Quiz 1 material
FDAMA (FDA Modernization Act) Health Claims (Health Claims Authorized Based on an Authoritative Statement by Federal Scientific Bodies)
"Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers'Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke."' duce the risk of [dental caries or tooth decay] "Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease." Replacing saturated fat with similar amounts of unsaturated fats may reduce the risk of heart disease. To achieve this benefit, total daily calories should not increase."
The Food and Drug Administration Modernization Act (FDAMA) of 1997 provides another way for FDA to authorize health claims, whereby health claims may be based on an
"authoritative statement" from a scientific body of the U.S. Government or the National Academy of Sciences
Health claim has two essential components
(1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. For example, statements that address a role of dietary patterns or of general categories of foods (e.g., fruits and vegetables) in maintaining good health are considered to be dietary guidance rather than health claims. Unlike health claims, dietary guidance statements and structure/function claims are not subject to premarket review and authorization by FDA.
Dietary supplement manufacturers are permitted by law to make four types of claims for supplements
(1) health claims, (2) qualified health claims, (3) structure/ function claims, and (4) nutrient content claims.These claims can be expressed as a written statement, third-party reference, symbol, or vignette.
Authoritative statement
(1) is "about the relationship between a nutrient and a disease or health-related condition" for a health claim, or "identifies the nutrient level to which the claim refers" for a nutrient content claim, (2) is "published by the scientific body" (as identified above), (3) is "currently in effect," and (4) "shall not include a statement of an employee of the scientific body made in the individual capacity of the employee."
Person vs Shalala
- 2001 Duke Pearson and Sandy Shaw from the Life Extension Foundation sued the FDA for limiting their freedom of speach a. Antioxidants and cancer
Supplement Market
- >10$ billion annually: retail, catalog, direct sales, multilevel marketing
International food Policies
- Canada and Australia are adopting U.S - Japan as FOSHU; Foods for Specified Health Use
DSHEA definition of dietary supplements as products that meet the following criteria
- Contains one or more of the following: vitamin, mineral, herbs, etc - Intended for ingestion in a tablet, capsule, powder, softgel - Labeled as dietary supplement - Cannot be represented for use as a convenctional food or as a sole item of a meal or diet - Cannot include an article that is approved as a drug or biologic
Forms Used
- Dried - Extracts or tinctures: aqueous (decoctions), ethanol, glycerin - membrane or supercritical fluid extract
Structure Function Claims
- FDA does not approve this - Manufacturer must submit a claim to the FDA with 30 days of selling the product - claims must be truthful and not misleading and must bear the disclaimer: The product is not approved by the FDA. The product is not intended to diagnose, cure, treat or prevent disease
Change in Policy in 2002
- FDA said that scientific agreement is not enough and that you must provide proof - And it changed how the qualified claims are approved
Nutrient Content Claims
- Food or dietary supplement state the amount of nutrient present - Vitamin C, E and betacarotene supplement - Dietary supplement labels can only state the amount present since DRIs do not exist for many compounds
Changs in the 90s
- NLEA created more interest in nutrition - FDA began prosecute supplement markers who made claims - The supplement industry mounted a campaign to give them more freedom and enlisted Senator Orrin Hatch of Utah
Operation Supplement Safety OSS
- OSS for armed services and their families
Claims allowed under DSHEA
- Related to classical nutrient deficiency benefit - Description to the role or mechanism of an ingridient intended to affect or maintain a structure or function in the body - general well-being from consuming a supplement ingridients Some health claims are permitted under NLEA
Marker Compounds
- Some herbs have characteristic or marker compounds - Market compounds may not have bioactivity - herb products "standardized" to a certain level may not have health value
Clarifying Claims
- Suggestive product names - 2000 ruling about s-f fusion claims - aging, menopause and pregnancy are not considered diseases
Changes in Herb and Diet Supplement Use in US Adults Population Comparissons
- Use rose from 1990-200s - 50.6 2002- 55.1 2007 - Proportion decreases for 12 months 19-18 - DIsclose to med rose- 33--> 44 - <1% disclose to pharmacist - they are popular but they change - 1999-2002 doubled 9-18% Dropped slighly
Solvents for Extraction
- Water does not extract many compounds - Ethanol is preferred bt some may avoid - Hexane is cheap and effective but toxic: solvent removal is critica
third party literature
- area of concern of the FTC and FDA= the referral or availability of books, materials or articles - readings displayed in stores should not be misleading
Advertising Guide of the FTC
- must be truthful and not misleading and before releasing an ad, advertiser must have adequate substantiation for all objective product claims Must have proof for claims
Commission E Monographs
- not always accurate and poorly referecnes - Emphasis on European and North American hervs herb states: approved, not approved, approved component characteristics
Ephedra (Ephedra sinica)
- used in teas to loosen congestion - decrease appetite weight loss supplements combined ephedra extracts with caffeine to intensify activity
Particle Reduction
-grinding, chopping can create heat by friction loss of active compounds: oxidations and volatile compounds evaporate - Extraction from small particles is more efficient
QUALIFIED HEALTH CLAIMS
0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form. FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects. Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive. or,
NDI is considered adulterated unless
1) "the dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered" or (2) the manufacturer submits a NDI notification (NDIN) at least 75 days before the product is introduced into the market
TC's truth-in-advertising law can be boiled down to two common-sense propositions:
1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.
Structure/function claims differ from health claims because
1) health claims require FDA evaluation and authorization prior to use, whereas structure/function claims do not require FDA preapproval and (2) structure/function claims may not explicitly or implicitly link the relationship to a disease or health-related conditio
DSHEA
1) health claims specifically authorized by the FDA; and 2) statements of nutritional support. Health claims — representations about the relationship between a nutrient and a disease or health-related condition — are permitted only if they have been authorized by an FDA finding that there is "significant scientific agreement" to support the claim.
AND guidelines regarding the recommendation and sale of supplements
1. Assement 2. Document 3. Report 4. Best Interest 5. Recommendation based on science 6. Complementary to diet
Guidelines supplements:
1. Assessment 2. Recommendations should include science evidence 3. Complementary to diet 4. Made in the best interest 5. Report 6. Document 7. Assumes responsability and accountability 8. Meet unique needs of patient
DSHEA supplements must meet one of the following:
1. Contains one or more of the following: vitamin, mineral, herb, amin, substance to supplement the diet by increasing the total dietary intake, concentrate, metabolite, constituents, extract, combination : a. Intended for ingestion as a capsule b. Labeled as dietary supplement c. Cannot be represented for use as a conventionalfood or a sole item of meal or diet d. cannot include an article that is approved as a drug or biologic
Basic lifestyle management
1. Diet and Nutrition 2. Exercise and fitness 3. Stress management 4. addition and habit management 5. Spirituality and religion
Top Ten Functional Foods Named by Consumers
1. Fruits/vegetables 2. Fish/Fish Oil 3. Dairy 4. herbs/Species 5. Whole Grains 6. Fiber 7. Meat and Poultry 8. Tea 9. Nuts 10. Vitamin and Supplements
Regulatory Requirements for the Labeling of Beverages and Liquid Dietary Supplements
1. General prohibition on false or misleading labeling 2. Health claims
DSHEA Definition of Dietary SUpplement
1. It is a product that is intended to supplement the diet and it is at least one or more of the following categories: a. vitamin b. mineral c. herb d. amino acid e. dietary susbtance f. concentrate, metabolite, extract, constituent or any of these ingrideints 2. Inteded to be ingested in : tablet, capsule, softgel, liquid or powder 3. No convectional food or meal 4. Labeled as "dietary supplement" 5. Drugs or antibiotics that were marketed as a supplement or food before approval
Factors that Distinguish Beverages from Liquid Dietary Supplements
1. Labeling nd advertising: convectional foods if it bears the statement refresh or rehydrate; represent the use as a convectional foods. Also an add or a picture of a liquid product being poured into a green salad. 2. Product name: drink, water, beverage, soda, 3. Product packaging: soda can 4. Serving size and recommended daily intake: used or replaces beverages that serve as ordinary sources of drinking fluid 5. Recommendations and directions for use: beverages are designed to quench thirst provide source of fluid, nutrition value or taste and aroma. 6. Marketing practices: labeling, ad and other promotional activities that compare the product to a category of beverages, market the product as an accompaniment to a meal or market the product based on a typical beverage critiria like taste, refreshment, and thirst quenching ability and use of metatarsi; however, simply recommending that a liquid product be taken with a meal would not generally be considered to represent the product as a convectional food , or recommending it as a substitute for example a labeling or ad statement promoting liquid vitamin c supplement would not represent convectional food because it would be promoting the supplement s a moe convenient source of cvitamin C, not a beverage for thirst 7. Composition
NIH Model for CAM; complementary medicine (categories)
1. Mind and Body interventions 2. Alternative Systems medical practice 3. Manual of healing methods 4. Pharmacological and Biological treatments 5. Diet and Nutrition 6. Herbal Medicine
Proxmire Amendment
1. No limits on vitamin potency 2. Freedom to develop new products (to manufacturers) 3. Classified as a drug if the potency exceeds what is nutritionally sound level. Example: Niacin 1-3 grams DRI: 16 mg Used to lower serum lipids and treat schizophrenia adverse effects: skin flushing, hyperglycemia, liver damage, jaundice, duodenal ulcers ,pruritus
Pharmacokinetics
1. Phytochemical pharmacokinetics requirements: a. identification of pharmacologically active chemicals b. Determination of nature of the pharmacologic activity and probable mechanism 2. Determination of the active chemical component possibilities a. Native plants b. food processing produt c. digestive enzyme changes d. Gastrointestinal changes alternations such as saturations
Regulatory Requirements for Ingredients of Beverages and Liquid Dietary Supplements
1. Substances intentionally added to beverages 2. Dietary ingredients in dietary supplements 3. Substances (other than dietary ingredients) intentionally added to dietary supplements
Reasons for using CAM
1. pragmatism; not cure, cause unknown, cost 2. holism 3. spirituality 4. life-style changes
Alcohol limits
10%; adults 5%- 6-12 .5%- <6
The responsible person must submit a serious adverse event to FDA no later than
15 business days after the report is received; any new medical information related to a previously submitted adverse event report must be submitted to the agency within one year of the initial report, and within 15 days of receipt
Looks like...
16 Century: Doctrine of Signatures: appearance color and shape indicates use red plants good for blood quaking aspen for palsy ginseng for general health and energy
Important Federal Laws
1906- Food and Drug Act 1938: Food, Drug and Cosmetic Act FDCA 1976: Proxmire Ammendment to FDCA 1990: Nutrition Labeling and Education Act 1992: Dietary Supplement Act 1994: Dietary Supplement Health Education Act 1997: Food and Drug Administration (FDAM) Modernization Act
Supplement Regulations
1976: Proxmire Amendment to FDCA 1992: Dietary Supplement Act 1994: DSHEA 1997: Food and Drug Administration Modernization Act
International Food Council Functional Foods Attitudinal Research
2011, phone interview, 1000 people follow-up assessed awareness and food-health relationship Show that 90% name a benefit and 76% felt that food was good for health
Examples of nutrient supplement recommendations
400 IU daily of supplemental Vitamin D for infants nd children Women of childbering age who may become pregnant: 400g of folic acid Pregnant women: 600 ug/day of folic acid Older adults: people over age 50 get 2.4 ug/day vitamin B12
Household expenditures on dietary supplements sold for weight loss, muscle building, and sexual function: Disproportionate burden by gender and income
A recent national study found 21% of women and 10% of men had used weight-loss supplements at some point in their lives, with women ages 18-34 years having the highest rate of past year use at 17%, affecting many millions of AmericansDietary supplements sold for weight loss, muscle building, and sex- ual function are purchased by a range of household types defined by gender of household head and annual household inco
CAM therapies included in 2007 NIH
Acupuncture Ayurveda Biofeedback Chelation therapy Chiropractic or osteopathic medicine Deep-breathing exercises Diet and Nutrition Energy healing; Reiki Guided Imagery Hypnosis Homeopathic Massage Meditation Movement therapy Natural products Naturopathy Progressive relaxation Qi Gong Tai Chi Yoga Traditional healers: native americanhealer/medicine man, shaman, yerbero/hierbera, curandero, espiritista, sobadors, botanida
Facts from IFC (international food council)
Americas believe that they have some control over health and nutriotn play the most important role Consumer awareness has increased since 1998 Food Benefit to this two health concerns like Ca and vitamin D But consumption and these foods has not changed since 2005
Garlic
Associated with decreased cholesterol levels and prevention of infections Garlic chemicals change rapidly due to: heat, oxygen and enzymes Allinase changes
Diseases for CAM in adults
Back pain neck pain joint pain arthritis Anxiety cholesterol cold other migrane Inmsomnia
Diseases for which CAM is used for in children
Back/neck Pain Head/Chest Cold Anxiety/Stress Other muscoskletal ADHD Inmosinia
Bioavailability and pharmacokinetics
Bioavailability is measured in the plasma levels after oral dose Pharmacokinetics: derived from the plasma levels after a short period of tie after a single dose
Allincin Metabolism
Blo: not allowing found in the blood after consumption Liver: 99% lost after oney s9x minus of exposure to liver tissues
Reason why physician recommend CAM
Bone health, overall health, healthy living, decrease cholesterol and heart health
Adverse Event reporting
CAM providers: contact state licensing office for that speciality Dietary Supplements; contact FDA state consumer complain coordinators FDA safety reporting portal
Top Health Concerns
CVD Weight Cancer Physical Activity Sleep Diet/Nutrition Healthy aging Diabetes Mental Health
Types of Medicine
Complementary Alternative Orthodox (allopathic)
Dietary Guidance example
Consuming at least 3 or more ounce-equivalents of whole grains per day can reduce the risk of several chronic diseases Carrots are good for your health," or "Calcium is good for you.
DSHEA definition of dietary supplement
Contains any of the following ingredients; vitamin, mineral, herb, amino acids, diet substance, extract, concentrate, metabolite,
Imported Herb Issues
Contaminants: faith, pesticide, mycotoxins, wrong plant, environment and economic damage
Industrial Groups
Council of Responsable Nutrient: 100 companies that sets the dosing levels and GMP; good manufacturing practices Dietary Supplement Education Alliance a. American herbal product association b. National Nutrition Foods Association c. American Botanical Council d. Corporate Alliance for Integrative Health Medicine
Dietary supplement cGMPs have been in place since June 25, 2007, when FDA published the final rule,
Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, in the Federal Register
Legislative Changes
Dietary Supplement Act of 1992 required FDA to develop new rules on labeling and claims DSHEA was passed in 1994 to: a. Define supplement and dietary ingridients b. Set criteria for labeling regulations c. Establish an NIH office of dietary supplements
1994
Dietary Supplement Health and Education Act of 1994
DSHEA
Dietary Supplement Health and Education Act of 1995
EMA
Economically Motivated Adulteration
Major Safety Issues
Ephedra: death Pyrrolizidine Alkaloids: liver (comfrey) Aristolochic acid: carcinoge Kava: liver damage
Name problems
Eupatorium perfoliatum: boneset, feverwort, thoughtwort Saw palmetto: serbia repetens, cabal serrulata, corypha repends
OxyElite Pro and Liver Disease
FDA received 114 cases: 33 hospitalization and 3 transplants in 2012-2014 - 32 states, 2 foreign contries and PR - 48% notes liver disease Investigations revealed that the manufacturer replaced 1,3-dimethylamylamine with angeline which is not suitable dietary supplement ingredients
FDCA
Federal Food, Drug, Cosmetic Act
Photo-sensitizing Products
Food and Herbs: parsley, celery, lime and St. John's wort Tanning booths and phototherapy could cause reaction
United Kingdom
Food supplements are regulated under food law.
Functional foods
Foods or food components that may provide benefits beyond basic nutrition
What happened in 1992?
Formation of National Center of Complementary and Alternative Medicine= (now) National Center of Complementary and Integrative Health (NCCIH)
Herb Assessment Issues
Frequency Dosage, strength and form Source Reference Information
What is the name? q
Genus, specially, Name of the person who named the species chinee or other ethnic name
Harm Level 1-3
Ginger, Black cohosh, ephedra (level A evidence) B evidence: green tea, St. John's wort, bitter orange C: aloe vera, licorine, chaparral
Botanical ingredients in DS
Gingko biloba
Analysis of Herbs Components
HPLC: High performance liquid chromatography Capillary Electrophoresis (CE) Mass Spectrometry (MS)
Label Claims
Health (authorized/qualified): used to characterizee the relatiosnhip between dietary ingridient and reducing the risk. Nutrient Claims: amount of nutrient Structure/Function: Describe the effect, way, act to maintain, benefits, general wellness. It is not approved and required approval, 30 days
Rosacea
Important plants are hawthorn (Crataegus sp.), dropwort (Filipendula ulmaria), dog rose (Rosa canina),
Canada
In 2004, under the Canadian Food and Drugs Act, the Natural Health Product (NHP) regulations were enacted.Unlike the US regulatory landscape where dietary supplements are primarily monitored post-market for signs of adversity, Canada's NHPD requires products to be licensed prior to market entry.
An advertiser claims that its product has been "studied for years abroad" and is now the "subject of U.S. government-sponsored research."
In addition to the explicit claim that the product has been studied, such phrases likely convey to consumers an implied claim that there exists a substantial body of competently-conducted scientific research supporting the efficacy of the product. The advertiser would be responsible for substantiating both claims.
An advertisement for a vitamin supplement claims that 90% of cardiologists regularly take the product. In
In addition to the literal claim about the percentage of cardiologists who use the product, the ad likely conveys an implied claim that the product offers some benefit for the heart. Therefore, the advertiser must have adequate support for both representations.
n advertiser relies on animal and in vitro studies to support a claim that its vitamin supplement is more easily absorbed into the bloodstream than other forms of the vitamin. However, the animal research uses a species of animal that, unlike humans, is able to synthesize the vitamin, and the in vitro study uses a different formulation with a higher concentration of the compound than the product being marketed.
In addition, human research is feasible and relatively inexpensive to conduct in light of the potential sales of the product and is the type of research generally accepted in this particular field of study. The substantiation is likely to be inadequate in this case, both because there are significant methodological problems and because, in this particular instance, human research is both feasible and the accepted approach in the field.
IFM
Institute of Functional Medicine
Factors that will drive demand of supplements in U.S
Interest Subpopulations Technology Science evidence Niche Markets Changes in Food regulations Cost of Health care
FSMA was enacted on
January 4, 2011, and expanded on this authority by amending the FDCA to require that facili- ties engaged in manufacturing, processing, packing, or holding food—including dietary supplements—for human or animal consumption in the United States to submit additional registration information to FDA. FSMA requires all food facili- ties, including dietary supplement companies, to renew their facility registrations every other year
Safety Concerns
Lack of child-proof packaging Contaminants: drugs, heavy metals, microbes, mis-labeled products, pesticides Drug interactions
Naming botanicals
Latin name made up: genus and species
Other Plant Parts
Leaves: Folium Flower: Flos fruit: Fructus Seeds: Semen Stems: Caulos Bark: cortex or corticis- cinnamon
Usnic acid
LipoKinetix
All patients/clients should receive a complete assessment of diet and dietary supplement use as a routine component of their nutritional status assessment. Assessment should include:
List of supplements Dose/frequency Brand/chemical form Rationale for use (patient/client perspective) Evaluation of diet and supplement adequacy
Holding and Distribution
Manufacturers must establish measures to protect components, dietary ingredients, dietary supplements, packaging, and labels against contamination and deterioration. In addition, they must ensure proper holding conditions including, but not limited to, appropriate temperature, humidity, and light
Ericaceae
Most frequently used species are bilberry (Vaccinium myrtillus), American cranberry (Vaccinium macrocarpum) and blueberry (Vaccinium corymbosum).
Races for CAM
Native American: 50.3% White: 43% Asian: 40% Black: 25.5% Hispanic: 23%
10 Most common CAM therapies
Natural Products Deep Breathing Chiropractic/Osteopathic Medicine Massage Yoga Diet-Based Therapies Progressive Relaxation Meditation Guided Imagery Homeopathic Medicine
% of Adults who used complementary medicine
Non-vitamin supplements: 17.5% Chiropractic: 8.5% Yoga: 8.4% Massage: 6.8% Meditation: 4.1% Special Diets: 3.0%
Nutrient Content Claims
Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite.
DSHEA classified all dietary ingredients marketed in the United States before October 15, 1994 as
ODI- old dietary ingredients; and were considered safe for continued consumer use
10 Most common products for adults
Omega 3 and fish oil Glucosamine Echinacea Flax seed oil Ginseng Combination of herb medicine gingo biloba Chondration Garlic Supplements Coenzyme Q13
Radial from integrative and functional medical nutriton therapy
Personalized Care Influenced by: Lifestyle: food, sleep, culture, System Signs and Symptoms: circulatory, digestive, endorine Biomarkers: anthropomtrics, digestion/absoprtion, genemocs/SNP's Metabolic Pathways/Networks: anabolic/catabolic, cellular respiration, biotransformation Core Imbalances: cellular integrity, digestion, energy metabolism, detoxification
Kava Kava Saftey
Piper methysticum grows in the pacific islands Traditionally the rhizome and roots are made into a beverage that men share The herb contains kavalactones solvent extracts do not contain glutathione which protects the lvier
Powdered Premix Products and Liquid Concentrates May Be Dietary Supplements
Powdered premixes may bear directions recommending that the premix be added to a liquid as a convenient delivery system, for other reasons of convenience or stability (e.g., if the ingredients are not stable in aqueous solutions), or to mask the taste of certain ingredients. We generally do not view such products as beverages when they are labeled as dietary supplements, provided that they are not otherwise represented as being for beverage use or as alternatives to beverages. Likewise, we generally would not view liquid concentrates that are added to water or other liquids as beverages when they are labeled as dietary supplements, provided that they are not otherwise represented for beverage use or as alternatives to beverages
standardization
Process to ensure consistency of products; identify chemicals and measure quality control. Standardized" on a supplement label does not necessarily indicate product quality.
To avoid tainted supplements, don't buy any of these:
Products that claim to work like prescription drugs - anything that claims to treat an illness or cure a medical condition Products that are advertised through mass e-mails Products marketed mainly in a foreign language Products that promise weight loss, body-building, or enhanced sexual performance Products that say they are a legal alternative to anabolic steroids
Summary of Qualified Health Claims Subject to Enforcement Discretion
Qualified Health Claims About Atopic Dermatitis Risk 100% Whey-Protein Partially Hydrolyzed Infant Formula and Reduced Risk of Atopic Dermatitis Qualified Claims About Cancer Risk Tomatoes and/or Tomato Sauce & Prostate, Ovarian, Gastric, and Pancreatic Cancers Calcium and Colon/Rectal Cancer & Calcium and Recurrent Colon/Rectal Polyps Green Tea & Cancer Selenium & Cancer Antioxidant Vitamins & Cancer Qualified Claims About Cardiovascular Disease Risk Nuts & Heart Disease Walnuts & Heart Disease Omega-3 Fatty Acids & Coronary Heart Disease B Vitamins & Vascular Disease Monounsaturated Fatty Acids From Olive Oil and Coronary Heart Disease Unsaturated Fatty Acids from Canola Oil & Coronary Heart Disease Corn Oil & Heart Disease Qualified Claims About Cognitive Function Phosphatidylserine & Cognitive Dysfunction and Dementia Qualified Claims About Diabetes Psyllium Husk & Diabetes NEW Chromium Picolinate & Diabetes Qualified Claims About Hypertension Calcium & Hypertension, Pregnancy-Induced Hypertension, and Preeclampsia Qualified Claims About Neural Tube Birth Defects 0.8 mg Folic Acid & Neural Tube Birth Defects
FTC Advertising Regulation; federal trade commission
Regulates advertising for most consumer products, including dietary supple- ments, to ensure that consumers receive accurate and truthful information about the products they purchase.
Underground Plant Parts
Roots (radix); lower moisture, better storage Rhizomes: underground steams
Labeling Dietary Supplements
Serving size calories, calories from fat, total fat, saturated fat, cholesterol, sodium, iron, fiber, sugars, total carbohydrate, protein, vitamin A, C, and calcium Ingredients for which there are no % DV can be listed
Dietary supplement stat contain the highest number of potential interactions
St. Johns wort, magnesium, calcium, iron, Ginkgo biloba
Brassica Oleracae L.
Steams and flower bus: broccoli Leaves: kale, spinach Inflorescense lacking: cauliflower Swollen stems: Kohlrabi Large Head or stout stem: cabbage Enlarged ancillary buds: brussel sprouts
FDCA, as amended by DSHEA [84], permits claims to be made for dietary supplements if
T]he statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.
Dietary Supplement Label Database for Registered Dietitian Nutritionists
The DSLD is publicly available through the National Library of Medicine's web portal
Health Claims Based on Authoritative Statements
The Food and Drug Administration Modernization Act of 1997 (FDAMA) provides a second way for the use of a health claim in food labeling to be authorized.
harm by pfs
The Netherlands, more than 60 people showed nausea and vomiting after drinking a herbal tea called 'starmix tea' containing star anise, and 22 people were hospitalized due to tonic-clonic insults This adverse effect was associated with the prolonged intake of a Chinese herb-based weight loss prepara- tion in which Stephania tetranda was accidentally replaced by Aristolochia fanchi, because both plants are used under the same name 'Fangji' in Chinese folk medicine.
An advertiser for a weight loss supplement cites a placebo-controlled, double-blind clinical study as demonstrating that the product resulted in an average weight loss of fifteen pounds over an eight-week period. The weight loss for the test group is, in fact, significantly greater than for the control subjects. However, both the control and test subjects engaged in regular exercise and followed a restricted-calorie diet as part of the study regimen.
The advertisement should make clear that users of the supplement must follow the same diet and exercise regimen to achieve the claimed weight loss results.
An advertisement claims that "university studies prove" that a mineral supplement can improve athletic performance.
The advertiser has expressly stated the level of support for the claimed benefit and is therefore responsible for having "university studies" that document the advertised benefit. Furthermore, the implied reference to scientific evidence likely conveys to consumers the implied claim that the studies are methodologically sound.
An advertisement for a supplement claims that the product will cause dramatic improvements in memory and describes the experiences of 10 people who obtained these results.
The descriptions of these anecdotal experiences are truthful, but the advertiser has no scientific substantiation for the effect of its product on memory and cannot explain why the product might produce such results. The individual experiences are not adequate to substantiate the claim without confirming scientific research.
Ads that Refer to a Specific Level of Support An ad for a supplement includes the statement "Scientists Now Agree!" in discussing the product's benefit.
This statement likely conveys to consumers that the state of science supporting the benefit has reached the level of scientific consensus. Unless the advertiser possesses this level of evidence, the claim is not substantiated.
Authorized Health Claim
Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving."
Two examples of an authorized health claim, which by definition must contain the elements of a substance and a disease or health-related condition, are:
Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving." and "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease
Dietary Supplement users vary in attitudes and sources of dietary supplement inforamtion
Total population 72% reported taking dietary supplements and living in the west coast had a greater use East coast believed supplements to be essential and were confident
Basic Considerations
Which herb? plant part, processed part Interactions: other herbs, drugs, food
Domestication and systematic cultivation, in contrast, offers a number of advantages over wild-harvest:
a) avoidance of admixtures and adulterations by reliable botanical identification, b) better control of the harvested volumes, c) selection of genotypes with desirable traits, especially quality, and finally, d) controlled influence on the history of the plant material and on post-harvest handling.
all product labels must be
accurate, easy to read, and specific to the product
Senna Noni juice Ma huang
acute and subacute liver damage
The Food and Drug Administration Modernization Act of 1997 (FDAMA)
allows health claims that are based on "authoritative statements" from certain federal scientific bodies, such as NIH and the National Academy of Sciences.
Tea
also known as infusion, made by boiling was rot fresh or dried botanicals and steeping them
germ plasm collection
appropriate propagation methods has to be developed and it is the first phase of domestication
Quality control personnel responsibilities include
approving or rejecting all materials, processes, controls, labels, and finished products and ensuring that testing is conducted on established specifications.
Proposition 65 requires the Governor of California to publish
at least annually, a list of chemicals known to the state to cause cancer or reproductive toxicity
Adverse effects of garlic
bad breath and body olor acid reflux due to esophageal relaxation increasing concerns about garlic compounds
Water processed garlic may be less hepatoxic
because cholesterol decrease but cell bumber syays the same Allicing derived oil solutel sulfur compounds
Survey samples
captive groups (students and senior), physician, health store and random groups
Variability
chemical composition varies by: plant part, variety, growing conditions, season and processing
Position of the American Dietetic Association Nutritient Supplemetn
choosee a wide variety of fruits and additional nutrients from supplement can help
Prior to the Food and Drug Administration Modernization Act of 1997 (FDAMA)
companies could not use a health claim or nutrient content claim in food labeling unless the Food and Drug Administration (FDA) published a regulation authorizing such a claim.
Package for a drug must include:
conditions the drug has been proven to treat Known side effects Contraindications Unsafe interactions with other drugs
Purity first Healthy
controversy
Ephedra Adverse Events
death, myocardial infarction, tachycardia, seizures, palpitations and hypertension
Dietary supplements are considered safe until proven unsafe
defined as a category of food, which put them under different regulations than drugs.
DSHEA accomplished these goals by
defining dietary supplements, affirming food safety standards, authorizing GMP regulations, and addressing nutritional labeling and claim
HEALTH CLAIMS
dequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis. Calcium, vitamin D and osteoporosis: Adequate calcium and vitamin D, as part of a well balanced diet, along with physical activity, may reduce the risk of osteoporosis. s. A diet low in total fat may reduce the risk of some cancers. Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.
Health Claims
describe the relationship between a food substance and reduced risk of a disease or health-related condition food and risk
Food and Drug Administration
dietary supplement, adverse event reporting, guidance, compliance and regulatory information
lemon balm
digestion, well being and support relaxation
Herbal dietary supplements may alter
drug pharmacokinetics by inducing or inhibiting P450 drug metabolizing enzyme and activity
1906- Food versus drug
drugs intended to: cure, treat, mitigate, diagnose or prevent disease and must be approved by the FDA and show proof of safety and efficacy.
Kava
effective action for anxiety
Qualified Health Claims
en there is emerging evidence for a relationship between a food substance (a food, food component, or dietary ingredient) and reduced risk of a disease or health-related condition, but the evidence is not well enough established to meet the significant scientific agreement standard required for FDA to issue an authorizing regulation, the qualified health claim petition process provides a mechanism to request that FDA review the scientific evidence and exercise enforcement discretion to permit the use of the qualified claim in food labeling.
Non-Vitamin Non-Mineral (NVNM)'' supplements,
encompasses botanicals, proteins, amino acids and even shark cartilag
Federal Trade Commission
enforces laws outlawing "unfair or deceptive acts or practices," is to ensure that consumers get accurate information about dietary supplements so that they can make informed decisions about these products
Significant liver injury was reported after intake of
erbalifes and Hydroxycut products, tea extracts from Camellia sinensis, products containing usnic acid and high contents of vitamin A, anabolic steroids and others.
Dietary ingredients already on the market prior to the 1994 passage of DSHEA, known as "old dietary ingredients" (ODIs),
ere excluded from the defini- tion of an NDIThis premarket notification to FDA must occur at least 75 days before marketing the new ingredient and must include information demonstrating that the ingredient "is reasonably expected to be safe.
Apiaceae
essential oils, fennel, caraway, aniseed
Barriers to consuming functional foods
expense, taste, availability/convinience, knowledge, confusion, confidence, desire and time
Ethical Issues
expertise dosage drug food interactions risk benefit ratio efficacy safety unbiased sales
bilberry
eye sigh
FTC
federal trade commission
most popular products are:
fish oil/omega 3, glucosamine, echinacea and flaxseed
DS that have the highest number of contraindications
flaxseed, echinacea and yohimbe
Factors Improving Overall Health
food/nutrition, exercise, family health history
What is the evidence regarding the effect of supplemental vitamin D on bone density in postmenopausal women and older adult men?
further research
What is the evidence regarding the effect of oral vitamin B-12 supplementation and/or oral fortification on serum cobalamin levels in deficient older adults?
further research and research is inconclusive regarding serum cobalamin concenratios with cognitive function in older adults
Araliaceae
ginseng
fish stomach
good for skin
A dietary ingredient introduced to the market after the passage of DSHEA is considered a new dietary ingredient (NDI). Manufacturers must submit a notifica- tion to the FDA at least 75 days before introducing a NDI to market to provide information regarding the identity of ingredient and justification that the NDI "will reasonably be expected to be safe"
gredients used in dietary supplements prior to the enactment of DSHEA on October 15, 1994 are considered "grandfathered" and may continue to be used without any notification to FDA
methamphetamine, N,α-diethyl-phenylethylamine and β-methylphenethylamine
has been found in supplements
Council for Responsible Nutrition (CRN), through its CRN Foundation, and the National Advertising Division (NAD) of the Council of Better Business Bureaus
have worked together to increase monitoring of advertising for dietary supplements and functional foods
net quantity of contents
informs consumers how much of the dietary supplement is contained in the package and must be expressed, either in weight or measure, numerical count, or a combination thereof
To qualifyy as a dietary supplement a botanical must:
is intended to supplement the diet; contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement.
Nutrient content claims characterize the
level of a nutrient or dietary substance in the product, either expressly or by implication. Examples include "high in antioxi- dants," "low calorie," "more fiber," and "reduced sugar."
FDA Modernization Act (FDAMA) Claims
linoleum acid, choline, fluoride, potassium and risk of high bloodd pressure and stroke, sutrated fat,cholesterol, trans fat and isk fo heart disease, subtitution of saturatedfat with unsaturated fatty acids and risk of heart disease, whole geains and heart disease and cancers
Assessment should include:
list of supplements, dose/frequency, brand/chemical form, rationale for use, evaluation of diet and supplement adequacy
Cassia angustifolia, Hydroxycut and Ephedra sinica
liver damage
Assessing Dietary Supplement Usage
long term vs current; current> s 10x year for calcium and vitamin differences could lead to assumptions of no relationship between nutrient intake and disease prevention
Tincture
made by soaking a botanical in a solution of alcohol and water and they are sold as liquids and are used for concentrating and preserving a botanical
Qualified health claims
may be used when there is emerging evidence for a rela- tionship between a dietary supplement and reduced risk of disease. Because these claims have less evidentiary support than FDA-authorized health claims, FDA requires qualifying language to indicate this reduced level of evidence
Where to learn about problem products
medwatch quackwatch consumer labs
black cohosh
menopause symptoms
Chamomile and peppermint
mild botanicals for digestion
Complementary and alternative medicine (CAM)
more recently known as integrative health or integrative medicine, is a diverse field comprising numerous treatments and practitioners of vari- ous levels of training
Functional Foods and Nutraceuticals
neither term is legally recognized in the US> defined nutracauticals: as food or food part hat provides medical or health benefit including prevention or treatment of disease
PDR for Herbal medicines
not as well document as drugs
the phrase servings per container is
not necessary i the new quantity of contents statement provides identical information
East coast
now significantly lower
AID
ocuses on the types of carbohydrates and fats, promotes the intake of dietary antioxidants by eating fruits and vegetables from the full color spectrum, and encourages changing from coffee to green tea (Camellia sinensis) to take advantage of the anti- oxidant polyphenols in green tea, and recommends that people increase consumption of culinary spices with anti- inflammatory properties such as ginger, turmeric, and garlic
Food additive is any substance added to food intended to affect the characteristic of a food, an
or a food additive to be approved for use, a manufacturer must demonstrate "reasonable certainty of no harm under conditions of intended use.
dandelion (Taraxacum officinale)
or weed , for urinary system
Sources for East and West Coast Information
physician, internet ( east cost the lowest), magazine, books, labels (east cost the highest)
PFT
plant food supplements
Botanical
plant or plant part values for its medicinal and therapeutic properties flavor or scent
OxyElite Pro
popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure. in 2013,FDA did not lead on the case until 4 months later and by 2014 it was linked to 47 hospitalization and 3 transplantations and 97 cases totoal
Agency for Healthcare Research and Quality
produce evidence-based reviews
Dung Chong Grass
promotes good digestion and strengthens the digestive immune system
The Supplement Facts box must list the % DV of all dietary ingredients, with the exception of
protein or dietary ingredients that do not have an established DRV (e.g., sugar), or if the label states that the product is intended for infants, children younger than 4 years of age, or pregnant or lactating women.
The 1990 Nutrition Labeling and Education Act (NLEA)
provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative
1997 Food and Drug Administration Modernization Act (FDAMA)
provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information
Swallow nest
purifies and strengthens the body, resistance to the body and aging
Advertising Supplement
regulated by the Federal Trade Commission FTC
European Union
regulations germane to the marketing and availability of dietary supplements (nutritional supplements) are complex and generally in a state of flux. T
Japan
regulations that specifically define a food supplement.(1) Foods with Nutrient Function Claims (FNFC) containing well-characterized vitamins and minerals with standardized preapproved claim statements with established benefits, or (2) Foods for Specified Health Uses (FOSHU)
Dietary Supplement and Nonprescription Drug Consumer Act, signed into law on December 22, 2006
requires that dietary supplement labels include contact infor- mation (the domestic address or phone number) for the "responsible person" who can receive reports of adverse events associated with the dietary supplement
Considerations for recommending CAM
safety, efficacy and cost
n 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements
set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.
valerian
sleep but after 14 days
Dietary supplement label must display
statement of identity (name of the dietary supplement), (2) net quantity of contents (amount of the dietary supple- ment), (3) nutrition labeling, ingredient list, (5) name and place of business of the manufacturer, packer, or distributor.
Safety Reporting Portal (SRP)
streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) and the National Institutes of Health (NIH).
herbs
subset of botanicals
Amount of dietary ingridient
supplements facts box
Source listed in
supplements facts box or ingredients statements located outside the supplements fact box
1/2 of the adults report
taking one or more supplements in the serious 30 days
How are botanicals commonly sold and prepared?
teas, decoctions, tinctures, and extracts
tatement of identity and net quantity of contents statement must appear on
the front label panel
Mountain region for supplements
the higherst
FDA also monitors
the labeling of dietary supplements to ensure that they are truthful and not misleading, and that they otherwise meet FDA require- ments for labeling. This includes product claims as well as identity information about a dietary supplement (e.g., ingredients, serving size). Products that do not meet these requirements are considered misbranded and subject to the same enforcement provisions as adulterated products, including injunction, seizure, recall, fines, and/or civil penalties.
Serving size
the maximum amount recommended on the label for consumption per eating occasion
Microscopy
the presence of crystals in the tissues or the occurrence of specialised cells
A primary goal of DSHEA
to create a regulatory framework for dietary supple- ments that would provide continued access to products that clearly had a history of safe use. The legislation sought to avoid regulatory obstacles and encourage innova- tion, while balancing the need to ensure the safety of dietary supplement ingredients, especially new or novel ingredient
Why people seek CAM?
trendy (celebrities), beliefs, cost, no other options, quick fix
Products made form botanicals
used to maintain or improve health may be called herbal products, botonical or phytomedicines
An overview of consumer attitudes and beliefs about plant food supplements†
variety of factors may be influencing this increased consumption including the increasing number of older people in society, mistrust in conventional medicine and the perception that natural is healthy Research indicates that higher use of dietary supplements has been associated with being female, being more educated, having a higher income, being white and being older, however the drivers for consumption of supplements are complex, being influenced by both demographic and health-related factors.
morphology
visible
Inadequate intake of nutrients:
vitamin A, C, D,E, Ca, Mg, iron, K, choline and fiber
Below EAR (estimated average requirement)
vitamin B6, B12, B1-3, selenium, zinc, phosphorus, iron, cooper, selenium- small Big; vitamin C, A, D, E, Ca, Mg
FDA two part claimer
vthat the statement has not been evaluated by FDA and that the product is not intended to "diagnose, treat, cure or prevent any disease.
Risky Products
weigh loss, treatments for Life-Threatening diseases Treat. for autism and behavioral disorders treatment for mental retardation and down syndrome colloidal minerals and silver products supplements for smokers and drinkers,
In 1976, Congress passed the Proxmire Amendments
which prevented FDA from establishing a standard limiting vitamins and minerals in nutritional supplements and nullified the agency's authority to classify a vitamin or mineral product as a drug based solely on its potency.
Where do herbs come from?
wild crafting: picking or poaching of plants, wrong plant could be toxic Farming: domestic or international; organic or convectional
