USP-verified Omega-USP™ fish oils are safe, pure and tested
When it comes to fish oil, only the best made in North America makes sense.
We make many references on this website to the term "USP-verified". We do so because we believe it's the most important guarantee of fish oil supplement quality currently available.
The material that follows has been taken from the USP web site so as to give you the whole story in one place. It makes clear why we believe the USP-verified designation is a highly credible third-party assessment of purity and quality.
The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States.
USP also sets:
- widely recognized standards for food ingredients and dietary supplements:
- standards for the quality, purity, strength, and consistency of these products–critical to the public health.
USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
The USP Mission
USP's mission is to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
The USP Staff
USP is a nonprofit public health organization whose work is accomplished by a body of more than 1,000 volunteer experts who work under USP's strict conflict–of–interest rules to set its scientific standards.
USP's contributions to public health are enriched by the participation and oversight of these volunteers who represent pharmacy, medicine, and other healthcare professions as well as academia, government, the pharmaceutical and food industries, health plans, and consumer organizations.
USP's volunteers and standards–setting processes are supported by more than 500 USP staff members, who work at USP's five locations: Rockville, MD, USA (Headquarters); Basel, Switzerland; Hyderabad, India; Shanghai, China; and São Paulo, Brazil.
USP Programs and Services
USP's activities have a significant impact on promoting quality and protecting the public health worldwide. Programs and services include:
- Product Quality–Documentary Standards
- Medicines and Dietary Supplements
- Food Ingredients
- Product Quality–Reference Standards
- Product Quality–Verification Services
- Education and Events
- Healthcare Quality and Safety
- Promoting Drug Quality in Developing Countries
What is 'USP Verified'?
USP verifies the quality, purity, and potency of dietary supplement finished products, dietary supplement ingredients, and pharmaceutical ingredients.
Products and ingredients that pass all USP verification requirements—including a GMP audit, product and ingredient testing, and manufacturing documentation review—are awarded the distinctive USP Verified Mark. Participation is voluntary and available to manufacturers worldwide.
USP's verification services draw upon its experience of nearly 200 years in setting federally recognized public standards of quality for medicines and, more recently, dietary supplements that are used today in more than 130 countries around the world.
The USP Verified Mark and what it means
Products that meet the program's stringent criteria are awarded the distinctive USP Verified Mark for use on labels, packaging, and promotional materials. The Mark makes it easy for customers, healthcare practitioners, and retailers to identify USP Verified products. Seeing the USP Verified Mark on a label indicates that the dietary supplement product inside
- Contains the ingredients listed on the label, in the declared potency and amounts. Tests have shown that contents of some supplements don't match the label and some contain significantly less or more than the claimed amount of key ingredients. There may be health risks when supplements taken for a specific health condition do not contain ingredients in appropriate quantities. USP Dietary Supplement Verification helps assure customers that they are getting the value they expect from a product they are purchasing.
- Does not contain harmful levels of specified contaminants. Some supplements have been shown to contain harmful levels of certain heavy metals (e.g., lead and mercury), pesticides, bacteria, molds, toxins, or other contaminants. At specific levels these contaminants can pose serious risks to one's health.
- Will break down and release into the body within a specified amount of time If a supplement does not break down properly to allow its ingredients to dissolve in the body, the consumer will not get the full benefit of its contents. USP Dietary Supplement Verification tests products against federally-recognized dissolution standards.
- Has been made according to FDA current GMPs using sanitary and well-controlled procedures. Assurance of safe, sanitary, well-controlled, and well-documented manufacturing and monitoring processes indicates that a supplement manufacturer is quality-conscious and concerned for public well-being.
USP Verified Dietary Supplement Ingredients
USP verifies active and inactive ingredients used in the manufacture of dietary supplement products. Ingredients that pass USP's rigorous verification processes are awarded use of the USP Verified Dietary Supplement Ingredient Mark (image on right) to display on containers of the verified ingredient. The mark helps manufacturers recognize that they are buying ingredients of consistent quality for use in the supplements they manufacture.
USP Verified Pharmaceutical Ingredients
USP verifies drug substances and excipients used to make over-the-counter and prescription pharmaceuticals. Ingredients that meet USP's strict verification requirements are awarded use of the USP Verified Pharmaceutical Ingredient Mark (image on right) to display on containers of the verified ingredient. The mark assures manufacturers, and regulatory authorities that an ingredient is of consistent, high quality.
USP Verified Dietary Supplements
USP verifies the quality, purity, and potency of dietary supplement finished products. Only those that meet USP's stringent criteria are warded use of the USP Verified Dietary Supplement Mark to display on their product labels (image on right). Finding this mark on a dietary supplement label helps to assure consumers that the supplements they buy provide the expected value.
- Drug Substance Verification Features
- Audits of each manufacturing site for compliance with the International Conference on Harmonization's ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Review of manufacturing and QC documents
- Laboratory testing of drug substance samples from selected lots for compliance with labeling and certificate of analysis claims and program requirements
- Post-verification surveillance testing, audits, and change notification activities are conducted to ensure that the drug substance continues to meet program requirements
- Excipient Verification Features
- Audits of each manufacturing site for compliance with USP General Chapter <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients and International Pharmaceutical Excipients Council's IPEC/PQG GMP Guide for Pharmaceutical Excipients
- Review of manufacturing and QC documents
- Laboratory testing of excipient samples from selected lots for compliance with labeling and certificate of analysis claims and program requirements
- Post-verification surveillance testing, audits, and change notification activities are conducted to ensure that the excipient continues to meet program requirements
The USP Dietary Supplement Verification Program
The USP Dietary Supplement Verification Program is a voluntary testing and auditing program that helps dietary supplement manufactures ensure the production of quality products for consumers. Available worldwide, the program verifies the quality, purity, and potency of dietary supplement finished products through the following processes:
- comprehensive laboratory testing of dietary supplement products and their ingredients against dietary supplement standards found in The United States Pharmacopeia and The National Formulary (USP–NF)
- a thorough manufacturing and quality control document review
- an on-site manufacturing facility audit for compliance with USP standards and FDA current Good Manufacturing Practices (21 CFR Part 111)
- random off-the-shelf testing to confirm that USP Verified products continue to meet USP's strict standards.
USP and Consumers
Few Americans are aware that the USP) plays an important role in their general health and well–being.
While USP does not manufacture, sell, determine the safety of, or regulate medications, dietary supplements, or food ingredients, it does set standards so that there is uniform, consistent quality that consumers can confidently expect when they buy and use these products.
As a nonprofit, scientific organization, USP is in a unique position. It can collaborate with industry, governments, academic institutions, healthcare practitioners, and consumer groups from around the world to set standards that are in the public's best interest. USP standards are relied upon in the United States and in more than 130 countries.
Information on USP activities and their impact on consumers and public health, follow here:
For nearly 200 years, USP has set scientifically developed standards that help to ensure that over–the–counter and prescription medicines are of high quality, are pure, are of the appropriate and expected strength, and are consistent from one pill, bottle, shelf, and pharmacy to the next.
Once USP develops a drug standard and it becomes official, it is enforceable by the Food and Drug Administration (FDA), and all manufacturers of that drug must comply with the USP standard if they wish to import it to or market it in the United States.
It is important to note that USP does not approve a drug for sale in the U.S. market nor does it make decisions about a drug's safety or efficacy—these are also responsibilities of FDA.
Updating Standards for "At Risk" Medications
An important and emerging activity for USP is updating standards for drugs that are considered "at risk" for adulteration.
In the modern, global manufacturing environment, drugs and their ingredients are produced all over the world. In some instances, counterfeiters have adulterated medicines by substituting lower–cost ingredients for higher–cost ones for their own economic gain—which can have serious and even fatal consequences for patients.
Adherence to USP's standards of quality is one of the safety nets that helps secure the drug supply.
Drug Classification for Medicare Prescription Drug Benefit
In addition to setting drug standards, under a Congressional mandate, USP has developed—and will continue to update—a drug classification system (the Medicare Model Guidelines) for the Medicare prescription drug benefit program. This classification system provides a framework that pharmaceutical benefit managers and prescription drug plan sponsors can use in determining medicines approved for coverage under Medicare.
USP Drug Quality and Information Program (USP DQI)
USP DQI is a program supported by the U.S. Agency for International Development that focuses on improving drug quality and appropriate drug use in developing countries through education, access to current drug information, and technical leadership. Since the program began in 2000, USP DQI has established a presence in countries on four continents and has addressed issues such as counterfeit drugs in Asia and Africa and an inadequate anti–malarial drug supply in the Amazon Basin.
USP sets standards for dietary supplements (including vitamins, minerals, botanicals, and herbals) that are recognized in U.S. federal law per the Dietary Supplement Health and Education Act, an amendment to the U.S. Food, Drug, and Cosmetics Act. FDA regulations for dietary supplements are very different than those for drugs; manufacturers may voluntarily choose to meet USP standards but are not required to do so. However, under the law, products that claim to conform to USP standards on their labels must do so or they may be deemed to be misbranded per FDA regulations.
USP Verified Dietary Supplements
In addition to setting standards, USP offers a voluntary program for manufacturers that "verifies" or confirms the quality of a product's ingredients and its manufacturing processes.
Products that meet USP's stringent testing and evaluation criteria are awarded the USP Verified Mark for use on product labels, packaging, and promotional materials.
The USP Verified Mark helps assure consumers of a manufacturer's commitment to quality and helps them easily identify and choose a product that:
- contains the ingredients listed on the label, in the declared potency and amount
- does not contain harmful levels of specified contaminants
- will break down and release into the body in a specified amount of time
- and has been made according to the FDA's Good Manufacturing Processes
In light of recent FDA actions and news reports about sub–standard dietary supplement products, this added assurance of quality is important, especially to consumers who may rely on supplements to generally enhance their health, or to meet a specific dietary need based on a vitamin deficiency or situation such as pregnancy.
USP began establishing standards of quality for food ingredients when it acquired The Food Chemicals Codex (FCC) from the Institute of Medicine (IOM) in 2006. Published since 1966 by IOM, the FCC contains standards for the purity and identity of food ingredients that are used by manufacturers around the world. While FCC standards are intended for industry use, they help manufacturers supply food ingredients and finished products to consumers that are of consistent and uniform quality.
As the global marketplace for food ingredients continues to expand, increasing attention is being paid to food ingredient quality and critical issues such as adulteration and contamination. USP is committed to helping the food ingredient industry combat these issues by continuing to revise and update FCC standards to meet contemporary needs. While FCC standards are not enforced in the United States like USP drug standards, they can serve as a legal requirement for manufacturing or importing a food ingredient in other countries, and they can play an important role in helping a manufacturer demonstrate self–regulation and quality assurance.
What makes the USP program unique?
A nonprofit federally recognized standards-setting organization, USP is the only such organization that also offers voluntary verification services. USP's expertise in the field stems from its nearly 200 years of experience establishing standards of quality for medications and, more recently, dietary supplements and food ingredients. USP standards are in use in more than 130 countries and are federally recognized per the Federal Food, Drug and Cosmetic Act and the Dietary Supplement Health and Education Act.
We hope you now understand why we put such faith in supplements such as Numedica's Omega USP™ fish oils that are USP-verified or contain USP-verified ingredients. The act of seeking verification is evidence of the integrity of the supplier.
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