Industry Websites
“I need that link right now!”
There are a handful of vital organizations in our industry that are critical for education, legislation guidance, and industrial standards.
For your convenience, we have organized both a list of both Government and Industry Organizations’ websites with quick links to their latest updates.
Quick Links
Click on Subject title for More Information.
NEW FDA NDI DECISION CHART ON NEW INGREDIENTS
JULY 2011 – This guidance is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as “NDI notifications”). The guidance addresses in question and answer format what qualifies as a NDI, when a NDI notification is necessary, the procedures for submitting a NDI notification, the types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and what should be included in a NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement. The agency encourages manufacturers and distributors to consult this guidance during their safety review of a dietary supplement that contains a NDI and in preparing NDI notifications.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe 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 guidances means that something is suggested or recommended, but not required.
FDA: New Dietary Ingredients in Dietary Supplements
The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the Food and Drug Administration about these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
FDA: Dietary Supplements – Guidance Documents
Guidance documents contain nonbinding recommendations.
- Current Good Manufacturing Practice (CGMP)
- Labeling and Regulation
- Health Claims
- Qualified Health Claims
- Adverse Events Reporting Reporting an Adverse Event at a Glance (August 9, 2011)
Food Safety Modernization Act (FSMA)
JANUARY 2011 – The Food Safety Modernization Act directs the FDA to better monitor the rapidly expanding number of foreign food suppliers.
On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law and marked the most significant change in U.S. food safety law since the passage of the Food Drug and Cosmetic Act (FD&C Act) in 1938. Since the FDA is responsible for ensuring the safety of 80% of the U.S. food supply, the new law will impact the daily operations of many food companies, both foreign and domestic, as well as the dietary supplement industry.
Current Good Manufacturing Practices (cGMPs) Dietary Supplements
The U.S. Food and Drug Administration established regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D
The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.
CFR – Code of Federal Regulations Title 21
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA).
- Subpart A–General Provisions
- Subpart B–Personnel
- Subpart C–Physical Plant and Grounds
- Subpart D–Equipment and Utensils
- Subpart E–Requirement to Establish a Production and Process Control System
- Subpart F–Production and Process Control System: Requirements for Quality Control
- Subpart G–Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
- Subpart H–Production and Process Control System: Requirements for the Master Manufacturing Record
- Subpart I–Production and Process Control System: Requirements for the Batch Production Record
- Subpart J–Production and Process Control System: Requirements for Laboratory Operations
- Subpart K–Production and Process Control System: Requirements for Manufacturing Operations
- Subpart L–Production and Process Control System: Requirements for Packaging and Labeling Operations
- Subpart M–Holding and Distributing
- Subpart N–Returned Dietary Supplements
- Subpart O–Product Complaints
- Subpart P–Records and Record Keeping
Dietary Supplement Health and Education Act of 1994 (DSHEA)
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Under DSHEA, a firm 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. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. (See Current Good Manufacturing Practices (CGMPs) – Dietary Supplements) These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.
In the United States, a dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients:
- a vitamin
- a mineral
- a herb or other botanical (excluding tobacco)
- an amino acid
- a concentrate, metabolite, constituent, extract, or combination of any of the above
Government
Click on Government Name to Visit their Website.
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important discoveries that improve health and save lives.
Thanks in large part to NIH-funded medical research, Americans today are living longer and healthier. Life expectancy in the United States has jumped from 47 years in 1900 to 77 years today, and disability in people over age 65 has dropped dramatically in the past 3 decades. In recent years, nationwide rates of new diagnoses and deaths from all cancers combined have fallen significantly.
Office of Dietary Supplements (ODS) at the NIH
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD 20892-7517
The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.
U.S. Food and Drug Administration (FDA)
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
Federal Trade Commission (FTC)
600 Pennsylvania Avenue, NW
Washington, DC 20580
(202) 326-2222
The FTC deals with issues that touch the economic life of every American. It is the only federal agency with both consumer protection and competition jurisdiction in broad sectors of the economy. The FTC pursues vigorous and effective law enforcement; advances consumers’ interests by sharing its expertise with federal and state legislatures and U.S. and international government agencies; develops policy and research tools through hearings, workshops, and conferences; and creates practical and plain-language educational programs for consumers and businesses in a global marketplace with constantly changing technologies.
Organizations
Click on Organization Name to Visit their Website. Your PNI Sales Executive can provide referrals for legal council familiar with our industry.
Alliance for Natural Health
1350 Connecticut Ave NW, 5th Floor
Washington, DC 20036
The Alliance for Natural Health USA (ANH-USA)*, is part of an international organization dedicated to promoting sustainable health and freedom of choice in healthcare through good science and good law. We protect the right of natural-health practitioners to practice and the right of consumers to choose the healthcare options they prefer. Since 1992, we have worked to shift the medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an “integrative” approach incorporating functional foods, dietary supplements, and lifestyle changes. We believe this is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.
American Academy of Anti-Aging Medicine (A4M)
1510 W. Montana Street – Chicago Office
Chicago, IL 60614
The American Academy of Anti-Aging Medicine (A4M) is a US federally registered 501(c) 3 non-profit organization comprised of 22,000-plus member physicians, health practitioners, scientists, governmental officials, and members of the general public, representing over 105 nations.
The A4M is dedicated to the advancement of technology to detect, prevent, and treat aging related disease and to promote research into methods to retard and optimize the human aging process. The A4M is also dedicated to educating physicians, scientists, and members of the public on biomedical sciences, breaking technologies, and anti-aging issues.
American College for Advancement in Medicine (ACAM)
8001 Irvine Center Drive, Suite 825
Irvine, CA 92618
The American College for Advancement in Medicine (ACAM) is a not-for-profit Organziation dedicated to educating physicians and other health care professionals on the safe and effective application of integrative medicine. ACAM’s healthcare model focuses on prevention of illness and a strive for total wellness. ACAM is the voice of integrative medicine; our goals are to improve physician skills, knowledge and diagnostic procedures as they relate to integrative medicine; to support integrative medicine research; and to provide education on current standard of care as well as additional approaches to patient care.
PO Box 144345
Austin, TX 78714-4345
At the American Botanical Council, we are passionate about helping people live healthier lives through the responsible use of herbs, medicinal plants. We are an independent, nonprofit research and education organization dedicated to providing accurate and reliable information for consumers, healthcare practitioners, researchers, educators, industry and the media.
American Herbal Products Association
8630 Fenton Street, Suite 918
Silver Spring, MD 20910
By joining the American Herbal Products Association, your company will benefit from nearly three decades of leadership in the herbal products industry. From the US Congress, to numerous regulatory agencies, to scientific meetings and the media, AHPA is there to represent the herbal products industry. While you invest in growing your business, let AHPA represent those interests that are important to the entire trade, as we have done so successfully for almost 30 years.
AHPA exists to promote the responsible commerce of herbal products. AHPA’s activities are undertaken to maintain and improve market opportunities for companies that sell herbs and herbal products, and to ensure that consumers continue to enjoy informed access to a wide choice of goods. Even though AHPA is known as the “herbal” trade association, our influence extends to the entire dietary supplement category and we are always working to ensure a healthy regulatory and business environment for the entire range of health-related products. When new laws and regulations are being debated, you can rest assured that AHPA is in the room to represent the needs of your company. AHPA will also keep you informed of new and important developments that affect this industry.
Council for Responsible Nutrition
1828 L Street, NW, Suite 510
Washington, DC 20036-5114
The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing dietary supplement manufacturers and ingredient suppliers. CRN companies produce a large portion of the dietary supplements marketed in the United States and globally. Our member companies manufacture popular national brands as well as the store brands marketed by major supermarkets, drug store and discount chains. These products also include those marketed through natural food stores and mainstream direct selling companies. In addition to complying with a host of federal and state regulations governing dietary supplements, our 70+ manufacturer and supplier members also agree to adhere to voluntary guidelines for manufacturing, marketing and CRN’s Code of Ethics.
http://www.integrativepractitioner.com
IntegrativePractitioner.com represents a collaborative effort between many generous and esteemed organizations and individuals who support the integrative healthcare model. Our goal is to support the wide spectrum of integrative healthcare professionals in becoming more successful in their practices in order to effect positive improvements in the current standards of healthcare, policy and to strengthen the common ground among all constituents. To support these efforts, the site will be the destination for business networking relationships among companies and practitioners.
Institute of Food Technologists
525 W. Van Buren, Suite 1000
Chicago, IL 60607
Feeding the minds that feed the world.
Envision what the very best minds in food science can achieve when they work together: providing each and every person on the planet with access to a safe and abundant food supply. For more than 70 years, the Institute of Food Technologists (IFT) has been unlocking the potential of the food science community by creating a dynamic global forum where members from more than 100 countries can share, learn, and grow. We’ve helped the members of this community connect both in person, through scientific and technical education venues and forums such as the world’s largest annual food expo, and virtually, through our publications and other resources.
By serving as a leading advocate for food science and a catalyst for change around the world, we’ve educated the media and policy makers and worked with governments to shape regulations
Natural Products Association
1773 T Street, NW
Washington, DC 20009
Founded in 1936, the Natural Products Association is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. The Natural Products Association represents over 1,900 members accounting for over 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids.
NPA unites a diverse membership, from the smallest health food store to the largest dietary supplement manufacturer.
NPA is recognized for its strong lobbying presence in Washington, D.C., where it serves as the industry watchdog on regulatory and legislative issues. In 1994, NPA played a key role in the passage of the Dietary Supplement Health and Education Act (DSHEA). This important legislation strikes a balance between the need for consumers to have access to and information about safe and effective dietary supplements while also preserving the government’s interest in protecting the public from unsafe products and false and misleading claims.
Natural Products Foundation
1773 T Street, NW
Washington, DC 20009
The Natural Products Foundation is organized exclusively to stimulate and support research, education and knowledge regarding dietary supplements, nutritional foods, and related products, with the overall objective of advancing the knowledge of the public, and thereby, improving the public health.
The Natural Products Foundation is chartered as a not-for-profit 501 (c) (3) Corporation. Depending on the status of the donor (i.e., individual or corporation) all or part of contributions to the foundation are tax-deductible.
NSF International
P.O. Box 130140
789 N. Dixboro Road
Ann Arbor, MI 48113-0140, USA
NSF International, The Public Health and Safety Company™, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education, and risk-management for public health and safety. For 65 years, NSF has been committed to public health, safety, and protection of the environment. While focusing on food, water, indoor air, and the environment, NSF develops national standards, provides learning opportunities, and provides third-party conformity assessment services while representing the interests of all stakeholders. The primary stakeholder groups include industry, the regulatory community, and the public at large.
The American Association of Naturopathic Physicians (AANP)
4435 Wisconsin Avenue, NW, Suite 403
Washington, DC 20016
Founded in 1985, the American Association of Naturopathic Physicians (AANP) is the national professional society representing licensed or licensable naturopathic physicians who are graduates of four-year, residential graduates programs. Each of the seven schools in North America is either accredited by an agency of the United States Department of Education.
Located in Washington, D.C., the AANP has 38 official State Affiliates across the country. Our membership consists of more than 2000 students, physicians, supporting and corporate members who collectively strive to expand access to naturopathic medicine nationwide.
The Institute for Functional Medicine (IFM)
4411 Pt. Fosdick Dr. NW, Suite 305
Gig Harbor, WA 98335
In 1990 Jeffrey Bland created the concept of Functional Medicine as a discipline that married progress in basic medical sciences with clinical medicine to address the growing problems associated with chronic disease. In 1991 Jeffrey and Susan Bland founded and funded the Institute for Functional Medicine with the mission to both educate and provide clinical support for the implementation of medicine across disciplines within the health care sector for functional medicine. The charter of the Institute for Functional Medicine was conceived by its founders as a systems biology approach to the prevention and management of chronic disease utilizing the appropriate facets of nutrition, lifestyle, exercise, environment, structural, cognitive, emotional and pharmaceutical therapies to meet the individual needs of the patient.
