Nutritional supplements remain one of the most popular integrative medicine treatment modalities used throughout the United States. Adult cancer survivors alone spend approximately $6.7 billion on vitamins/minerals each year, whereas the general public averages $12.8 billion on natural product supplements and $2.7 billion on self-care products. According to the American Botanical Council, “herbal” sales totaled $7.0 billion in 2015, a new record. The industry has a complex history and the medical acceptance of supplements is even more complicated. With supplements being imported, manufactured, marketed and sold in a wide range of products through a variety of media and sales outlets, it’s challenging to keep pace with the potential benefits of the tried and true and the dangers of infomercial night-owls. When my patients and colleagues ask me if Nutritional/Dietary Supplements are safe my answer is, “generally yes but…” The goal of the following discussion is to make us all better, wiser and safer consumers of Nutritional Supplements (NS) so we can take full advantage of the health benefits while minimizing the potential for unwanted side effects and loss of time and money.
What’s in a name & government oversight:
The term Nutritional or Dietary Supplement was brought in to the mainstream by the “Dietary Supplement Health Education Act” (DSHEA), which was sponsored by Senator Orin Hatch from Utah in 1994. The key aspects of DSHEA define a nutritional supplement as a product:
- Intended to supplement the diet
- Containing one or more dietary ingredients (vitamins, minerals, herbs or other botanicals, plant or part of a plant used for its flavor, scent, or potential therapeutic properties and may include flowers, leaves, bark, fruit, seeds, stems, and roots, amino acids, and certain other substances) or their constituents
- Intended to be taken by mouth, in forms such as tablet, capsule, powder or liquid
- Labeled as being a supplement.
There is considerable confusion in regards to regulation, industry oversight and the transition between food and highly extracted and concentrated, “drug-like” supplements. Under DSHEA the Food and Drug Administration (FDA) regulates supplements as food and its primary methods of enforcement include inspections of facilities and ensuring that manufacturers follow good manufacturing (GMP) practices. The Federal Trade Commission (FTC) provides oversight of label claims and false advertising. The natural products industry is largely “self-regulated” and its goal is the manufacture and sale of safe products that support health and wellness, not to have unrepeatable companies fined for misguided practices.
Both FDA and FTC weigh in on the validity of label claims which must not be false or misleading, and must be based upon reliable scientific evidence and clinical studies (when available). It should be noted that both FDA and FTC as well as case law allows and protects “key ingredient claims” which are based on efficacy testing of key product ingredients as opposed to requiring testing of the full multi-ingredient finished product. So keep this in mind when comparing products and choose based on the most appropriate supplement, at the best dose and formulation for the clinical indication. Avoid supplements that add “window dressing”, or small amounts of an ingredient for marketing purposes but not enough to make a clinical or health impact.
The Gold Standard
In addition to, “what individual or specific supplement should I be taking to support or improve my specific condition”, the most common question I get from patients is “how can I ensure that the supplements I’m buying are safe and of the best quality?” My ultimate test is to be an educated consumer and ask for verification (a copy of the report results) of the quality control testing for the specific products or “lot“ you are using and/ or want to purchase. Many of the supplement raw materials are imported from companies that grow and process individual ingredients outside the United States. These companies provide a certificate of analysis (COA), or stamp of authenticity that says you can trust me, “We grew, processed and tested the material and it is free of any contaminants.” The FDA requirements mandate that testing is required for product: authenticity, potency, microbiology and stability. Often the only thing separating the finished and bottled product is the recipe, dose and the degree of testing completed by the local US companies. You should be assured that products are free of heavy metals, chemical solvents, pesticides, PCBs, aflatoxins, fungicides and that oils are not rancid.
All reputable companies and manufacturers conduct comprehensive quality control (Q/C) testing on the individual ingredients and the finished products of each lot they use. If you and or your health care team ask for the Q/C testing and it shows up, this is a good indication that you have a quality product form a reputable company. If it doesn’t then it’s your choice to trust them. Use a reputable company that provides this information and one that does not conduct “skip lot testing” or merely relies on the vendors COA. You want to be assured that the curcumin (Curcuma Longa, Turmeric spice) you’re taking to provide a mild anti-inflammatory effect indeed is 500mg of rhizome extract and contains 85-90% curcuminoids as opposed to yellow pigmented, processed saw dust.
Categories to Avoid:
A majority of potentially harmful supplements fall into 3 categories: weight loss, sexual enhancement and sports/stimulants. So the good news if you avoid these classes you’ll greatly reduce the likelihood of taking an unknown drug (which has been added to the supplement for some extra kick) or having a drug/drug or drug/herb interaction. Regular FDA alerts on fraudulent and adulterated or contaminated supplements can be found at the fda.gov/ website designed to help consumers buy and use medicine safely. If the marketing sounds like it’s too good to be true and if you are watching the trailer at 2am or on the web, then it probably is!
To put this into perspective, every year there are well over 100 notifications and or recalls of potentially dangerous supplements, included the following selected products marketed for:
- 1. Sexual enhancement: Triple Green Capsules (contained Viagra), Big Penis Male Sexual Stimulant (contained Viagra), Black Mamba (contained Viagra), African Viagra (contained Viagra), Duramaxxx (contained Viagra), and My Steel Woody (contained Viagra).
- 2. Weight loss: Queen Slimming Soft Gel (contained fluoxetine and sibutramine), Skinny Bee Diet (contained desmethylsibutramine), ABX Weight Loss (contained sibutramine), Ultimate Lean (contained sibutramine), Dream Body Extreme Gold, (contained sibutramine, fluoxetine and sildenafil) and
- 3. Sports /fitness: one company alone, BODYBUILDING.COM, conducted a voluntary nationwide and international recall of 65 supplements because they may contain steroids marketed as “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol. Use a common sense approach by avoiding these categories and focusing on maintaining healthy diet, stress reduction, proper sleep, exercise and good relationships.
- Manage your expectations.
- Don’t look for quick fixes.
- If it sounds too good to be true…
- You want products that are legal.
- Look for nationally recognized brands or store brands from a trusted retailer.
- Look for quality seals or third-party certifications.
- Look for membership in an industry trade association.
- Visit the company’s website.
- Look for product labels and ingredient lists.
- Be careful of companies that regularly undergo name changes.
Clinical Applications:
Recent research suggests that safely utilizing dietary supplements in 4 major areas (coronary artery disease, diabetes, age-related eye disease and osteoporosis) with 10 ingredients could hypothetically reduce medical costs by over $50 billion in the US in the period of 2013-2020. Information changes rapidly. Whenever possible engage in straight forward discussions with your physician and entire health care team and review all supplements regularly. Five years ago hardly anyone knew their vitamin D blood levels. Today it’s common to determine D levels and adjust the dosage, seasonally or when medically necessary. If appropriate to your health care plan, test nutrient levels (B12, folate, homocysteine, DHEA, Iron, pregnenalone, zinc, magnesium, calcium, CoQ-10), before taking new supplements or considering a major dose adjustment. Also, as the number of prescription drugs used increases with age, consider the potential for Herb/Drug and Herb/Herb interactions such as induction or inhibition of Cytochrome P450 enzymes or “CYPs.” The goal is to use supplements to help prevent future health problems. Next to avoiding the “troublesome three” categories mentioned above, testing levels and determining interactions are additional steps to ensure you are maximizing supplementation and minimizing unwanted effects.
In summary, with the popularity, demand and continued growth of the supplement industry, be an educated, safe consumer and use common sense when selecting and dosing. Discuss all items with your healthcare team (family, physicians, physician assistants, nurses, pharmacists, and Integrative medicine providers). Choose supplements on the most appropriate ingredients for your indication and always choose from reputable companies who meet the regulatory requirements and are willing to provide quality control testing information. I’ll leave you with “tips” the Council for Responsible Nutrition provides to all consumers:
Submitted by Eric R. Secor, Jr ND, PhD, MPH, MS, LAc, Dipl. Ac.
Dr. Secor is currently the Associate Medical Director of Integrative Medicine within the Hartford Healthcare Cancer Institute. Eric grew up in the Farmington Valley working in restaurants and health clubs where his interests in wellness and prevention began. His NIH postdoctoral research (Pulmonary Immunology with Dr. Roger Thrall, UConn) investigated natural products such as Bromelain, a pineapple extract and established its role in treating allergic asthma and modulating the cellular mechanisms of allergic sensitization. In addition to clinical care, research and administrative duties, Eric enjoys lecturing for patient groups, medical professionals and consults for the NIH on educational and research grants focused in Integrative Medicine. He lives in the Farmington Valley with his wife, Dr. Mary Markow, two girls, cats a dog and some fish. Visit: https://hartfordhospital.org/EricSecor.