a ____ of any articles specified in clause (A), (B), or (C).

US Pharmacopeia; Homeopathic Pharmacopoeia of the US; National Formulary

The term "drug" means (A) articles recognized in the official ____, official ____, or official ____, or any supplement to any of them; and

Food; Drink; Gum; Components

The term "food" means (1) articles used for ____ or ____ for man or other animals, (2) chewing ____, and (3) articles used for ____ of any such article

Special Dietary Foods

These are examples of what type of food?? Reduced CHO or sugar-free products for diabetics, lactose-free products for lactose intolerance, meal replacements for weight loss

Not Really

This then raises the question: Was it really the intent of Congress when it created the FDCA to exclude all substances normally defined as foods from the definition of a drug, regardless of their intended use, from the definition of Drugs?

Truthful; Misleading; FDA; Diagnose; Treat; Cure; Prevent

To make any of these four nutritional support statements, the manufacturer must have substantiation that they are ____ and NOT ____, and the label of the product must contain the disclaimer, "This statement has not been evaluated by the ____. This product is not intended to ____, ____, ____, or ____ any disease." (21 C.F.R. part 101)

Dietary Supplement

Under DSHEA, a ____ ____ is defined as a product (other than tobacco) that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: • - A vitamin - A mineral - An herb or other botanical - An amino acid - A dietary substance for use by humans to supplement the diet by increasing the total dietary intake - A concentrate, metabolite, constituent, extract, or combination of the previous ( 21 U.S.C. § 321( ff))

Vitamin; Mineral; Herb; Amino Acid; Supplement; Concentrate

Under DSHEA, a dietary supplement is defined as a product (other than tobacco) that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: • - A ____ - A ____ - An ____ or other botanical - An ____ - A dietary substance for use by humans to ____ the diet by increasing the total dietary intake - A ____, metabolite, constituent, extract, or combination of the previous ( 21 U.S.C. § 321( ff))

Safe; Evidence

Under DSHEA,the Manufacturer - not the FDA - is responsible for determining that the dietary supplements it manufactures or distributes are ____ and that any representations or claims made about them are substantiated by adequate ____ to show that they are not false or misleading.

Manufacturer; FDA

Under DSHEA,the ____ - NOT the ____ - is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.

Food; Drug

Unless an exception applies (e.g. it's a ____), if therapeutic or structure/ function claims are made, an article is a ____, no matter what disclaimers may be included in the labeling.

Therapeutic; Structure; Function

Unless an exception applies (e.g. it's a food), if therapeutic or structure/ function claims are made, an article is a drug, no matter what disclaimers may be included in the labeling. Thus, a supplier cannot mitigate a ____ or ____/ ____ claim for a product by proclaiming that the product is not a drug.

Adulterated

Unlike Drugs, Cosmetic manufacturers do not need to meet FDA Good Manufacturing Practices (CGMP), but they still must be manufactured under sanitary conditions, otherwise they might be determined by the FDA to be ____

FDA Good Manufacturing Practices (CGMP); Sanitary

Unlike Drugs, Cosmetic manufacturers do not need to meet ____, but they still must be manufactured under ____ conditions, otherwise they might be determined by the FDA to be adulterated.

Pre-marketing Approval

Unlike Drugs, cosmetics do not require ____ ____ from the FDA, with the important exception of color additives

Color Additives

Unlike Drugs, cosmetics do not require premarketing approval from the FDA, with the important EXCEPTION of ____ ____

FDA; Safety; Effectiveness

Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for ____ to "approve" dietary supplements for ____ or ____ before they reach the consumer.

Special Dietary

____ ____ Foods under the FDCA, include those supplying a special dietary need that exists because of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium

Nutrient Content Claims

____ ____ ____: The amount of a nutrient or dietary substance in a product.

Medical Foods

____ ____ include foods formulated for oral/enteral use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation

Structure/ Function Claims

____ ____: The intended benefits of using the product; and,

Health Claims

____ ____: the link between a food substance and disease or a health-related condition;

Cosmetics

____ are defined by their intended use, as (i) "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance".

FTC; FDA

____, NOT the ____, regulates advertising and therefore monitors for misleading claims for DIETARY SUPPLEMENTS