Tag Archives: dietary supplements

Dietary Supplement Guidelines

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by Dr. Cathy Rosenbaum, Rx Integrative Solutions                                                       

Holistic Clinical Pharmacist

Certified Health Coach

Certified Fitness Nutrition Coach

SUPPLEMENT DEFINITION

A dietary supplement is a vitamin; a mineral; an herb or other botanical; an amino acid; or a concentrate, metabolite, constituent, extract, or combination of any of the above ingredients.

SUPPLEMENT QUALITY                                                                      

The FDA is not authorized to approve dietary supplements for safety and effectiveness. Most dietary supplements can be marketed without notifying the FDA (DSHEA Act 1994).  To ensure supplement potency and purity, look for proof of independent third-party analytical testing on supplement bottle labels (e.g., see the round quality seals):

  • consumerlab.com
  • NSF (National Sanitation Foundation) nsf.org
  • USP-Verified (U.S. Pharmacopoeia) usp.org
  • c-GMP (Good Manufacturing Practice – minimum required by FDA for all dietary supplements)
  • Certificate of Analysis (see store’s website, requested from the supplement’s manufacturer)

 CLINICAL RESEARCH (SUPPLEMENT INDICATION)

Look for research studies in humans with your same condition/health goal, identifying the exact product, dosing, and length of therapy BEFORE you purchase any dietary supplements

  • Visit clinicaltrials.gov (NIH sponsored website for all types of research)
  • Do not be misled by marketing hype/confusing supplement claims by famous people
  • Follow your doctor’s recommendations on the use of dietary supplements is using the latter instead of prescription medications for your health needs – discuss risk/benefits with your pharmacist (e.g., prescription statins vs red yeast rice for cholesterol lowering)

 SUPPLEMENT SAFETY/SIDE EFFECTS

  • Work with your pharmacist to manage unwanted effects and/or drug/supplement interactions
  • Write to FDA for Freedom of Information post-marking reports on supplement side effects
  • Report any unwanted supplement effects to your physician, pharmacist, or directly to the FDA via MedWatch https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
  • Do not take both dietary supplements and prescription medications for the same indication unless directed by your physician (e.g., diabetes mellitus, high cholesterol, high blood pressure)

SUPPLEMENT LABEL

  • Carefully read all the instructions for supplement usage, supplement facts, active and inactive ingredient list, and warnings, remembering dietary supplements are regulated by FDA CSFAN as nutrition (not medication) and contain ‘nutritional labels’ (e.g., serving size, not ‘dosing’ like OTC medications)

PROPRIETARY BLEND

  • Avoid dietary supplements with ‘proprietary blends’ when manufacturers do not disclose the actual amounts of every active ingredient (amounts considered to be a trade secret)
  • Note the proprietary blends are found in multivitamins, supplements for colds/flu, weight loss, body-building protein formulations, and many more
  • GLUTEN FREE SUPPLEMENTS
  • Prescription and OTC medications are not covered under the FDA’s gluten-free labeling rule whereas dietary supplements are covered. Any foods or supplements that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. For more information, visit the following websites:

*            www.glutenfreedrugs.com 

*            www.dailymed.nlm.nih.gov 

*            www.celiac.com 

ROLE OF THE HOLISTIC CLINICAL PHARMACIST

  • Feel free to consult with your holistic clinical pharmacist as an equal partner on your decision-making team to determine which dietary supplements are appropriate for your individual health goals, health conditions, lifestyle choices, and your value system.

 

 

Probiotic Dietary Supplement Safety & Efficacy Is in Question

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Probiotic dietary supplements have become quite popular in recent years, touted for such conditions as general health (prevention), immune health (prevention), leaky gut, diabetes mellitus, and dysbiosis from antibiotic overuse, among others.

Probiotics are generally safe for a heathy person (Generally Recognized as Safe [GRAS] per the FDA classification).  However, some live  probiotic strains may negatively play on a weakened immune system in at-risk persons,  allowing unwanted organisms to enter the body and cause pneumonia, endocarditis, or sepsis.  Probiotic supplements are not for everyone!

Activia yogurt, Yakuit yogurt, Dannon Probiotic yogurt, kefir, kimchi, sauerkraut, tempeh, miso, and kombucha are examples of food sourced-probiotics. Culturelle and Align are popular probiotic dietary supplements. Florastor is a prescription medication.  Examples of probiotic strains include, but are not limited to, bacteria (e.g. Lactobacillus, Lactococcus, Leuconostoc, Pediococcus, Bifidobacterium, Bacillus) and yeast (e.g., Saccharomyces).

It’s important to choose the right probiotic product for your health needs with the help of your pharmacist, who can thoroughly evaluate the product  before recommending it to you.  Product criteria:

  • strain identification by genome sequencing
  • transmissible antibiotic resistant gene profile
  • toxicology in vitro and in vivo studies
  • clinical studies on efficacy (how well does the product work)
  • target population (healthy  vs sick)
  • product formulation and labeling (product purity, contaminants)

If probiotic manufacturers claim to treat/prevent disease, their probiotics should be studied and marketed as drugs, rather than as  supplements, upholding FDA regulation.  Probiotics are not drugs, not magic bullets, nor are they universally safe and effective.

The appropriate probiotic strain and formulation should be recommended by your healthcare professional based on your individual health needs.

For more information or to schedule an integrative health and wellness consultation with Dr. Cathy Rosenbaum,  holistic clinical pharmacist, Certified Health Coach, Certified Dementia Practitioner, and Tai Chi Easy Practice Leader in Blue Ash OH,  please visit www.rxintegrativesolutions.com.

–Dr. Cathy Rosenbaum

 

 

 

Kothari.  Probiotic supplements might not be universally-effective and safe: A review.  Biomed Pharmacother 2019;111:537-547.

Finding Gluten-Free Nutrition, Dietary Supplements, and Medications

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Non-celiac gluten intolerance and celiac disease are becoming more common. Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten. Non-celiac gluten intolerance is diagnosed in people who do not have celiac disease, but have intestinal or extra-intestinal symptoms related to ingestion of gluten-containing grains.

Both conditions are treated by avoiding gluten containing foods. Finding ‘gluten free’ nutrition is becoming easier to do, but eliminating gluten from one’s diet can be a complex and time-consuming process.

Gluten is the protein component of wheat (e.g., including spelt, kamut, semolina, and triticale), barley (e.g., including malt), and rye. When a person with celiac disease or non-celiac intolerance ingests gluten, specifically the antigenic gluten constituent called gliadin, it can cause intestinal inflammation, diarrhea, abdominal pain, bloating, weight loss, fatigue, and iron deficiency anemia. Food malabsorption and nutritional deficiencies result.

Over time, these conditions can cause liver disease, defective gallbladder emptying, and osteoporosis. Celiac disease may be a reversible cause of osteoporosis. Adherence to a gluten-free diet is one way to help suffers minimize overall symptoms and to maintain maximal bone mineral density.

For perspective, oats are considered a type of gluten grain, but do not have the antigen that other gluten grains above do. Thus, oats do not induce an immune reaction in the small intestine of people with celiac disease. However, many commercial oat products are contaminated with wheat, barley, or rye and it’s important to carefully read their labels. Look for products that are certified to contain less than 20 ppm of gluten (FDA’s ‘gluten free’ definition).

Consumption of as little as 10 mg-50 mg gluten daily can lead to a clinical relapse in people with these conditions. Celiac disease may increase the risk of developing some types of cancer (e.g., T cell lymphoma and intestinal adenocarcinoma) if gluten restrictions are not maintained or gluten intake is only partly restricted.

It is important to find out where gluten resides in foods. This means not only reading food labels on products you purchase for home but also on foods you consume from fast food establishments and restaurant dining. Soups, sausages, and ice cream may contain hidden amounts of gluten as fillers. Talk with your grocer and restaurant owners before you consume questionable food items.

Watch out for the gluten content in herbs, other dietary supplements, and medications.

Gluten-Free Foods
Consuming foods certified to be ‘gluten free’ will help keep the daily gluten total to under 50 mg and not cause symptoms for most people with celiac disease. Gluten-free grains include rice, millet, corn, quinoa, sorghum, and buckwheat. For more information, visit http://glutenfreecooking.about.com/od/gettingstarted/a/hiddengluten.htm
or http://www.glutenfreeliving.com/nutrition/ingredients.

Gluten-Free Herbs and Other Dietary Supplements
It would be impossible to find information about the gluten content in over 60,000 products on the worldwide market. One can contact dietary supplement manufacturers directly for more information on gluten content before taking any of these products, including vitamins.

Gluten-Free Medications
Over-the-counter and prescription medications may contain gluten in the list of inactive ingredients. For example, sweeteners used in medications may be hidden sources of gluten. Some manufacturers cannot guarantee their medications are gluten-free because the suppliers of raw materials can not do so, making it even more difficult for consumers to figure out what is safe to take and what is not.

A great resource for determining the overall ingredient content in medications, including whether or not gluten is present, can be found online at www.glutenfreedrugs.com .

Another online medication reference comes from the National Institutes of Health at www.dailymed.nlm.nih.gov. Go to the site, type in the generic name of the medication you want to review, then scroll down to the name of the manufacturer of that particular product, then click on ‘description.’ Scroll down to the inactive ingredients and look for gluten.

A third way to find more information about your medication’s gluten content is to call the medication manufacturer directly. Be sure to have the medication’s lot number available when you call.

Finally, click on https://www.ncbi.nlm.nih.gov/pubmed/?term=Gluten+content+of+the+top+200+medications+of+2009%3A+a+follow+up+to+the+influence+of+gluten+on+a+patient%E2%80%99s+medication+choices for “Gluten content of the top 200 medications: follow up to the influence of gluten on a patient’s medication choices” by AR King in Hosp Pharm 2013:48:736-43.

By Cathy Rosenbaum PharmD MBA RPh CHC

Grapefruit Interactions with Medication

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Certain prescription and/or OTC medications and dietary supplements may negatively interact with grapefruit juice, grapefruit, Seville oranges, pomelos, and tangelos due to chemicals in the fruits.

Fruit chemicals are thought to block enzymes in the body that metabolize medication in the small intestine, thereby causing the medication to hang around longer than expected. Interestingly, these fruits may also interfere with transporters in the body, causing medication to be less well absorbed into the bloodstream, and may reduce medication or supplement effects. Sound confusing? It’s complicated.

Product classes involved in unwanted interactions include, but are not limited to:

-Antihistamines (e.g., Allegra)
-Antianxiety
-Antihypertensives
-Cholesterol-lowering ‘statins’
-Corticosteroids for Crohn’s disease and ulcerative colitis
–Dietary supplements

Only some of the medications and supplements in each of the categories can be affected by the fruit/juices. Every person may react differently based on the amount of fruit they consume, the medication or supplement type/dose taken, and the individual’s natural ‘enzyme levels.’

Don’t worry, but do get educated about how and when to properly take your medications and supplements to be safe. Enjoy healthy nutrition. Talk with your pharmacist about what’s best for you!

Beyond Use Dates on Prescription/OTC Medications & Dietary Supplements

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Expiration dates on OTC & prescription medications and dietary supplements typically fall between 12 – 60 months after product production. Pharmaceutical manufacturers are required by law to establish these dates but do not have to study product stability and potency beyond those dates.

A recent study published in JAMA Internal Medicine using eight medications containing 15 active ingredients demonstrated product potency for decades beyond the original expiration dates. Another study in the military concluded the same results for 100 medications after 15 years.

The U. S. government has a Shelf Life Extension Program to extend dates on federal stockpiles for the military. But this is the exception to the rule in a special population to save the government money in repurchasing.

The bottom line for consumers is this – > follow the product manufacturer’s established expiration date stamped on the OTC bottle or prescription vial. Follow these same guidelines for your dietary supplements as well.

Keep all of these products in a cool, dry, dark place in your home.

The Alpha and Omega of Omega 3 Fatty Acids

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Growth in the dietary supplement category over the past few years has skyrocketed with over 60,000 products available to consumers worldwide. A dietary supplement is a product that contains an ingredient intended to add further nutritional value to (i.e., to supplement) the diet, and may be one or more of the following:
• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a concentrate, tincture, or extract

In the U.S.A., the major regulatory driver within this product category has been the Dietary Supplement Health Education Act (DSHEA) of 1994. Under this Act, supplements are presumed to be safe and do not need FDA approval before they are marketed. Supplements are regulated by the FDA as food under the Center for Safe Food and Nutrition (CSFAN), and bear a nutrition label. However, supplements are used by many like medications to treat medical conditions, and as such may have side effects and interactions that need to be managed. With regard to prevention, supplements are not a replacement for good nutrition or a healthy lifestyle including restorative sleep, exercise, emotional, social, and spiritual wisdom (Proverbs 3:1-8).

According to a survey by Bailey, et al. (JAMA Intern Med 2013;173:355), polls showed people used supplements to improve their health, to improve bone density, to lower total cholesterol levels, boost immunity, or manage joint pain from osteoarthritis. Respondents reported they took multiple vitamins, calcium, and fish oil most often, without the recommendation of a health care professional. That practice may be unsafe!

Anti-Inflammatory Fish Oil Supplements
The USDA’s 2013 Dietary Guidelines for Americans recommend that adults keep daily fat intake to a maximum of 20%-35% of total calories. Most of this fat should come from mono- and polyunsaturated fats (i.e., fish, nuts, vegetable oils).

Omega 6 and omega 3 are two essential (polyunsaturated) fatty acids (EFAs) that we must obtain from our diet. At this time, clinical studies supporting any omega 3 health benefits are inconclusive, with the exception of prescription strength Lovaza (omega 3) which is FDA approved for lowering very high triglyceride levels.

The typical American diet is rich in omega 6 essential fatty acids and lacking in omega 3 essential fatty acids. However, many foods contain both. There are three main omega 3 constituents in nature, namely eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). ALA is a precursor to EPA and DHA. Our body does not metabolize ALA into EPA and DHA very well.

Foods rich in omega 6 essential fatty acids in order of decreasing content include sunflower oil, corn oil, wheat germ oil, safflower margarine, sesame oil, walnuts, avocado oil, almond oil, peanuts, peanut butter, and palm oil.

Foods rich in various types of omega 3 essential fatty acids in order of decreasing content include salmon oil, sardine oil, cod liver oil, canola oil, herring, shrimp, krill oil, flaxseed oil, and walnuts (ALA).

When purchasing fish oil-based products, make sure you check with the manufacturer to ensure they have been tested for mercury, polychlorinated biphenyls (PCBs), and other unwanted contaminants. This kind of information rarely appears on the label.

Check to see how much EPA and DHA are in that 1,000 mg dose of fish oil to assess product value before purchase. You should look for EPA and DHA as your active ingredients! If the amount of EPA plus DHA combined is 30% or less of the total dose (i.e. 300 mg in a 1,000 mg capsule) you are not getting the quality you desire for your money. Most of the rest of that dose is typically composed of omega 6 fatty acids or omega 3’s we cannot metabolize (i.e. ALA).

There are no established dietary reference intake (DRI) standards for DHA or EPA daily consumption. The Institute of Medicine suggests an intake of 160 milligrams of DHA and EPA combined each day. The American Heart Association recommends eating fatty fish at least two times each week, which is equal to about 1,250 mg DHA and EPA each day.

The European Food Safety Agency recommends 250 mg/day EPA and DHA combined for adults or 1-2 servings/week of oily fish. The World Health Organization recommends 1-2 servings of oily fish/week providing 200 mg – 500 mg/serving of EPA and DHA for the general population to prevent ischemic stroke and coronary heart disease.

Pregnant women require 200 mg of DHA daily to support fetal development. The Environmental Protection Agency advises women of childbearing age, nursing moms, and young children to consume only 2 servings per week of sardines or salmon and avoid tuna due to the methyl mercury content.

There are three grades of fish oil on the market, namely cod liver oil, health food grade fish oil, and pharmaceutical grade fish oil. Look for pharmaceutical grade omega 3 fatty acids as the highest quality of these three.

In general, please know that the dose of omega 3 that’s right for you may not be appropriate for others and could differ for diabetics and people with heart disease due to potential side effects. Talk with your physician and pharmacist about what’s best for your health needs before you purchase any dietary supplements.

By Cathy Rosenbaum PharmD MBA RPh, Rx Integrative Solutions