I received a call in a late evening few days ago from an elderly family friend. She told me that she just got a bottle of “colon health” from pharmacy for prolonged constipation and asking if this drug would work well? After I said that this product is a supplement, not a drug, and she may not expect a quick resolution for her current situation, she was in a disbelieve. Then, she asked “what is a supplement?”
What are the dietary supplements?
Dietary supplements include vitamins, minerals, herbs, botanicals, enzymes, amino acids, or other dietary ingredients. You take these products by mouth in pill, capsule, tablet, or liquid form to supplement your diet. A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption.
Who may needs for dietary supplements?
Most people don't need to take vitamin supplements and are able to get all the vitamins and minerals they need by eating a healthy, balanced diet. Special populations may have needs for supplement, such as folic acid in pregnancy, Vitamin D for children and menopausal women, your diet limits certain food intake causing nutrients deficit, or recommendations from your doctor based on your health conditions. However, more than half of all Americans take one or more dietary supplements daily or on occasion. People take these supplements to make sure they get enough essential nutrients and to maintain or improve their health, although there is no data supports increase supplements intake will results in better health outcomes.
Regulatory background
If you are taking or thinking of taking dietary supplements for any reason, learn the regulatory background and better understand the dietary supplement marketplace would benefit your informed decision making.
What is over-the counter (OTC) drug?
It is important to recognize even though no prescriptions are needed for OTCs, these are still medicines that are to be taken according to the package instructions. OTCs are meant to treat minor health problems that can be managed at home, if the symptoms do not improve, medical attention is needed.
It’s easily get confused with OTC and supplement in the store, looking at the bottles on the shelves. It is easy to become overwhelmed by the vast array of dietary and sports supplements available in the marketplace. The supplement labels claim certain attractive health benefits. Unlike medicines, supplements can’t claim to diagnose, treat, cure, or prevent a disease. Read the labels carefully.
Considerations for dietary supplement use
What are the dietary supplements?
Dietary supplements include vitamins, minerals, herbs, botanicals, enzymes, amino acids, or other dietary ingredients. You take these products by mouth in pill, capsule, tablet, or liquid form to supplement your diet. A supplement can provide nutrients either extracted from food sources or synthetic, individually or in combination, in order to increase the quantity of their consumption.
Who may needs for dietary supplements?
Most people don't need to take vitamin supplements and are able to get all the vitamins and minerals they need by eating a healthy, balanced diet. Special populations may have needs for supplement, such as folic acid in pregnancy, Vitamin D for children and menopausal women, your diet limits certain food intake causing nutrients deficit, or recommendations from your doctor based on your health conditions. However, more than half of all Americans take one or more dietary supplements daily or on occasion. People take these supplements to make sure they get enough essential nutrients and to maintain or improve their health, although there is no data supports increase supplements intake will results in better health outcomes.
Regulatory background
If you are taking or thinking of taking dietary supplements for any reason, learn the regulatory background and better understand the dietary supplement marketplace would benefit your informed decision making.
- Supplements encompass a wide spectrum of products, including vitamins, minerals, herbs, or other botanicals, and amino acids. Generally speaking, the FDA classified supplements as foods, not drugs. Dietary supplements as a special subcategory of food, to fall under DSHEA (Dietary Supplement Health and Education Act) and regulated differently from drugs.
- Dietary supplement products are not reviewed by the FDA before they are marketed. As compared to prescription drugs, the FDA has limited oversight over supplements. The FDA only review the product for safety; not evaluate the supplement's effectiveness. A claim of benefits may be based on weak science. In addition, supplements you buy from stores or online may differ in important ways from products tested in studies.
- The Federal Trade Commission, not the FDA, has primary responsibility for overseeing claims related to supplements in print and broadcast ads, infomercials, catalogs, and direct marketing materials. Dietary ingredients are held to far lower standards than drugs. Supplement advertisements are frequently characterized by poorly supported claims of benefits and understate of potential hazards.
- Given the FDA's more limited role in the regulation of supplements, the burden falls more heavily on consumers to trust the manufacturer is reliable and to talk with their doctors about the unclear benefits and potential risks that supplements may offer. Unfortunately, information from the manufacturer are often promotional and some doctors may not knowing every supplements varieties.
- The dietary supplement is a profitable business and the marketplace is full of promotional advertising. In fact, dietary supplements are not super power for muscle building, weight loss, anti-aging, prevention or treatment of health conditions. More vitamins and minerals may not serve your body better, but with potential risks. With good wellness intentions, consumers are generally unaware of disclaimers on dietary supplements and over trusted manufacturer’s label languages when making decisions to purchase or use products. Even highly educated consumers are subject to placebo effects and the distortions that placebo effects and other psychological biases can have on consumer's ability to properly evaluate the efficacy of products.
What is over-the counter (OTC) drug?
- OTC drugs do NOT require a doctor's prescription
- OTCs are bought off-the-shelf in stores
- Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."
It is important to recognize even though no prescriptions are needed for OTCs, these are still medicines that are to be taken according to the package instructions. OTCs are meant to treat minor health problems that can be managed at home, if the symptoms do not improve, medical attention is needed.
It’s easily get confused with OTC and supplement in the store, looking at the bottles on the shelves. It is easy to become overwhelmed by the vast array of dietary and sports supplements available in the marketplace. The supplement labels claim certain attractive health benefits. Unlike medicines, supplements can’t claim to diagnose, treat, cure, or prevent a disease. Read the labels carefully.
Considerations for dietary supplement use
- Regulations ensure that herbal supplements meet manufacturing standards but don't guarantee that they're safe or effective.
- Dietary supplements are not drugs. It is not intended to diagnose, treat, cure, or prevent any disease.
- Dietary supplements are intended to supplement the diets of special needs, but not to replace the balance of the variety of foods important to a healthy diet. Quality food intake is the best source for nutrition and well-being.
- Determine your dietary supplement needs. Discuss supplement use with your Doctor or healthcare professionals, for unbiased evaluation on benefits and risks, drug and food interactions, and the product specific review. Do your homework before you buy.
- Advertising is highly strategic and very powerful in every channel today – TV, radio, print, digital, e-mail, social media, etc. Be aware of photogenic effects and commercial traps. Check NIH dietary supplement fact sheets and science evident resources for informed decision making.
- When shop on-line, use reliable website and be aware of promotional noises. Data presentation with biased intentions from seller or interested parties can be very sound and misleading. In case that it claims benefit for everything and everyone, it probably exaggerated or unrealistic.
- Assumptions such as “natural supplement can’t be harmful” or “the product must be safe if it’s sells on the market” are simply not true. Unlike the drugs, supplements do not receive pre-marketing approval from the FDA and supplements were not evaluated for effectiveness when marketed. The FDA has the authority to remove a supplement from the market if it's determined unsafe.
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Summary
In summary, dietary supplements are not drugs. It is not intended to diagnose, treat, cure, or prevent any disease. Dietary supplements include vitamins, minerals, herbs, botanicals, enzymes, amino acids, or other dietary ingredients. You take these products by mouth in pill, capsule, tablet, or liquid form to supplement your diet. Most people don't need to take vitamin supplements and are able to get all the vitamins and minerals they need by eating a healthy, balanced diet. Dietary supplements are intended to supplement the diets of special needs or deficits, but not to replace the balance of the variety of foods important to a healthy diet. Quality food intake is the best source for nutrition and well-being. |
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Reference
The FDA and Prescription Drugs: Current Controversies in Context, Supplements, Harvard University
https://nccih.nih.gov/health/supplements/wiseuse.htm
https://www.webmd.com/vitamins-and-supplements/supplement-faq
https://en.wikipedia.org/wiki/Dietary_supplement
https://www.nhs.uk/common-health-questions/food-and-diet/do-i-need-vitamin-supplements/
https://www.fda.gov/food/information-consumers-using-dietary-supplements/tips-dietary-supplement-users
https://ods.od.nih.gov/factsheets/list-all/
https://endpoints.elysiumhealth.com/fda-disclaimer-explained-5738f7aba0d5
https://www.fda.gov/drugs/questions-answers/prescription-drugs-and-over-counter-otc-drugs-questions-and-answers
This information is for educational and informational purposes only. It is not medical advice. Consult your healthcare professional for personal conditions.
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Disclaimer: This information is for educational and informational purposes only. It is not medical advice. Consult your healthcare professional for personal conditions.
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To support healthy aging, all helps are sincerely appreciated. We hope more people to share the benefits and making contributions to support continued health coaching education and services from Quality Life Forum. You can help now by sharing [passing on QLF valuable health coaching resource for other’s benefit] and giving [click here for a donation in any amount]. Your help will benefit many others life and make you feel great for your kind act of giving.
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