FSHN 403-Exam 3
Recognize various criteria that the FDA uses to distinguish dietary supplements and drugs
"Dietary ingredient" may contain: Vitamins, minerals, herbs or other botanicals, amino acids, other substances found in the human diet, such as enzymes Drug - FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" Dietary supplement can be regulated as a drug if it meets drug definition
Recognize the role that FDA's Office for Regulatory Affairs plays within the organization
"FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities" "Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited" "The use of the word "should" in Agency guidance means that something is suggested or recommended, but not required"
Federal Safety Reporting Portal - what is this and who uses it?
"The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH). Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all."
Be familiar with Regulations.gov - what is it? How is it used?
"Your Voice In Federal Decision-Making", is one way that stakeholders - which could include individual citizens, industry groups, companies, consumer protection groups, other agencies, etc. - are able to put in their "two cents" and potentially influence the regulatory process."
Recognize synonyms of cell-cultured food products
"test tube meat", "cultured meat", "clean meat"
Recognize the full scope of descriptors for what a "dietary ingredient" is
- a "dietary ingredient" is: a vitamin a mineral an herb or other botanical an amino acid a dietary substance for use by man to supplement the diet by increasing total dietary intake or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients
What are some of the questions that must be answered about cell-based meats before appropriate rules can be developed for their regulation?
-Amino acid composition? Is it a complete protein like animal-sourced meats (adequate amounts of the 9 essential AA's)? -Does it have the same functional characteristics as animal meat? -How will it perform in a product? -Are cultured meats metabolized in the same way by humans as animal-sourced meats? -What about safety? "We just don't know enough about the products - the shelf life and any risks that might be in place"
Recognize the importance of DEFINITION and INTENT in differentiating between Drugs and Dietary Supplements
-Remember the importance of definitions at the beginning of any piece of legislation -These help consumers and industry understand how the law applies to them Definitions also help guide rule-making and regulatory enforcement
Beyond dietary supplements, be able to recognize two other classes of foods that have been subject to amendments of the law or additional layers of regulation due to their inherent risks
-liquid dietary supplements like energy drinks -Dietary supplement or drug?
Recognize the conditions under the 1906 Act where fortified foods might have been subject to legal action under the law's drug provisions
-products on the market claiming fortification or the presence of nutrients that were purported to act against disease - but dietary supplements were not yet a distinct category -products whose packaging contained enough claims to qualify as a drug had legal actions pursued under the drug provisions
Familiarize yourself with the proposed Amazon SNAP online trial story
Amazon and Walmart will participate in the initial pilot launch today with ShopRite joining early next week. ShopRite and Amazon are providing service to the New York City area and Walmart is providing online service in upstate New York locations. Additional retailers are slated to participate in the pilot in coming months. The pilot will eventually expand to other areas of New York as well as Alabama, Iowa, Maryland, Nebraska, New Jersey, Oregon and Washington. The pilot will test both online ordering and payment. SNAP participants will be able to use their benefits to purchase eligible food items, but will not be able to use SNAP benefits to pay for service or delivery charges. For more information, please visit the SNAP Online Purchasing pilot webpage.
Recognize the definition of a New Dietary Ingredient (NDI)
Any dietary ingredient that was not marketed in the United States before October 15th, 1994 Companies must be sure that the substance is considered to be a "dietary ingredient" - defined per law as: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.
What is at Citizens Petition? What is the origin/basis of the concept? What are the components in such a petition? What are some limitations or hurdles for use of this approach for ordinary citizens?
As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."" The Citizen Petition process is described in 21 CFR 10.30 (Links to an external site.)Links to an external site.. The basic format includes: Action Requested of the FDA Commissioner (issue, amend or revoke an order?) A Statement of Grounds (full statement, in a well-organized format, of the factual and legal grounds on which the petitioner is basing the petition) Environmental Impact Economic Impact Certification (statement indicating that to the best knowledge and belief of the petitioner, the petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition)
Recognize an early example of a dietary supplement in the US
Cod liver oil (good source of vitamins A and D) is often considered the first example of a dietary supplement in the U.S.
Understand the process that companies who wish to market dietary supplements containing NDI's need to undertake
Company must notify FDA. The notification must include why the manufacturer or distributor has concluded that a dietary supplement containing an NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling
what the abbreviation "DSHEA" stands for
Dietary Supplement Health and Education Act
Recognize the role that the mode of delivery plays in defining a substance as a dietary supplements
Dietary supplements are only those products which are consumed orally. Any product claiming dietary supplement status which is topical, injectable or inhalable is NOT a dietary supplement - these meet the definition of drugs and are regulated as drugs.
description of a dietary supplement
Dietary supplements are only those products which are consumed orally. Any product claiming dietary supplement status which is topical, injectable or inhalable is NOT a dietary supplement - these meet the definition of drugs and are regulated as drugs. A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains one or more "dietary ingredients." The "dietary ingredients" in these products may include Vitamins, minerals, herbs or other botanicals, amino acids, other substances found in the human diet, such as enzymes
Recognize potential conflicts of interest for federal agencies that are tasked both with using unbiased, science-based information for setting nutrition policy AND with supporting sectors of our agricultural economy that may conflict with such policies
Does the USDA have any conflicts of interest between their goals of: Supporting the American Agricultural economy Ensuring that nutrition advice is science-based and optimized for best human health outcomes
As the dietary supplement market segment grew over the years, recognize the general state of enforcement surrounding dietary supplements that persisted for many years
FDA attempted industry self-regulation in 1962, but proposed to regulate "high potency" supplements as drugs, which didn't sit well with industry, leading to abandoning of the proposed rule Congress began an intervention into dietary supplement regulation in 1976 - with the Vitamin Mineral Amendment of 1976 - but this was not very broad in scope The Nutritional Labeling and Education Act (NELA) of 1990 established nutrient content and claims for food products and required labels to declare any vitamin or mineral supplementation
Understand the implications of FDA failing to respond to a company's NDI notification within 75 days - does this indicated that the agency finds the NDI to be safe and the product not adulterate?
Failure of FDA to respond to a notification does not indicate that FDA finds it safe or not adulterated
Understand what a fortified food is and recognizes examples
Fortified foods have isolated nutrients added - with the intention of supplementing the diet by providing nutrients that might be missing due to a poor diet EX) Cows Milk (Vitamin A & D added); Pasta (folic acid added); Orange Juice (Calcium added); Salt (iodine added)
Recognize statements about DSHEA regarding the law's intent
It's primary limitation is not in what a dietary supplement may contain, but on it's application Dietary supplements are only those products which are consumed orally. Any product claiming dietary supplement status which is topical, injectable or inhalable is NOT a dietary supplement. The term "dietary ingredient" also broadly encompasses functional ingredients that supplement the diet, but excludes added substances like fillers, preservatives or emulsifiers.
Recognize elements of the NDI notification process
Must notify the FDA: -Must include: why manufacturer or distributor has concluded a NDI will reasonably be expected to be safe under recommend labeling
Recognize a successful Citizens Petition (Dr. Fred Kummerow, partially hydrogenated oil ban)
One Citizen Petitioner, Dr. Fred Kummerow, then-98-year old Professor Emeritus at the University of Illinois filed a petition with FDA in 2009 to ban partially hydrogenated oils. In 2013, tired of waiting for the FDA to respond, Dr. Kummerow filed a lawsuit (Links to an external site.)The FDA's failure to respond to his petition violated both the Administrative Procedures Act and the Food, Drug, and Cosmetic Act. The lawsuit compelled the FDA to respond to Dr. Kummerow's Citizen Petition, which ultimately resulted in the FDA determining that partially hydrogenated oils were not Generally Recognized as SAFE (GRAS) (Links to an external site.)
As a consumer, how can you use labeling to recognize the difference between a conventional food and a dietary supplement
One way to distinguish dietary supplements from conventional foods is by looking at the nutrition information on the label of the product. Conventional foods must have a "Nutrition Facts" panel on their labels, but dietary supplements must have a "Supplement Facts" panel
Multistate Outbreak of Salmonella Linked to the Dietary Supplement Kratom - FDA First Instance of Mandatory Product Recall - be familiar with specifics of this posting
Ongoing multistate outbreak of Salmonella linked to dietary supplements containing Kratom, an herb belonging to the coffee family Kratom was already on FDA's radar, as it has some similarities (in computer-based binding studies) to opioids - could be treated as an unapproved drug Triangle Pharmanaturals, Las Vegas, responsible for distribution of Salmonella-associated kratom - they did not cooperate with FDA
Recognize new authorities conferred on the FDA under the 1938 Act regarding dietary supplements
Passage of the 1938 Act changed regulation of dietary supplements in several ways Including providing authority to FDA to regulate the labeling of food for "special dietary uses" - which still remains in effect today The 1938 Act also expanded the FDA's authority to include "labeling" and not just the "label" Based on Kordel vs. the United States, where a company mailed drugs and a pamphlet separately, the FDA today interprets "labeling" to include "brochures, booklets, video, sound, images, websites, social media and metadata" Under the1938 Act, the FDA also gained the ability to enforce labeling strictly and with a reduced burden of proof for misbranding The FDA now only had to show that a product's labeling was "false or misleading in any particular" However, dietary supplements and vitamins were left without special regulations under the 1938 Act They were therefore regulated either as conventional food or food for special dietary purposes
Recognize the legal definition of terms such as "cosmeceutical" and "nutraceutical"
Some terms used widely in the marketplace have NO legal definition - "cosmeceutical", "nutraceutical" Per FDA: Terms such as "functional foods" or "nutraceuticals" are widely used in the marketplace. Such foods are regulated by FDA under the authority of the Federal Food, Drug, and Cosmetic Act, even though they are not specifically defined by law
Be familiar with US Dietary Guidelines: what are they, how are they derived, what are they based on, are they mandated by law, which agencies are involved?
The Dietary Guidelines is required under the 1990 National Nutrition Monitoring and Related Research Act The Act states that every 5 years, the U.S. Departments of Health and Human Services (HHS) and of Agriculture (USDA) must jointly publish a report containing nutritional and dietary information and guidelines for the general public The 2015-2020 Dietary Guidelines provides five overarching Guidelines that: Encourage healthy eating patterns Recognize that individuals will need to make shifts in their food and beverage choices to achieve a healthy pattern Acknowledge that all segments of our society have a role to play in supporting healthy choices.
Understand the conditions which dietary supplements that contain NDI's must meet in order to avoid being deemed adulterated under FDCA
The FD&C Act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under FDCA unless it meets one of two requirements: -The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; OR -There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe
Be familiar with various factors that can be used to distinguish beverages (conventional foods) from liquid dietary supplements
The most obvious representations about a product's use are claims made for the product in its labeling and advertising.
Understand how definitions found in legislation are used variously by consumers, industry and regulatory agencies
Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.
Be familiar with the purpose and role played by the Dietary Supplement Ingredient Advisory List. Who is it targeted to? Who can benefit from it?
is launching a new tool to quickly alert the public when we become aware of ingredients that appear to be unlawfully marketed in dietary supplements. -Consumers may wish to avoid buying and using dietary supplements containing ingredients on the List -Industry may wish to avoid making or selling dietary supplements containing ingredients on the List
Recognize how amendments modify laws - complete revision of the original law or new layers of information dealing with a specific topic?
new layers of information dealing with a specific topic
Recognize the series of events that prompted the passage of DSHEA
public health threat in 1989 from Japanese-made L-tryptophan, which contained an impurity that resulted in 1,536 people hospitalized with an otherwise rare condition (eosinophila-myalgia syndrome, or EMS, which can affect multiple organs - FDA became very concerned and established a task force to take a closer look at dietary supplements Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994 - partially to prevent a major FDA clampdown on the dietary supplement industry (Orrin Hatch, R-UT)
