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Food Additivies/Dietary Supplements Are They Safe and Effective? How Do We Know? Mike Mangino Food Science & Technology - OSU August 5, 2008 Mangino.firstname.lastname@example.org Additives What’s in food? Why is it there? How do we know its safe? Who decides if its safe? What is the difference between an additive and a supplement. What is the function of most food additives? Food Additive Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly in its becoming a component or otherwise affecting the characteristics of any food including any substance intended for use in producing, manufacturing, packaging, processing, preparing, treating, transporting or holding food. History Most of the law we now follow was enacted in 1958. Prior to that time the FDA had to prove that an additive was harmful before it could force its removal from food. The 1958 act shifted the burden of proof. Now industry has to prove that a substance is safe before it can be used in food. FDA Philosophy For something to be used a s a food or drug it must meet two criteria 1. It must be safe 2. If must be effective Supplements Food Ingredients Compared to Dietary Supplement Ingredients Foods - pre-market approval required, products with unapproved additives can be seized Dietary Supplements - no pre-market approval, includes many substances not legal to use in foods, harm must be demonstrated before seizing products GRAS Additive GRAS - Generally Recognized As Safe - originally included 675 substances GRAS review - each additive is reviewed by FASEB and additives that are still considered safe on the basis of the best experimental evidence are affirmed GRAS Affirmed GRAS Acetic acid Ferric chloride Whey Benzoic acid Garlic Caprylic acid Helium Lecithin Linoleic acid Maltodextrin Niacin Malic acid Rapeseed oil Salt Potassium acid tartrate Brown algae BHT Sucrose L-Cysteine Corn syrup Vitamin A. Wheat gluten Cyclamate Acute Toxicity These tests determine how toxic a single dose of an additive is to rats. The median lethal dose (LD50) is the amount of the compound that will kill half of the animals within two weeks after the dose is administered. Acute Toxicity Compound LD 50 154 lbs Salt 3.75 g/kg 9.28 oz BHT 3.20 g/kg 7.84 oz DDT 0.50 g/kg 1.25 oz Cyclamate 17.2 g/kg 42.4 oz Solanine 0.042 g/kg 0.11 oz Short Term Toxicity Normally in two species Duration = 90 days Determine Weight gain Food consumption Organ weights Complete blood profile Histopathological examination of organs Teratogenicity A teratogen is a compound that causes a miss-read in the DNA. This causes birth defects and is not an inheritable change. This often occurs in first few cell divisions after the egg is fertilized. These studies require the feeding of the compound prior to conception and then examination of the fetuses. Thalidomide Reproductive Studies Three generations of animals At least two litters per generation Observe Fertility Length of gestation Live births Still births Body weights Survival at 4 days Gross abnormalities Chronic Feeding Studies Two years in two species Control group and test groups. The highest dose level would generally be the highest dose that would not reduce the life span of the animals. These studies are conducted in parallel with the reproductive studies discussed before. These tests are used to determine the no effect dose. Also called the NO Effect Level ( NOEL) No Effect Level The concentration that shows no affect in the most sensitive species Human exposure can not exceed 1/100 the the no affect dose Does not apply to carcinogens Biochemical Determine fate of the compound in the animal. Absorption Distribution Storage Tissues accumulation Metabolism Enzyme profiles Mutagenicity Difficult to determine in intact animals Exposure of human leukocytes in culture Microbiological Treated and untreated animals mated and fetuses examined Delaney Clause Deals with carcinogens Cannot add any substance to food if it induces cancer when ingested by man or animal or if it is found, after tests which are appropriate for the evaluation of the safety of food additives to induce cancer in man or animals. Ames Test All carcinogens must be mutagens Not all mutagens are carcinogens Presumptive test Bruce Ames " I think that we got off on the wrong track. We're concentrating almost exclusively on little bits of pollution and man-made things and ignoring enormous amounts of natural mutagens and carcinogens. Many vegetables - including mushrooms, celery and parsnips, contain ‘natural pesticides’ made by plants to protect against insects. Those pesticides contain chemicals that are more significant carcinogens than man-made chemicals." Safety Considerations Conversion to toxic compounds Excretion in less toxic forms Evidence of non-adsorption Half-life and storage in tissue Synergism and antagonism Stress effect on different, sex, age and ethnic groups or disease states. Problems with Safety Impossible to determine absolute safety Can’t use human subjects Extrapolation from animals to humans Extrapolation from large to small doses Cost Safety of additive maybe greater than food Final decision comes down to judgment Acceptable Applications Improve nutritional value Enhance quality Reduce waste Improve storage quality Enhance acceptability Facilitate preparation Make food more available Unacceptable Applications To disguise inferior products To deceive the consumer To provide otherwise desirable results that lower the nutritional value To replace good manufacturing practices To use in amounts greater than are necessary Additives Listed on labels from most to least Most of the additives are related to taste or flavor (but flavor compounds may not be individually listed) Only a limited number of preservatives are used Most Common The most widely used additives based on weight of usage are: – Sucrose – High fructose corn syrup – Dextrose (Glucose) – Salt What do they have in common? The Dietary Supplement Phenomenon Big Business: $22.5 billion in sales in 2007 (NBJ website) Popular Products: 14% of individuals surveyed had taken herbal product/supplement during previous week Users: primarily self-initiated vs. practitioner-based 67% of regular supplement users would continue use even if FDA said products were not effective - ??? Source: NAS Report (2005) Dietary Supplements - 2001 Sales Breakdown Vitamins - $5.8 billion Minerals - $1.2 billion Herbs/Botanicals - $4.1 billion Sports Nutrition - $1.5 billion Others (incl. combination products) - $3.8 billion Definition of Essential Nutrient = A substance required for normal body functioning that cannot be synthesized by the body and must be obtained from a dietary source Vitamins and minerals (usually as enzyme co-factors in physiological reactions) Essential fatty acids (building blocks for fats) Essential amino acids (building blocks for proteins) Adulteration According to an FDA regulation: A food shall be deemed adulterated if it bears a poisonous or deleterious substance which may render it injurious to health, but in the case that the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health. Dietary Supplements Dietary supplements fit into this definition. The FDA tried to regulate them as a food if they were used as herbal products consumed like foods and as food additives or drugs if they were added to foods or sold in capsules and advertised with claims. Congress passed a law (see below) that stopped the FDA from enforcing their rules and established a new set of rules for supplements. FDA When the FDA tried to regulate supplements using the standard that is used for foods and drugs the industry objected and mounted a big advertising campaign. The FDA wanted two things from those who marketed supplements as cures for an illness. They wanted be assured that they were safe and they wanted some proof that they worked. I am biased but I think these are reasonable expectations. As a consumer I want the products I buy to be safe and I want them to do what they promise to do. After much lobbing by the supplement industry congress passed a law that essentially told the FDA to treat supplements as pure foods rather than as drugs are as additives. DSHEA (Dietary Supplement Health and Education Act – 1994) Assured American consumers access to products Defined dietary supplements Established regulatory framework • Food & Drug Administration (FDA) • As foods, not as drugs Established rules for what a label should contain Established ODS at NIH in the Office of the Director Definition of Dietary Supplement = A product intended to supplement the diet that bears or contains one or more of the following ingredients: A vitamin, mineral, amino acid, herb, other botanical; A dietary substance for use to supplement the diet by increasing the total dietary intake A concentrate, metabolite, constituent, extract, or combination of any ingredient describes above Intended for ingestion in the form of a capsule, powder, soft gel, or gel cap and not represented as a conventional food or as a sole item of a meal or diet Definition of Dietary Supplement (cont.) Structure/Function Claims May describe role of nutrient or dietary ingredient intended to affect a structure or function in humans Manufacturer is responsible for ensuring accuracy & truthfulness of these claims; since not approved by FDA, products must carry a disclaimer ―These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.‖ Claims requiring FDA approval Lowers cholesterol Maintains healthy lung function in smokers Provides relief of chronic constipation Suppresses appetite to treat obesity Supports the body's anti-viral capabilities Relief of persistent heartburn or acid indigestion Helps reduce difficulty in falling asleep Helps restore sexual vigor, potency and performance Claims that do not require FDA approval Helps maintain normal cholesterol levels Maintains healthy lung function Provides relief of occasional constipation Suppresses appetite to aid weight loss Supports the immune system Relief of occasional heartburn or acid indigestion For relief of occasional sleeplessness Arouses sexual desire Improves memory Improves strength Promote digestion Boosts stamina For common symptoms of PMS Claims that do not require FDA approval For hot flashes Helps you relax Helps enhance muscle tone or size Relieves stress Helps promote urinary tract health Maintains intestinal flora For hair loss associated with aging Prevents wrinkles For relief of muscle pain after exercise To treat or prevent nocturnal leg muscle cramps How are Dietary Supplements Regulated? Food rules apply; ingredients are presumed safe based on history of use in humans and, if sold in U.S. before Oct 1994, FDA review before marketing is not required Manufacturers do not have to provide FDA evidence of efficacy or safety before marketing; once on the market, FDA must prove that a product is not safe in order to restrict its use or remove it By contrast, for drug products, a manufacturer must obtain FDA approval by providing evidence of both safety and efficacy before marketing What are Americans using? Product Rate of Use Echinacea (40.3) Ginseng (24.1) Gingko (21.1) Garlic (19.9) Glucosamine (14.9) St. Johns wort (12.0) Peppermint (11.8) Fish oils (11/7) Ginger (10.5) Soy (9.4) Source: NIH NCCAM (2004) How Many People are Using Dietary Supplements Today? Estimated 40-55% of Americans use supplements on a regular basis, >100 million people Estimated 69% use vitamin & mineral supplements; 24% use herbal supplements Users predominantly adult women 42-55% and adult men 30-42% How are Consumers Using Herbals ? Of those taking herbals: 36% are using instead of prescription medication 31% are using with a prescription medication 48% are using instead of an OTC medication 30% are using with an OTC medication Herbs: Myths and Reality Natural is not equal to safe Used for thousands of years is not equal to effective & safe Herb as a plant is not the same as a capsule or tablet All brands of herbs are not the same Summary of HHS Actions on Specific Supplements FDA Advisories St. John’s Wort – Feb. 2000 (CDER, Public health) Aristolochic acid – Apr. 2001 (CFSAN, consumers) Kava – Mar. 2002 (CFSAN, consumers) Androstenedione – Mar. 2004 (FDA warning to manufacturers) Bans Ephedra – Feb. 2004 T-Bomb IIT-Bomb II T-BOMB II is so effective at jacking your Testosterone levels to the max, many are calling this male hormone optimizing formula "the most significant development in Pro-Testosterone Technology since prohormones! "It's the ONLY "prohormone-free" Testosterone formula available that simultaneously optimizes pure Testosterone levels in the blood, increases "Free Testosterone", improves the Testosterone to estrogen ratio and maximizes the anabolic effects of pure Testosterone. Never before has a Testosterone formula attacked the physiology of the human hormonal profile from so many angles! NOZ Full Throttle NOZ Full Throttle contains Creatine Ester Orotate, Isoleucine KIC, Glycine Ethyl Ester (GEE), Citrulline Ethyl Ester Malate, Alanyl-L- Glutamine-Dipeptide, Glycerol Monostearate, K-R-Alpha-Lipoic-Acid and Beta-Alanine Nitrix Rapidly Blow Up Muscles L-Arginine AKG - The Premier NO Booster! BSN has taken vaso-muscular volumization to the next level by developing a premier NO booster that ensures optimum NO production over current NO boosters. L-Arginine Alpha Keto-Glutarate (AAKG) has the unique ability to improve the conversion process of Arginine into NO. However, the NO boosting power of this specific amino acid is heavily dependent upon the bonded ratio of L-Arginine to AKG. After months of extensive research BSN has developed a precise bonded ratio of L- Arginine to AKG. This ratio promotes an increase in NO production over standard bonded versions of L-Arginine AKG. BSN's proprietary AAKG technology makes Nitrix the world's premier NO booster Mega Hoodia Fueled by Hoodia gordonii, the plant's most popular and effective species, new Mega Hoodia from NOW delivers a powerful 20:1 concentrate of pure Hoodia. Hydroxycut Hardcore Hydroxy citrate Garcinia cambogia fruit Caffeine Side effects Increased blood pressure Increased heart rate Headache, dizziness Loss of appetite Restlessness Nose bleeds Blurred vision acne St. John’s Wort Claims: Today, used for depression, anxiety, sleep disorders; traditionally to treat mental disorders, nerve pain & malaria, as a sedative & balm for wounds, burns & insect bites. Science: Not a proven therapy for depression; NCCAM is studying use for minor depression Side Effects: Interactions w/medications— indinavir (HIV infection), irinotecan (cancer), cyclosporine (organ transplant), digoxin (heart muscle contractions), warfarin (anticoagulant), birth control pills; w/some antidepressants may increase nausea, anxiety, headache & confusion FDA PUBLIC HEALTH ADVISORY February 10, 2000 Subject: RISK OF DRUG INTERACTIONS WITH ST JOHN’S WORT AND INDINAVIR AND OTHER DRUGS Dear Health Care Professional: The NIH conducted a study that showed a significant drug interaction between St John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, and indinavir, a protease inhibitor used to treat HIV infection… concomitant administration substantially decreased indinavir plasma concentrations… CONSUMER ADVISORY April 11, 2001 FDA WARNS CONSUMERS TO DISCONTINUE USE OF BOTANICAL PRODUCTS THAT CONTAIN ARISTOLOCHIC ACID The FDA is advising consumers to immediately discontinue use of any botanical products containing aristolochic acid… Consumption has been associated with permanent kidney damage, sometimes in kidney failure requiring kidney dialysis or kidney transplantation. Some patients have developed certain types of cancers, most often in the urinary tract. Kava KAVA-CONTAINING DIETARY SUPPLEMENTS MAY BE ASSOCIATED WITH SEVERE LIVER INJURY The FDA is advising consumers of the potential risk of severe liver injury associated with the use of kava- containing dietary supplements…promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. Take Home Messages Natural does not equal safe Dose matters (even essential nutrients can be toxic in sufficient quantities) Buyer beware – know what you are consuming to protect your health & wallet Check out these government websites: http://www.cfsasn.fda.gov/~dms/supplemnt.html http://ods.od.nih.gov/health_information/health_information.aspx What are Ramen Noodles? . How are they made? Mix dough Extrude Dry partially Fry Cool Package Ramen Noodles Noodles: Enriched flour (wheat flour,niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), partially hydrogenated soy oil, salt, soy sauce (water, wheat, soybeans, salt), potassium carbonate, sodium phosphates, sodium carbonate, turmeric. Ramen Sauce Sauce mix: Salt, dehydrated soy sauce (wheat, soybeans salt, maltodextrin),sugar, monosodium glutamate, lactose, beef flavor(dehydrated beef extract, cooked beef powder),autolyzed yeast extract, caramel color, natural flavors, spices, hydrolyzed corn, soy and wheat proteins, dehydrated vegetables (onion, garlic),beef fat, disodium inosinate, disodium guanylate. Marshmallows Marshmallows Corn syrup, sugar, modified food starch, water, gelatin, artificial vanilla flavor, tetrasodium pyrophosphate, Blue 1 Dried Potatoes Topco Scalloped Potatoes Dehydrated potato with preservative (sodium bisulfite), enriched flour (niacin, iron, thiamin mononitrate, riboflavin, folic acid), food starch - modified, salt, maltodextrin, whey, corn syrup solids, partially hydrogenated soy oil with emulsifier (mono and di glycerides) cheddar cheese(milk, cheese culture, salt, enzymes), hydrolyzed corn and soy protein, monosodium glutamate, buttermilk, reduced lactose whey, dextrin, dehydrated celery, sugar, corn starch, soy flour, chicken fat, natural and artificial flavor, autolyzed yeast extract, disodium phosphate, dehydrated onion, spice, color (paprika, yellow 6 lake, yellow 5 & 6, turmeric), dehydrated garlic, sodium caseinate, blue cheese (cultured milk, salt, enzymes), lactic acid, citric acid, disodium guanylate, disodium inosinate. Slim Jim Slim Jim Ingredients Beef, mechanically separated chicken, water, salt, corn syrup, dextrose, flavorings, spice, paprika, hydrolyzed corn gluten, soy and wheat gluten proteins, sodium nitrite, lactic acid starter culture. Slim Jim Mix ingredients Grind Stuff into casings Ferment Cook and Dry Dasani - Pure? Ingredients: water, magnesium sulfate, potassium chloride, salt Dasani - Pure? Who regulates water? – EPA – FDA - bottled Where could you find the rules? Dasani - Pure? Code of Federal Regulations (CFR) 21 CFR 165.110 Can ingredients be added to bottled water? Bottled water is defined in 21 CFR 165.110 as water that contains no added ingredients, except for optional antimicrobial agents or fluoride. Therefore, firms cannot add any other ingredients to their bottled water products and still call it "bottled water" (or "mineral water" or "purified water"). The name of a product with ingredients added must include the added ingredient, such as "bottled water with minerals added" or "bottled water with raspberry flavor." The resulting product is a multicomponent beverage and must bear an ingredient list on the label or labeling. If the water ingredient is highlighted as a bottled water, such as spring water, the water ingredient must comply with FDA's bottled water regulations.
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