There’s A Supplement for That!!

By Sally J. Feltner, M.S.,Ph.D

In 1994, Congress passed the Dietary Supplement Health and Education Act that loosened the regulation requirements that ultimately favored the manufacturers and led to an explosion of the dietary supplement market.
As a result, the FDA now has minimal regulation over testing prior to marketing concerning the safety or effectiveness of any supplement. Any testing is the responsibility of the manufacturer so it becomes difficult to “prove” any safety issues that may be present.

Since 1994, the FDA has taken action against many products because they contain prescription drugs or contaminants. Most of the products under scrutiny were labeled for use as sexual enhancement, body building, and weight loss.

Dietary Supplement Labeling:

Fortunately, what goes on the label is regulated. Structure/function claims can advertise  how the product affects normal body structures (such as “helps maintain strong bones”) or functions. Claims such as “improves circulation”, “prevents wrinkles” “supports the immune system”, and “helps maintain mental health” can be used, whereas “prevents heart disease”, “cures depression” cannot be.

If a function claim is made, the labeling has this warning: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” So who needs them?

Take the Case of Robert
Robert is 70 years old and has always been healthy. Recently, he experienced a few episodes of forgetfulness but thought nothing of it and attributed it to old age. Then he began feeling tired and having tingling in his hands and feet, difficulty walking, and diarrhea. He finally made a doctor’s appointment.

His blood test revealed he had a vitamin B12 deficiency and after a diet history, the doctor noticed he ate very little meat or dairy.  Due to his age, the doctor explained the deficiency could be caused by a condition common in older adults that reduces the ability to absorb  the vitamin and suggested he start to take a daily supplement containing the vitamin. He also gave him an injection of vitamin B12 in case the vitamin was not being adequately absorbed by Robert.

Who may benefit from vitamin and mineral supplements? 

  • People with a diagnosed vitamin and/or mineral deficiencies
  • Newborns (vitamin K)
  • Vegans (vitamin B12 and D)
  • Pregnant women (folate and iron)
  • Elderly persons on limited diets (multivitamin/minerals)
  • People on restricted diets (multivitamins/minerals)
  • People at risk for osteoporosis (calcium, vitamin D)
  • People with alcoholism (multivitamin/minerals)
  • Elderly people diagnosed with vitamin B12, vitamin D and/or folate deficit

Guidelines for Using Vitamin and Mineral Supplements
Purchase products with USP (U.S. Pharmacopeia or the CL symbol (Consumer Laboratories) – tested for purity, ingredients, and dose.
Choose supplements containing 100% of the Daily Value or less.
Take supplements with meals.
Tell your health care provider about the supplements you take. Some may affect your prescription medications.

Nonvitamin NonMineral Supplements

Fatty Acids: Omega-3’s, fish oils, DHA and EPA, flaxseeds

Claims: To reduce heart disease and enhance brain function. This claim has recently been disputed and needs further research as to its effectiveness.

Omega-3s compete with omega-6s (vegetable oils like corn oil, soybean oil, safflower seed oil) for conversion to eicosanoids that help regulate blood clotting, inflammation, and blood pressure in the body.
Problem: We have far more 6’s in the food supply than we have 3’s. They work best at a ratio of 4:1 but instead we have 20:1 in favor of 6’s.

Flaxseeds contain alpha-linolenic fatty acid that can be be converted to EPA and DHA in the body; but this is not very efficient in humans and decreases as we age. EPA and DHA are the active forms which can lower inflammation and blood clotting factors. That is why we should eat EPA and DHA directly from fish instead of relying on their conversion in the body from alpha-linolenic acid.

Bottom Line:

  • Found to not be very effective in reducing heart attacks in supplement form.
    Best to get them eating fatty fish 2-3 times a week. (salmon, trout, tuna)
    Possible problems with mercury and contaminants in fish (farmed and wild-caught
    Fish oil supplements not recommended for anyone taking blood thinner medications.

Enzyme Supplements

Enzymes are proteins that are  broken down in the small intestine to amino acids; thus, the original enzyme and its functions are not intact – so little if any effect can be gained from taking them in their enzyme form.

One exception: Some are made to work in the digestive tract before they are broken down. For example, lactase breaks down lactose and is helpful to people who are lactose intolerant.

So, if these are not specially coated to protect them as they are in cystic fibrosis, most enzyme supplements are totally useless to the body.  Healthy people make their own digestive enzymes in the pancreas and small intestine.

Hormone Supplements
Many marketed to athletes to replace the desirable steroid hormones that enhance muscle growth and strength and can be dangerous, like growth hormones. Again, without putting them to the test, there is no way to measure their safety or effectiveness.

Melatonin:
Not a protein, but a steroid hormone made in the pineal gland in the brain.
Marketed as a sleep aid and help with jet lag.
Claimed to improve sleep duration and quality
Somewhat effective
Dose is important – start low.

Coenzyme Supplements:
Coenzymes are enzyme helpers, such as coenzyme Q10.
Needed as an electron carrier in the final steps of energy (ATP) production
Are often claimed to be needed when statins are taken. .
This can cause side effects of statins of muscle pain and weakness.
Some studies show benefits of reduced pain – but not all

Herbal Remedies
As with all supplements, they are only as good if they are effective and safe (some are not). Human studies with herbal remedies have helped identify which herbals and supplements lack beneficial effects or have adverse effects. Some can pose a health risk. Results of most studies are mixed.

Guidelines for Herbal Use

  • Don’t use for serious, self-diagnosed conditions.
    Let your doctor know what herbals you take.
    Clear the use of herbal remedies with your doctor if you take prescription meds.
    Do not use if attempting or are pregnant.
    Don’t mix herbal remedies.
    If you are allergic to certain plants, make sure the same is not true of the chosen herbal supplement.
    Buy herbs with the USP label or have the CL label.

Functional Foods
Generally taken to mean food or food ingredients that may provide a health benefit beyond the effects of traditional nutrients it contains

Examples of functional foods with proposed health benefits include:

  • Stanol and sterol fortified margarines, psyllium fiber, whole oat products – reduced blood levels of LDL cholesterol
  • Omega-3 acids – reduce blood triglycerides – must be in high doses
  • Cranberry juice extracts – decreased urinary tract infections
  • Folic-Acid fortified breads and cereals – decreased neural tube defects
  • Probiotics – decreased risk of infections, lactose intolerance, diarrhea

DISCUSSION:

According to Marion Nestle, author of Unsavory Truths, and Food Politics – Paulette Goddard Professor of Nutrition, Food Studies, and Public Health, emerita, at New York University, Visiting Professor of Nutritional Sciences at Cornell:

“I wrote extensively about the paucity of evidence for the value of dietary supplements for anyone who eats enough of a reasonably varied diet. The supplement industry funds many studies that demonstrate health benefits from taking one supplement or another, but studies funded independently usually do not – and sometimes suggest that taking nutrients in pill form can be harmful.”

Don’t be fooled by the claims made by the purveyors of dietary supplements – In my opinion, most are more than likely no better than the remedies peddled by our ancestors, i.e., the snake oil salesmen. Lately some supplements have become very expensive (my opinion) and the consumer has the right to know whether to spend hard earned money on these products or not. To put it simply – Buyer Beware,

 

The Myths and Realities of Dietary Supplements

Dietary Supplements: The Myths and Realities

In 1994 Congress passed the Dietary Supplement Health and Education Act, which led to an explosion of manufactured compounds which are now number to more than 80,000 products on the market and the number continues to grow. Types of dietary supplements include:

  • Vitamins and minerals (Vitamin C and E, selenium)
  • Herbs (botanicals such as ginseng, ginkgo)
  • Proteins and amino acids (chondroitin sulfate, creatine)
  • Hormones, hormone precursors (DHEA, vitamin D)
  • Fats (fish oils, EPA, DHA)
  • Other Plant extracts (garlic capsules, fiber, echinacea, green tea)

A recent edition of Consumer Reports (December 2019) has provided a very comprehensive article by Kevin Loria entitled “Shop Smarter About Supplements”  that everyone should read if you take any dietary supplements to fully understand why consumers should be aware of the realities, both positive and negative of these products. Americans place lot of trust in diet supplement safety even though they are largely unregulated.

Here are some FACTS: Source: Consumer Reports

  • Percentage of Americans who take a supplement at least once a week: 68%
  • Percentage of Americans who take a supplement once a day: 54%
  • Percentage of Americans who say “supplements are safe”: 71%
  • Percentage of Americans who think supplements are tested by the Food and Drug Administration (FDA): 48%
  • Percentage of Americans who think the term “natural” means a supplement is safe or wholesome: 33%
  • Percentage of Americans who think supplements are safer than Rx or over-the-counter drugs: 38%
  • Percentage of Americans who think supplements usually work as well as Rx drugs: 32%

However, under the Dietary Supplement Health and Education Act, diet supplements do not have to be tested prior to marketing or shown to be safe or effective. Although they are often advertised to relieve certain ailments, they are not considered to be drugs. They are not subjected to vigorous testing to prove safety or effectiveness, as drugs must be. The FDA largely relies on any claims from the manufacturers.  It has been shown that many industry-funded studies only favor positive results and many negative effects never see the light of day. So when you read in a headline for a supplement, “clinical trials have shown…,” the bias of the manufacturer of the study results may be suspected.

In fact, each supplement label must include the following declaration of any claim:

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

To summarize the realities:

  • FDA does not approve, test, or regulate the manufacture or sale of dietary supplements.
  • The FDA has limited power to keep potentially harmful dietary supplements off the market.
  • Dietary supplements often do not list side effects, warnings, or drug or food interactions on product labels.
  • Ingredients list on dietary supplement labels may not include all active ingredients.
  • Dietary supplements may not relieve problems or promote health and performance as advertised.
  • Many products may remain on the market because “there’s a strong placebo effect.”
  • “People will feel better if they think they’re going to feel better.”

What Can You Do?

  • Purchase supplements labeled  USP (U.S. Pharmacopeia) and Consumer Laboratories (CL). They are tested for purity, ingredients and dose but does not address product safety of effectiveness directly.
  • Terms such as release assured, laboratory tested, quality tested, and scientifically blended on supplement labels guarantee nothing.
  • Check expiration dates on supplements.
  • Choose supplements containing 100% of the Daily Value or less.
  • Take supplements with meals.
  • Avoid calcium supplements made from oyster shells, bone or coral calcium. They may contain lead or aluminum.
  • Store supplements where small children cannot get at them. A high incidence of trips to the ER involve overdosing of a certain supplement by young children. Taking a large dose of iron can be life-threatening that can damage the intestinal lining and and may cause liver damage.
  • Tell your health provider about the supplements you take.  Consult your provider about health problems before you start taking supplements to try to treat health problems with herbal supplements.

Source: Judith E. Brown, Nutrition Now, 7th Edition.