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Frequently Asked Questions (FAQ)

Q. How do I know if I need a dietary supplement?

A. Because many products are marketed as dietary supplements, it is important to remember that supplements include vitamins and minerals, as well as herbs, botanicals and other substances.

Some supplements may help ensure that you get adequate amounts of essential nutrients or help promote optimal health and performance if you do not consume a variety of foods, as recommended in the MyPlate and Dietary Guidelines for Americans.

However, dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

 

Q. Where can I find information about the use of dietary supplements for a particular health condition or disease?

A. Scientific evidence supporting the benefits of some dietary supplements (e.g., vitamins and minerals) is well established for certain health conditions, but others need further study. Whatever your choice, supplements should not replace prescribed medications or the variety of foods important to a healthful diet.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In some cases, dietary supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions.

Do not self diagnose any health condition. Work with your health care provider to determine how best to achieve optimal health and always check with your health care provider before taking a supplement, especially when combining or substituting them with other foods or medicine.

In addition to talking with your health care provider about dietary supplements for a particular health condition or disease, you can search on-line for information. It is important to ensure that you obtain information from reliable sources such as:

 

Q. What is the difference between the RDA and DV for a vitamin or mineral?

Many terms are used when referring to either the amount of a particular nutrient (such as calcium or vitamin D) you should get or the amount in a food or dietary supplement. The two most common are the Recommended Dietary Allowance (RDA) and the Daily Value (DV). These terms can be confusing.

RDAs are recommended daily intakes of a nutrient for healthy people. They tell you how much of that nutrient you should get on average each day. RDAs are developed by the Food and Nutrition Board at the Institute of Medicine of the National Academies. They vary by age, gender and whether a woman is pregnant or breastfeeding; so there are many different RDAs for each nutrient.

DVs, established by the U.S. Food and Drug Administration (FDA), are used on food and dietary supplement labels. For each nutrient, there is one DV for all people ages 4 years and older. Therefore, DVs aren't recommended intakes, but suggest how much of a nutrient a serving of the food or supplement provides in the context of a total daily diet. DVs often match or exceed the RDAs for most people, but not in all cases.

DVs are presented on food and supplement labels as a percentage. They help you compare one product with another. As an example, the %DV for calcium on a food label might say 20%. This means it has 200 mg (milligrams) of calcium in one serving because the DV for calcium is 1,000 mg/day. If another food has 40% of the DV for calcium, it's easy to see that it provides much more calcium than the first food.

The FDA has a Web page that lists the DVs for all nutrients and provides additional details.

 

Q. Who is responsible for overseeing the regulation of dietary supplements in the United States?

A. In the United States, the U.S. Food and Drug Administration (FDA) has regulatory responsibility for dietary supplements. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature.

For more information, please contact the FDA Center for Food Safety and Applied Nutrition via their Web site or at 1-888-723-3366.

The Federal Trade Commission (FTC) regulates advertising of dietary supplements in national or regional newspapers and magazines; in radio and TV commercials, including infomercials; through direct mail to consumers; or on the Internet. The FTC requires that all information about supplements be truthful and not misleading.

For more information, please contact the FTC via their website.

 

Q. Where can I locate information or data on dietary supplement sales and usage?

A. The Office of Dietary Supplements (ODS) does not track dietary supplement sales or usage. You can search for publications on these topics through databases of medical and scientific literature:

In addition to searching for scientific publications, you may wish to contact market research companies that provide sales and marketing data for the nutrition industry. For example, the Nutrition Business Journal provides market data and analysis of the global nutrition industry, including dietary supplements.

 

Q. Are dietary supplements regulated by the FDA?

A. Dietary Supplements are regulated under the FDA through DSHEA (Dietary Supplement Health & Education Act of 1994).

 

Q. What is an I.U. compared to milligrams and micrograms?

A. IU stands for International Unit and is a standard and internationally accepted unit of measurement for vitamin A (and Beta-carotene), Vitamin D and Vitamin E. The remainder of vitamins and minerals are measured in milligrams (mg) or micrograms (mcg). Although IUs can be converted into mgs, most supplement labels as well as food labels will reflect the amount of these nutrients in IU.

 

Q. What is a Daily Value?

A. The Daily Value is the amount of a nutrient the body needs based on a 2000-calorie diet for an average sized person. There are two standards that are referenced as follows: 1. Daily Reference Values 2. Reference Daily Intakes (RDIs), which replaced the term “U.S. RDA” (the values determined by FDA and used on food labels, taken from the “RDAs” which are values determined by the National Academy of Sciences for various populations groups). The Daily Value (or a RDA's) is the minimal dosage intended to augment less than perfect eating habits (the Daily Values, are the values that will be seen on the labels). However, these values do not indicate what the safe maximum amount of a vitamin you can take, or amounts that may give therapeutic benefits, in addition to keeping the body from being deficient.

 

Q. Is there gluten in any Burts Remedies products?

A. Most all of our products are gluten free, and is stated as such on the label.

 

Q. From where do you source your ingredients?

A. : The path to quality products at Burts Remedies starts well before reaching our manufacturing centers. We source our ingredients globally, and only work with suppliers who meet our high-quality standards, in both process and ingredient sourcing, and we ensure the quality levels of each new supplier via audits conducted by ourselves or experts we select. This ensures that our suppliers have clean, compliant facilities that follow Good Manufacturing Practices (GMP). We also require our suppliers to provide a Certificate of Analysis (COA).

 

Q. Do you batch test all your products?

A. our products are batch tested before release.

 

Q. How long are samples retained?

A. Samples are retained for 3 years after the expiration date.

 

Q. What is your quality assurance?

A. At Burts Remedies, we understand the importance of quality and integrity to the longevity of a company. All our products are produced in an FDA-approved, GMP compliant facility that is licensed and inspected under state and federal health authorities.

 

Q. Do you have quality control?

A. All our products are produced while maintaining all documents, records and Standard Operating Procedures-, (SOP’s) making sure that they are up to date. All products are produced while monitoring all phases of production to assess performance and adherence to GMP and to the SOPs of each department.

 

Q. Do you qualify your suppliers?

A. All Burts Remedies products are produced while maintaining an audit program to verify the suppliers’ ability to provide consistent products that meet strict quality requirements. All incoming ingredients conform to standards of purity and effectiveness and meet or exceed the GMP guidelines. No ingredient is received at our manufacturing facility unless it is in accurately labeled packaging with tamper-evident seals. All incoming shipments must be accompanied by full documentation, including independent Certificate of Laboratory Analysis, and corresponding PO # (SIDI).

 

Q. Do you do ingredient and finished product testing?

A. All our products are made under FDA testing protocol per the new GMP Guidelines.  We are also improving our analytical laboratory testing procedures to assure the identity and potency of the ingredients in every Burts Remedies supplement. This includes full service testing, microbiological and stability studies.