Welcome to the Supply Network Market Quickstart Program

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Rachel Byrd
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1 Welcome to the Supply Network Market Quickstart Program

2 Exhibitor & Advertising Standards

3 Unique & Free New Hope is the only media company in the natural products industry that has a dedicated Exhibitor & Advertising Standards Department

4 We Help You! We Are Your Friends

5 Started in 1994 The Standards program was developed in 1994 as a proactive, education response to the Dietary Supplement Health and Act (DSHEA).

6 Full-Time Staff The Standards Department is in-house and independent. We are staffed with 3 full-time employees and have access to many industry consultants.

7 Industry Self-Regulation Our goal is to support industry selfregulation. We help ensure accuracy of information about products that are promoted at our trade shows, in our publications, and on our websites.

8 Contractual All exhibitor and advertiser contracts require compliance with the Standards. This allows us to determine the eligibility of any company or product to be exhibited or advertised.

9 Reviews We review all exhibitor marketing materials and advertising to determine if they are compliant with the Standards. The Standards are consistent with industry and U.S. regulations.

10 Standards Focus 1. Product Safety 2. Product Claims 3. Product Labeling 4. Product Ingredients 5. Product Literature

11 Exhibitor Reviews Guided by FDA regulations New Exhibitor Application: Labeling is reviewed through the application process. Post-Expo Review: Marketing is collected from all exhibitor booths and reviewed for compliance after every trade show.

12 Advertising Reviews Guided by FTC policies Advertisements are reviewed as they are submitted to our production team. Turn-around time from receipt to a revised ad is generally 1 to 5 business days.

must be removed or revised to exhibit or advertise. 3.

13 Standards Review Process 1. Labeling (packaging, marketing and signs) are submitted to Standards and reviewed. 2. Non-compliant claims: Client is notified about the claims that must be removed or revised to exhibit or advertise. 3. Examples and suggestions of acceptable structure or function claims are sent. 4. FDA Warning Letter examples and a regulatory consultant list may be sent.

14 Focus on Claims Due to the amount of material we receive, we are limited and cannot always do in-depth reviews. Therefore a primary focus is on product claims.

15 First Point of Interaction Standards is often on the first point of interaction when we receive interesting products. We see many products that: 1. Cannot substantiate label claims 2. Make unacceptable drug claims 3. Are illegal drugs

16 Lollipop? Text AIDS, ADHD, Depression, Asthma, Arthritis, Migraines, Nail biting...

17 Contains antibodies which may help to fight against serious diseases like cancer, HIV/AIDS, Alzheimer's and Hepatitis B. Camel milk therapy helps to control diabetes. Camel Milk?

18 Cosmetic? Topical products are cosmetics unless they contain an FDA-approved OTC active ingredient.

19 Homeopathic? Homeopathic products are OTC drugs, but they cannot make claims to treat serious illness or disease.

20 Breast Enlargement chewing gum. Experience growth as fast as 30 days. No prescription needed. Larger, fuller, firmer. More than 13 unique herbs Gum?

21 FDA Enforcement Examples from BioSan Labs (GMPs) - Premium Gold Flax (disease claims) - CytoSport Inc. (misbranded) - UAS Laboratories (product seizure) - Derma Remedies (FDA and FTC Warning)

22 BioSan Laboratories - June 17, 2011 Adulterated Dietary Supplements The inspection revealed the following violations: 1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. 5. Your firm failed to make and keep documentation of any material review and follow-up.

BioSan Laboratories - continued Misbranded Dietary Supplements 3. Your Adrenal Refresh dietary supplement is misbranded in that the label fails to identify the part of the plant (e.g.

23 BioSan Laboratories - continued Misbranded Dietary Supplements 3. Your Adrenal Refresh dietary supplement is misbranded in that the label fails to identify the part of the plant (e.g., root, leaves) from which botanical dietary ingredients in the product is derived. 4. Your product Adrenal Refresh dietary supplement is misbranded in that the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.

Premium Gold Flax July 1, 2011 Unapproved New Drugs

addresses www.premiumgoldflax.com andwww.flaxhulllignan.

promoted for conditions that cause the products to be

The therapeutic claims on your websites establish that

24 Premium Gold Flax July 1, 2011 Unapproved New Drugs Based on claims made on your websites at the Internet addresses andwww.flaxhulllignan.co m, FDA has determined that your flaxseed products are promoted for conditions that cause the products to be drugs. The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

25 From premiumgoldflax.com: On a webpage entitled "Flaxseed in the News": An article entitled "Flaxseed Protects Against Cancer, Diabetes" "Flaxseed is Rich in Omega-3 Fatty Acids: Omega-3 fatty acids are a key force against inflammation... Evidence shows that inflammation plays a part in... heart disease, arthritis, asthma, diabetes, and even some cancers. "Flaxseed Lowers High Cholesterol..."

26 CytoSport - June 29, 2011 Misbranded Products These product labels prominently feature the word MILK, however these products contain no milk. The actual statements of identity, Protein Nutrition Shake and Nutritional Shake are in significantly smaller and less prominent type than the words MUSCLE MILK on these product labels. These product labels include the statement "Contains No Milk" on the principal display panel; however, according to the ingredient statements, these products contain the following milk-derived ingredients: calcium and sodium caseinate, milk protein isolate, and whey.

The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder,

27 UAS Laboratories June 7, 2011 Products Seized U.S. Marshals, at the request of the FDA, seized probiotic products from UAS Laboratories because the company markets the products as drugs. The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms. UAS Laboratories said the products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol.

28 Derma Remedies April 28, 2011 FDA and FTC joint Warning Letter This letter is to advise you that the FDA and Federal Trade Commission (FTC) reviewed FDA has determined your firm's marketing of the products H-Stop Dx, H- Guard Dx, Molluscum Dx, and Wart Dx are unapproved new drugs. "Herpes Treatment, Natural Genital Herpes Medication "Guaranteed Herpes Treatment with H-Stop Dx" "Herpes Prevention with H-Guard Dx" "Derma Remedies has a proven effective formula which is guaranteed to get rid of your herpes outbreak completely!"

FTC Enforcement Examples from 2008-2011 - Nivia Skin Cream (slimming claims) - NBTY (children s vitamin

29 FTC Enforcement Examples from Nivia Skin Cream (slimming claims) - NBTY (children s vitamin claims) - Kinoki Detox Foot Pads (disease claims) - Airborne (cold-and-flu claims) - Rite-Aid (cold-and-flu claims)

30 June 29, 2011 FTC Prohibits Claims that Nivea Skin Cream Can Help Consumers Slim Down Beiersdorf, Inc. to Pay $900,000 Falsely claimed that Nivea My Silhouette! cream could help consumers lose weight. Beiersdorf is one of the largest sellers of hand and body care skin cream in the United States.

31 December 13, 2010 FTC Settlement Prohibits Children's Vitamins Deceptive Health Claims about Brain and Eye Development NBTY Must Pay $2.1 Million to Refund Purchasers of Disney- and Marvel Heroes- Licensed Vitamins

32 Novemer 4, 2010 At FTC s Request, Judge Imposes Ban on Marketers of Detox Foot Pads Kinoki Advertising Claimed Pads Could Treat Medical Conditions Defendants falsely claimed to have scientific proof that the foot pads removed toxic materials from the body.

33 August 14, 2008 Airborne Agreement with FTC Brings Total Settlement Funds to $30 Million Consumers Apply for Refunds Prohibit the defendants from making false and unsubstantiated cold prevention, germ-fighting, and efficacy claims.

34 July 13, 2009 Rite Aid to Pay $500,000 in Consumer Refunds FTC Charges Rite Aid s Cold-and-Flu Remedy Supplier with False and Deceptive Advertising Germ Defense tablets and lozenges could prevent and treat colds and the flu or reduce the severity and duration of these illnesses.

35 July 22, 2011 Biotab Nutraceuticals to pay $1.75 million Civil settlement in California court. Falsely claimed ExtenZe would enhance penis size. Biotab must refund money to consumers.

36 UNACCEPTABLE Cancer Heart disease Diabetes Arthritis Alzheimer s High cholesterol Skin disorders Infections Cold, Flu or Virus Allergies Antibiotic Obesity Chronic conditions ACCEPTABLE Healthy cell growth Heart health Healthy glucose Joint health Healthy brain function Healthy cholesterol Beautiful skin Strong immunity Strengthens immunity Healthy breathing Maintains health Assists with weight loss Minor, occasional

38 FOOD SAFETY MODERNIZATION ACT July 2011: FDA can detain food - including dietary supplement ingredients - the agency believes has been produced under insanitary or unsafe conditions or that it believes are adulterated or misbranded for up to 30 days, if needed, to keep out of the marketplace. Previously, credible evidence was required for FDA to detain products it considered contaminated or mislabeled in a way that presented a threat of serious adverse health consequences. Enforcement action such as seizure or federal injunction against distribution of the product in commerce, if necessary.

39 FOOD SAFETY MODERNIZATION ACT Second rule requires anyone importing food including supplement ingredients and animal feed into the U.S. to inform FDA if any country has refused entry to the same product. This new reporting requirement will be administered through the FDA s prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

40 Step 1: Create FDA Account Go to Follow the instructions to Create New Account Keep the Account ID and Password. Step 2: Register Food Facility Go to Select Food Facility Registration Module Login with the Account ID and Password created in Step 1. Select Foreign Facility and complete the registration. Step 3: Create Prior Notice Go to: Select Login under Prior Notice System Interface Login with the Account ID and Password from Step 1.

41 FDA and FTC Standards team maintains a cooperative relationship with FDA and FTC to better understand the shifting landscape of regulations and enforcement priorities.

42 Q&A Sessions We invite FDA and FTC compliance officials to walk the tradeshow floor. We have FDA and FTC Regulatory Seminars and question-and-answer sessions to create cooperation between industry regulators and our exhibitors.

43 Success Most clients are cooperative and support industry self-regulation. They want to successfully market their products without FDA enforcement. As a result, we keep the number of canceled booths and advertisements to a minimum but we are willing to lose revenue!

44 Title Standards department is sometimes called the revenue reduction team. But we continue to feel that our investment is worthwhile because

45 Title We believe the Standards help increase consumer confidence in products promoted in our trade shows, magazines and websites and enhance the quality of the natural products industry.

46 Thank you from the standards team We especially appreciate working with international manufacturers to help ensure the safety and integrity of natural products.

47 Steve Taormina Standards Director

Opiate Freedom Center 1/11/18

Opiate Freedom Center 1/11/18 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH FEDERAL TRADE COMMISSION AND HUMAN SERVICES BUREAU OF CONSUMER FOOD AND DRUG ADMINISTRATION PROTECTION SILVER SPRING, MD 20993