imported herbal remedies, dietary The global market for herbal remedies stands at over 2004 as an ingredient in remedies and herbal supplements …
IS SNAKE OIL AN UNAPPROVED DRUG?
What Wh t NJ R i t d E i Registered Environmental tl Health Inspectors/Specialists Need to Know About Imported Herbal Remedies, Dietary Supplements, and Cosmetics
Virginia M Wheatley, MPH Research Scientist 2 Food and Drug Safety Program NJDHSS 609588 3123 609588-3123 virginiawheatley@dohstatenjus
What Is Snake Wh t I S k Oil?
A pain reliever that originates from i li h ii f China, and was popularized in classic American film Snake oil has became film Snake oil a generic name for many compounds marketed as miraculous remedies In US, ingredients were usually secret, unidentified, or mis-characterized — and mostly ineffective
2
Modern Snake Oil?
Roghan Badam Shirin Sweet Almond Oil label claims: relieves tension strengthens brain power good for heart relieves constipation fights dandruff keeps body warm in winter nourishes skin i h ki prenatal/postnatal care helps build stronger bones good for infants
3
Objective j
After viewing this
presentation, you will gain a better understanding of: Popularity of imported herbal remedies, dietary supplements, supplements and cosmetics Cultural roots Significant health issues Routes of entry into the US Where to find the products FDA regulation, NJ statutes and rules, limitations Steps to take when you find such products during an inspection i ti
4
Globalization
Increased consumer demand for quality, variety, freshness variety freshness, price Increased innovations in transportation Products moving more rapidly Larger quantities of products
Port Newark, NJ
Growing ethnic populations li
Billions of foreign or foreign-made products routinely enter the US particularly NJ/NY due ill d to extensive ports
Increase in international commerce
5
Uses of Herbal and Dietary Products
Prevent illness/disease or manage symptoms
Weight control Boost energy and increase vitality I Increase l longevity it Improve mental or physical performance Alternative to more expensive
treatments
6
Cultural Roots
Deep roots in mystical/spiritual beliefs and ancient traditions: In India, Ayurvedic, or knowledge of life medicine is stated to be a divine revelation of the ancient Indian creator, Brahma Also, Unani, Siddha In China, holistic medicine includes the theory of Ying-Yang, the vital force of life Qi, and the five elements of natural energies Metal, Wood, Water, Fire, and Earth d E th
7
Some Interesting Facts g
50 of Europeans, North Americans, and people from other industrialized countries have used herbal remedies at least once In China, herbal preparations account for 30-50 of the total medicinal consumption Herbal products used by 70-80 of Indias population 60 of children with malaria-induced fever receive herbal t t h b l treatment at home in some African countries t th i Af i ti
Source: World Health Organization
8
Some Interesting Facts continued
75 of people living with HIV/AIDS use herbal h b l remedies as treatment in San Francisco, di tt
ti S F i London, and South Africa 158 million adults use herbal remedies Herbal supplements for pets gaining popularity The global market for herbal remedies stands at over 60 billion annually and is growing steadily
Source: World Health Organization
9
Popularity p y
Cheaper than going to a doctor Natural, so perceived as safe/better Available for retail sale without prescription p p Proven to work because product or ingredients have been around for centuries Distrust of modern medicine Harsh treatments for life-threatening diseases But many products HAVE NOT BEEN PROVEN yp TO WORK and ARE NOT SAFE
10
Issues
1 May cause harmful, even fatal effects y y 2 Pre-market safety and efficacy testing NOT required 3 Can reduce the effectiveness of medications 4 Quality control standards to ensure consistent amount of active ingredients and purity not required - as of June 2007, q alit control standards J ne 2007 quality now required
11
Issues
According to a recent study many
people: Have no idea whether herbal remedies are effective A l Are largely ignorant of the potential health risks li t f th t ti l h lth i k More than 2/3 of supplements have NEVER been clinically proven to be effective for the specific conditions theyre advertised to ease or cure y SNAKE OIL??? Source: Mayo Clinic, June 2007
12
Safety Issues: Cosmetics
RECETA DE LA FARMACIA skin lightening cream from th Dominican Republic found in NY f the D i i R bli f di Also for acne skin blemishes freckles acne, blemishes, Contains 6,000 p , parts per million of mercury FDA p y allows 1 ppm Caused at least one case of mercury poisoning that lead to hospitalization
13
Safety Issues: Cosmetics
KOHL, KAJAL, AL-KAHL, or SURMA often contains high l d levels; found in NJ in April-May 2007 t i hi h lead l l f di i A il M In some cultures used cultures, as eye makeup for both children and adults Directly linked to blood lead poisoning Unapproved color additive; illegal to sell in the
US
14
NOTE: kohl is often used to describe a shade of black; not an ingredient in the product Check ingredient list
Safety Issues: Supplements y pp
EPHEDRA aka, ma huang - Banned for sale since 2004 as an ingredient in remedies and herbal supplements Derived from an Asian shrub For energy and weight loss Presents unreasonable risk, especially to those with heart disease, high BP Caused 16,000 adverse health events 16 000 including 150 deaths
2003: 23-year old Baltimore Orioles pitcher, Steve Bechler, Bechler died from Ephedra-related complications
15
11/5/07: Metabolife International founder Michael Ellis pleaded guilty to making false statements when he told FDA in 1999 that his firm had not received any reports of adverse events linked to ephedra fd t li k d t hd
Michael Ellis
In fact, Metabolife had received THOUSANDS of such reports p Not revealed until 2002, this led to the ban of ephedra and mandatory adverse event reporting d i
Source: Food Chemical News,
2007
16
Safety Issues: Supplements y pp
SAFI BLOOD PURIFIER Indian herbal product found in NJ in April-May 2007 April May Promoted for acne, boils, rashes, blemishes Claims to cure constipation, check nose bleeding, correct indigestion, improve complexion li Confusing wordage builds sturdy babies is actually an ad for another product BUTIT CONTAINS MORE THAN 40 TIMES THE ALLOWABLE AMOUNT OF ARSENIC
17
Safety Issues: Supplements
LU SHEN WAN Chinese herbal medicine found for OTC sale in NJ in June 2007 li iJ Claims to treat respiratory conditions and various toxic heat problems Contains chan su, herbal ingredient that has caused cardiac arrythmia, breathlessness, seizure, coma, one death Chan su not listed on label
18
Are ALL Herbal Remedies/Dietary Supplements Bad?
NO In fact, 25 of modern medicines are made from plants first used traditionally Artesmia annua, a Chinese herbal remedy, proven to be an effective malaria treatment In South Africa, a plant used to treat AIDS
patients may increase p y patients energy, appetite, body mass gy, pp , y Folic acid known to reduce birth defects when taken by pregnant women
19
Are ALL Herbal Remedies/Dietary Supplements Bad?
Mistletoe proven to kill cancer cells, stimulate immune system Hawthorn leaf and flower safe and effective for mild heart failure Grape seed prevents cell damage caused by free radicals
Source: National Center for Complementary and Alternative Medicine, NIH, 2007
20
How Are Products Getting Here? g
Internet sales, air mail shipments, smuggling Weak US regulation Grey markets a disease to be eradicated y
Sources: MIT Sloan Management Review, i 2004; Journal of Marketing, 2006
21
FDA Regulation: DSHEA g
Until 1994, FDA regulated dietary supplements as food under the Food, Drug, Cosmetic Act In 1994, new legislation was passed THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT DSHEA SIGNIFICANCE: unlike new food ingredients and drugs, dietary supplements and their ingredients are no
longer pre-approved by the FDA FDAs l is FDA role i reactive, not pro-active ti t ti
22
Gaps in DSHEA Regulation
Manufacturers are responsible for ensuring: - product safety and efficacy d t ft d ffi - truthful labeling - reporting of adverse events Onus on FDA to prove product is unsafe
23
FDA Regulation: CGMPs
Effective August 24, 2007: FDA announced Interim Final Rule IFM, establishing regulations to require CGMPs for dietary supplements The rule ensures that they: are produced in a consistent, q p , quality manner y do not contain contaminants or impurities are accurately labeled
Let s Lets go into more detail detail
24
FDA Regulation: CGMPs
Intended to prevent: i inaccurate amounts of ingredients t t fi di t wrong ingredients contaminants improper packaging improper labeling pp g
25
FDA Regulation: CGMPs
Applies to: All domestic and foreign companies that manufacture, package, label package label, or hold dietary supplements
26
FDA Regulation: CGMPs
The
rule establishes CGMPs that require dietary supplements to be manufactured consistently as to: l ttb ft d i t tl t identity purity strength g composition
27
FDA Regulation: CGMPs
Provisions: design and construction of plants cleaning proper manufacturing operations quality control p q y procedures testing final product or ingredients handling consumer complaints maintaining records
28
FDA Regulation: CGMPs
Three-year phase-in: J June 2008 l 2008: large companies i June 2009: medium-sized companies with 500 employees June 2010: small companies with 20 employees
June 2008 J June 2009 June 2010
29
FDA Regulation: CGMPs
Manufacturer requirements: qualified employees lifi d l plant design protects product from adulteration equipment/utensils are appropriate for intended use manufacturing and batch production records are established and maintained quality control established product and ingredients held/distributed under good environmental and sanitary conditions
record of complaints file of records 1 year past shelf life or 2 years past last batch distribution date
30
So What?
The burden of proof regarding safety and efficacy of a p product is still on the manufacturer
Numerous products manufactured cheaply in other
countries where conditions may be questionable Such products enter into the US everyday Demand is increasing
FDA inspects LESS THAN 1 of all imported products under its jurisdiction
31
So What?
Many products that enter into the US market contain active ingredients not listed on label concern: allergens, drug interactions Products safe for healthy persons may not be safe for pregnant women or someone with serious illness
The FDA banned these products in the US because they have drug ingredients that are not listed li d on the l b l h label
Medimix soap India Kelly Pearl cream China
32
So What?
Sweeping claims that are false, unproven, and/or not approved by the FDA ie, controls diabetes Gi false hope to desperate
people; may delay Give f l h td t l dl necessary treatment Exclusive reliance on herbal medicine
NJDHSS inspectors recently embargoed y g Dia-Slim Tumbler, a diabetes control treatment made in India It is an unapproved product CLAIMS: controls diabetes reduces excessive fat controls blood sugar purifies blood
33
These claims are not approved by the FDA, so the product is unapproved
So What?
Numerous imported products have non-English labels Consumers who do not read the language miss out on important health information
Labels must be written in English Foreign language translations are permissible, as long as all required labeling is in English
34
So What?
Lack of adequate oversight potential for environmental contaminants Contaminants from cultivation, formulation, contaminated machinery Found in numerous herbal products from China and India: - pesticides - heavy metals cadmium, mercury, lead, arsenic - highly toxic alkaloids
35
If industry self-regulates and FDA
self regulates inspects 1 of imported products
whos the REAL watch dog?
36
37
If YOU found these products during an inspection
would YOU would know what to do?
38
FDA Regulation g
Under the Food, Drug, Cosmetic Act, all imported products must be: pure, wholesome, safe to eat food produced under sanitary conditions safe and effective drugs and devices safe and made from approved ingredients cosmetics and must contain informative and truthful labeling in English Products that DO NOT conform to these standards are either adulterated or misbranded ith d lt t d ib dd
39
What s Whats the Difference?
As defined in the US FDC Act: Adulteration refers to the content of a product such as the addition of a substance which makes a product h ddi i f b hi h k d inferior, impure, not genuine, etc Misbranding refers to statements on labels or labeling that are false or misleading g
40
How Does NJ Regulate Herbal Medicine/Dietary Supplements and Cosmetics?
Its simple Our rules
reference FDA regulations and we follow FDA guidance
41
What to Look For
PREVENT, TREAT, CURE, REMEDY
HEALTH CONDITION
or contains an active ingredient
PRODUCT MAY BE CONSIDERED AN UNAPPROVED DRUG
Under NJAC 8:21, New Jersey references FDA regulatory requirements for Under labeling Use these citations for violations: For dietary supplements and unapproved drugs, NJSA 24:1-1 and NJAC 8:21-12, 1 3 N J A C 8:21-1 2 13, and 1 4 14 For cosmetics, NJSA 24:1-1 and NJAC 8:21-12 and 15
42
Actual Claims Refused by FDA
Used for dyspnea with shortness of breath, acute and chronic tracheitis, and for patients in bronchial asthma , p Used for chest pain, headache, coronary heart disease, angina pectoris, hypertension gp , yp Indication: dizziness due to tinnitus and otalgia, dysuria dysuria It is usually used to treat cystitis, urethriris, kidney stone and syndrome of strangury strangury painful urination
Source: FDA Cyber Warning Letter - April 8, 2004
43
What to Look For
Definition of a
drug per FDC drug Act 201g:
ALL drugs MUST be pre approved pre-approved for sale by the FDA
a a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease b a product other than food intended to affect the structure or any function of the body c a product that is not a cosmetic
44
What to Look For
Whats the difference between a drug and an herbal/dietary supplement? herbal/dietary supplement? Definition of a dietary supplement per FDC Act 201ff1: A dietary supplement is composed only of essential nutrients, such as vitamins, minerals, and proteins, herbs, or similar nutritional substances to include ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these
45
What to Look For
A dietary supplement can be classified as an unapproved drug if it 1 makes an drug unsubstantiated medical claim, and/or 2 contains an active ingredient ingredient
INDICATED FOR H PERTENSION TREATS DIABETS PRE ENTS DANDRUFF HITENS TEH REMED FOR
RHINITIS
46
HEALS ABRASIONS
CURES COLD S MPTOMS
What is NOT a Medical Claim?
Its OK to say: MAINTAIN, HELP, SUPPORT, PROMOTE, MAY , promotes good health and vitality for immune system support diets low in saturated fat and cholesterol may reduce the risk of heart disease helps to maintain cell integrity helps integrity studies suggest that regular consumption of calcium may reduce the risk of osteoporosis
47
What Does A Correct Label Look Like? CORRECT LABEL
Statement of identity y Net quantity of contents Proper structure-function claim Directions for use Supplement facts panel Li of ingredients List f i di Name/address of manufacturer Info above MUST be in English
Cosmetic labeling requirements are similar, except that supplement facts panel is not included
48
Statement of Identity
CORRECT LABEL
A product label must display a p py common language statement of identity
Karela Olibanum Olib
Bitter Melon Frankincense
49
Net Quantity of Contents
CORRECT LABEL
The
label must include the net quantity of contents for all ingredients Quantities must be listed in: pounds and ounces OR U S gallons, quarts, pints, or US ll i fluid ounces
50
Structure-Function Claim
Certain claims must include this disclaimer: This statement has not been evaluated by the Food and Drug Administration This p product is not intended to diagnose, treat, cure or prevent any disease Without this statement, it is an unapproved drug pp g
51
No label is permitted to claim APPROVED BY THE FDA
Supplement Nutrition Facts Panel
This is an easy way to identify a correctly labeled dietary supplement Should include: suggested serving size nutrients vitamin A, iron, etc t Percent Daily Value all other dietary ingredients in common language
CORRECT LABEL
52
List of Ingredients
Label must have ingredients in descending order of predominance FDA identifies certain Generally Recognized As Safe GRAS ingredients Examples: Niacin Vitamin A Zinc oxide For a complete list,
refer to Title 21, Chapter 1, Subpart F:
http://wwwaccessdatafdagov/scripts/cdrh/cfdo cs/cfcfr/CFRSearchcfm?CFRPart582
53
CORRECT LABEL
Name/Address of Manufacturer
Name/address of manufacturer must include f i ld street address Exception: if firm is easily located in telephone directory, street address not di t t t dd t necessary If manufacturer is outside US, must display the name/address of distributor in US
54
CORRECT LABEL
Inspection Procedure p
Use Inspection Checklist For Herbal/Dietary Supplements, see next page If you suspect the product pp pg y p p is ADULTERATED or MISBRANDED: 1 Take samples samples 2 Get addresses of the firms suppliers, buyers in the US For traceback/traceforward purposes, ask if they sell to other firms or if sales are limited to retail consumers 3 Embargo and/or voluntarily destroy 4 Contact: Virginia Wheatley NJDHSS, PO Box 369, Trenton, NJ 08625 virginiawheatley@dohstatenjus i i i h tl @d h t t j Tel: 609588-3123 Fax: 609588-3135
55
More
Information
NJDHSS, Food and Drug Safety Program: http://njgov/health/eoh/foodweb/ FDA-CFSAN: http://wwwcfsanfdagov/listhtml IBIDS: http://odsodnihgov/Health_Information/IBIDSaspx p g p Medwatch: http://wwwfdagov/medwatch/safetyhtm National Drug Code Query: http://wwwfdagov/cder/ndc/database/docs/queryndcnohtm NIH NCCAM: NIH-NCCAM: http://nccamnihgov/ Nutritiongov: wwwnutritiongov WHO: http://www who int/en http://wwwwhoint/en
56
Great Articles
all available on-line or from Virginia
Antia, K, et al 2004 Competing With Gray Markets MIT p g y Sloan Management Review, Fall Morris, C 2003 Internet Marketing of Herbal Products Journal of the American Medical Association, vol 290, no 11 Saper, R, et al 2004 Heavy Metal Content of Ayurvedic Herbal Medicine P d t Journal of the American Medical M di i Products J l fhA i M di l Association, vol 292, no 23 Trotter, R Trotter R 1990 The Cultural Parameters of Lead Poisoning: A The Medical Anthropologists View of Intervention in
Environmental Lead Exposure Environmental Health Perspectives, vol 89
57
So Is Snake Oil an Unapproved Drug?
Relieves and Cures: Headache Neuralgia Toothache Backache Swelling Sprains Sore chest, stiff joints, dislocations, h iff j i di l i cuts, and bruises and more
58
YOU DECIDE
59
Source:state.nj.us
