NUTRITION for a Changing World Jamie Pope, Steven Nizielski, and Alison McCook NUTRITION for a Changing World FIRST EDITION Chapter 12 Dietary Supplements Supplements, Herbs, and Functional Food © 2016 by W. H. Freeman and Company & Scientific American

Chapter 12 Objectives Identify at least three situations or conditions for which specific supplementation may be warranted Provide an overview of the regulatory policies in the United States for dietary supplements compared with those for prescription or conventional drugs Describe the types of information provided on the “Supplement Facts” panel Describe how approved health claims differ from structure/function claims for dietary supplements, and provide at least two examples of each Provide an example of an herbal supplement, and explain its possible benefits and adverse effects Describe what might make a food “functional,” and how these types of foods might affect health, dietary quality, and overall nutrient intake Characterize the difference between probiotics and prebiotics, and give examples of each

Surprising Studies on the Value of Vitamin Supplements Professor Gilbert Omenn conducted the Beta-Carotene and Retinol Efficacy Trial (CARET) Beta-carotene and vitamin A supplement was increasing participants’ risk of lung cancer Trial stopped

What Are Dietary Supplements? Food or substance that supplements the diet and contains one or more dietary ingredients or their constituents Vitamins, minerals, herbs, other botanicals, amino acids, or enzymes Form Pill, capsule, tablet, liquid, powder, and bar

Who Benefits from Taking Supplements? Infants and children (vitamin D) Women who may become pregnant (folic acid) Pregnant women (folic acid and multivitamin) Vegans (vitamin B12, calcium, iron, and zinc) Those who do not consume dairy products (vitamin D and calcium) Adults older than 50 years (vitamins B12 and D)

Who Benefits from Taking Supplements? Those with dark skin (vitamin D) Individuals on restricted diets (multivitamin) Smokers, alcohol-dependent individuals, and those taking some medications (multivitamin) Women who are pregnant; women with heavy menstrual periods (iron) Individuals who frequently donate blood, as well as those with stomach and intestinal conditions (iron)

Dietary Supplements Regulated by a 1994 Dietary Supplement Health and Education Act (DSHEA) The manufacturer is responsible for ensuring that the product is safe, unadulterated, produced with good manufacturing practices, and properly and truthfully marked with a label Dietary ingredients have to be federally regulated and GRAS (generally recognized as safe) The FDA does not approve dietary supplements for their effectiveness or safety, nor does the FDA regulate dietary supplements as rigorously as it does drugs. Ingredients or additives that were already in the food supply prior to when DSHEA went into effect were grandfathered in as GRAS, so they don’t need FDA approval before being marketed.

Dietary Supplements 2011 Food Safety Modernization Act Expands FDA authority over new dietary ingredients Has not been fully implemented DSHEA requires that manufacturers notify the FDA 75 days before new dietary ingredients/products are introduced, and they must provide the agency with evidence that the supplement is “reasonably expected to be safe” at the labeled dosage. Unfortunately, it is common for supplement distributers and manufacturers to ignore this and other regulations. Supplements are sometimes sold with contaminated or banned substances or prescription drugs. The FDA is responsible for taking action against unsafe or improperly labeled dietary supplements after they go to market, but this is not easy to do. The FDA must prove that the product is unsafe in order to restrict its use or remove it.

Dietary Supplements Current Regulations Proposed Regulations Manufacturers must submit to the FDA information regarding the “safety and efficacy” of a dietary supplement containing a new ingredient The manufacturer needs only to demonstrate that the new dietary ingredient can “reasonably be expected to be safe” by providing some evidence of safety but not actually proving safety The FDA does not approve new dietary ingredients or supplements; they are free to be marketed 75 days after the information was submitted to the FDA Safety must be established by a documented history of use at the same or higher dosage, frequency, and duration of use Laboratory or animal studies would be required for products marketed for consumption at higher than historical intakes No human studies are required, even for substances without any documented historical use The company is not obligated to report results showing adverse effects; they need only to submit positive results supporting their claim of safety DSHEA requires that manufacturers notify the FDA 75 days before new dietary ingredients/products are introduced, and they must provide the agency with evidence that the supplement is “reasonably expected to be safe” at the labeled dosage. Unfortunately, it is common for supplement distributers and manufacturers to ignore this and other regulations. Supplements are sometimes sold with contaminated or banned substances or prescription drugs. The FDA is responsible for taking action against unsafe or improperly labeled dietary supplements after they go to market, but this is not easy to do. The FDA must prove that the product is unsafe in order to restrict its use or remove it.

Dietary Supplement Labels General information Name of the product Word “supplement” Quantity Manufacturer name and location Direction for using the product “Supplement Facts” panel Serving size Percent daily value (DV) Dietary ingredients Nondietary components May include cautionary statements about potential side effects Substances and ingredients that do not have recommendations are allowed on the supplements panel. Unlike drugs, supplements manufacturers do not have to list known adverse effects on their label.

Dietary Supplement Labels Health claims Must be FDA approved based on the Significant Scientific Agreement (SSA) Selected approved health claims For example, “Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord defect.” Supplements may include health claims that describe a relationship between a dietary supplement ingredient and a reduced risk of a disease or condition. The FDA must preapprove these claims based on the Significant Scientific Agreement (SSA).

Dietary Supplement Labels Qualified health claims FDA approved Emerging evidence Selected qualified health claims For example, “Vitamin C may reduce the risk of gastric cancer. The FDA has concluded that there is very little scientific evidence for this claim.” The FDA also allows qualified health claims for conventional foods and dietary supplements when the evidence linking a food, food component, or supplement to reduced risk of a disease is emerging but not well enough established to meet the SSA standard for a true health claim.

Dietary Supplement Labels Structure/function claims Mandatory disclaimer

Supplement Quality FDA does not monitor quality, potency, purity, or efficacy Supplement manufacturers required to report serious harmful effects to the FDA FDA does not regulate terms “Pure” “Natural” “Quality assured” Supplements are not monitored for quality assurance, potency, purity, or efficacy. The FDA does track reports of illness, injury, or reactions that might occur in consumers after taking supplements.

Supplement Quality Independent labs test supplements United States Pharmacopeia Convention (USP) set standards and provides seals of quality Labs do product reviews NSF International (NSF) ConsumerLab.com (CL) Manufacturers can voluntarily submit products for testing. The USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements distributed worldwide and provides seals of quality that companies can display on their products. Other labs do product reviews.

Are Supplements Harmful?

Tips for Choosing a Multivitamin Supplement Read the label carefully Look for quality products Look for the expiration date Consider formulas for men, women, and age groups Do not overdo it

Herbal Supplements Includes plants (botanicals) Usually consist of dried preparations of flowers, leaves, roots, bark, and/or seeds Herbs are less potent crude drugs and can have druglike effects but do not undergo the same stringent approval process as drugs do. They may have other biological active ingredients or toxins in addition to their active or “useful” components. Even though they are natural, they can cause drug interactions and exacerbate medical conditions.

Functional Foods Nutraceuticals Health benefits No statutory legal definition

Functional Foods

Functional Foods Probiotics = bacteria in the gut that may have many possible health benefits Prebiotics = nondigestible carbohydrates that promote growth of beneficial bacteria in our gut

Functional Foods

Let the Supplements Buyer Beware Supplements are important for some individuals but not tightly regulated Potential effects may not be understood Weigh benefits versus risks

Summary Dietary supplements, including vitamins, minerals, herbs, botanicals, amino acids, and enzymes, are meant to “supplement” the diet, not replace nutrients that are best obtained through a varied and balanced diet Under the 1994 Dietary Supplement Health and Education Act and more recently the 2011 Food Safety Modernization Act, the United States Food and Drug Administration (FDA) is responsible for regulating the safe labeling and manufacturing of dietary supplements, as well as approving any health claims made for the supplements Manufacturers are also able to make certain claims about how a product affects the body’s structure or function; these structure/function claims must include a disclaimer that the claim has not been evaluated by the FDA

Summary (Cont’d) Current evidence does not demonstrate that supplements provide significant health benefits; they may, in some cases, increase the risk of disease and mortality, however, there are some individuals and groups that may benefit from using supplemental nutrients to help meet their nutritional needs Current regulations do not require dietary supplements, including botanical supplements, to undergo the same rigorous testing for effectiveness, interaction, or safety requirements as conventional drugs Supplement manufacturers are responsible for ensuring that supplements are safe, unadulterated, and produced with good manufacturing practices Manufacturers must provide specific product information and ingredients on the “Supplement Facts” panel

Summary (Cont’d) Supplements may also include health claims on the label that describe a relationship between a dietary supplement ingredient and a reduced risk of a disease or condition; these claims must be preapproved for use on the supplement labels by the FDA, using the Significant Scientific Agreement (SSA) The use of high-potency supplements may result in nutrient intakes above the tolerable upper intake level and cause adverse effects Some foods may have a positive effect on health beyond that of basic nutrition; these are called functional foods, and the group includes whole foods as well as fortified food products