Dietary Supplements Part I

What do you know about U.S. Dietary Supplements?

Dietary supplements include vitamins, minerals, fibers, herbs, extracts, botanical concentrates, amino acids, and enzymes. They are produced and marketed in the form of tablets, capsules, gums, gel capsules, powders, and liquids. 

Nutritional supplements can be useful for your health when it helps keep you healthy. They are used to facilitate the rapid recovery of dietary needs when a healthy diet is not possible for any circumstances or until the individual reaches the desired levels. You don’t need to continue taking supplements one you reach the objective.

The individuals who enjoy good health and have no deficiencies of any nutrient, don’t need nutritional supplements, a balanced and complete diet adjusted to the routine and daily physical activity of the individual, provides all the recommendations of nutrients and calories required. 

If you are not sure how your diet is, consult a Nutritionist- or an R.D.

The influence of advertising campaigns worldwide, social networks, the lack of accurate information, and the lack of knowledge about nutritional supplements, make healthy people consume regularly dietary supplements unnecessarily, exposing themselves to unnecessary risks.

Dietary supplements are not intended to treat, diagnose, mitigate, prevent, or cure disease. In many cases, nutritional supplements may have unwanted effects, especially if taken before surgery or with other dietary supplements or medicines, or if you have certain health conditions. Whatever your choice is, supplements should not replace prescribed medications or the variety of foods necessary for a healthy diet.

Adverse Effects from Dietary Supplements

  • itching, rash, hives, throat/lip/tongue swelling, wheezing
  • low blood pressure, fainting, chest pain, shortness of breath, palpitations, irregular heartbeat
  • severe, persistent nausea, vomiting, diarrhea, or abdominal pain
  • difficulty urinating, decreased urination
  • fatigue, appetite loss, yellowing skin/eyes, itching, dark urine
  • severe joint/muscle pain
  • slurred speech, one-sided weakness of the face, arm, leg, vision (stroke)
  • abnormal bleeding from nose or gums
  • blood in urine, stool, vomit, or sputum
  • marked mood, cognitive, or behavioral changes, thoughts of suicide
  • visit Emergency Room or hospitalization

Consumer Protection

The Food and Drug Administration – FDA does not approve nutritional Supplements of the United States- in compliance with the Health and Education Act for Dietary Supplements of 1994 – DSHEA. Therefore, manufacturers and distributors are the only responsible for ensuring that their products are safe and that the product declarations are accurate. 

Also, unlike for drugs, a dietary supplement doesn’t need research studies in people to prove its benefits before the supplement is in the market. It is the responsibility of manufactures/distributors to ensure that their products are safe and their label claims are accurate and truthful.

Manufacture can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem; however, they do not have to prove that the supplement is effective

Nutritional Supplements Consumers need to report to the manufacturer and the Federal Agency Administration – FDA any adverse effect for the presence of toxic ingredients or no result at all to control and monitor harmful side effects and false claims. 

If the FDA finds a supplement to be unsafe once it is on the market, they take action against the manufacturer and distributor, such as by issuing warning letters or requiring the product to be removed from the marketplace. This action is known as Recalls.

Any time that manufactures/distributors make a claim; they must add this statement:

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” 

If customers find that it doesn’t work, they need to report to the FDA and Manufacturer.

How do I know if the supplement that I purchased contains the ingredients that it claims on the label?

The FDA doesn’t analyze the content of dietary supplements. The FDA issues Good Manufacturing Practices (GMPs) for nutritional supplements as a set of requirements and expectations to manufacture, prepare, and stored to ensure quality.  

FDA’s GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.

Another point to consider is the term”standardized.” U.S. law does not define standardization. Therefore, the use of this term or “verified” or “certified” does not guarantee product quality or consistency.

If you have a question about a specific brand of dietary supplement, you need to call the manufacturer and ask to speak to someone who can address your interrogates. For example:

  1. What information does the firm have to prove the claims made for the product?
  2. Does the firm has information to share about the safety or efficacy of the ingredients in the product?
  3. Does the firm follow GMPs and have a quality control system in place?
  4. Has the firm received any adverse events reports from consumers using their products?

Prevention

  • Eat a balanced and complete diet
  • Report adverse events to the FDA or USDA
  • Investigate the toxicity of each ingredient
  • Investigate the integrity of the information
  • Investigate the nutritional value of the product
  • Consult with an experienced professional
To learn more about Dietary Supplements, continue reading “Dietary Supplements Risk, Part II”