SmartScience Laboratories, Inc.
Volume 130 · 130 F.T.C. 738
deceptive advertisinghealth claimsendorsements
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SmartScience Laboratories, Inc., 130 F.T.C. 738 (2000). Consumer Law Library, https://consumerlawlibrary.org/decisions/v130-0020
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IN THE MATTER OF SMARTSCIENCE LABORATORIES, INC., ET AL. CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-3980; File No. 9923274 Complaint, November 2, 2000--Decision, November 2, 2000 This consent order addresses SmartScience’s representations for JointFlex. The complaint alleges that Respondent advertised that JointFlex eliminated significant pain due to disabling joint conditions, crushed vertebrae, arthritis, herniated disk, and other conditions and that JointFlex provided more pain relief than other over-the-counter pain creams. The complaint also alleges that Respondents ads represented that the glucosamine sulfate and chondroitin sulfate in JointFlex contribute to pain relief when applied topically, but that respondents do not possess competent and reliable evidence that the glucosamine sulfate and chondroitin sulfate in JointFlex, a topically applied cream, penetrates the skin sufficiently to induce a pharmacological effect. The consent order requires Smartscience to have competent and reliable scientific substantiation for any future claims about the comparative efficacy of JointFlex or any other drug or supplement or any ingredient therein for relieving reducing or eliminating pain, or providing health benefits. In addition, the consent order prohibits the respondent from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test or study and that the experience of any testimonialist or endorser is typical unless this conclusion is supported by competent and reliable scientific evidence. The order provides a safe harbor not prohibiting representations that permitted by a standard promulgated by the Food and Drug Administration for labeling or in a drug approval.
Participants For the Commission: Janet M. Evans, C. Lee Peeler, and BE. For the Respondents: Steven Weitzman, Smartscience Laboratories, Inc. and Gilbert Weil, Weil, Guttman & Malkin L.L.P.
SMARTSCIENCE LABORATORIES, INC., ET AL. 739 Complaint COMPLAINT The Federal Trade Commission, having reason to believe that Smartscience Laboratories, Inc., a corporation, and Gene C. Weitz, individually and as an officer of the corporation ("respondents"), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges: 1. Respondent Smartscience Laboratories, Inc. (ASmartScience@) is a Florida corporation with its principal office or place of business at 2327 Destiny Way, Odessa, Florida 33556. Smartscience was formerly known as Eden Laboratories, Inc. 2. Respondent Gene Weitz is an officer of the corporate respondent. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of the corporation, including the acts or practices alleged in this complaint. His principal office or place of business is the same as that of Smartscience.
3. Respondents have manufactured, advertised, labeled, offered for sale, sold, and distributed products to the public, including JointFlex Pain Relieving Cream (AJointFlex@). JointFlex is a "drug" within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. According to the JointFlex label, camphor (3.1%) is the product=s active ingredient. The product also contains chondroitin sulfate and glucosamine sulfate which the label identifies as inactive ingredients. 4. The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act. VOLUME 130 Complaint 5. Respondents have disseminated or have caused to be disseminated advertisements for JointFlex, including but not necessarily limited to the attached Exhibits A through E. These advertisements contain the following statements and depictions: A. A>After two crushed vertebrae followed by painful arthritis, I never thought I=d get rid of the pain, until I used JointFlex. The results were amazing!= [Picture of smiling consumer].
Men and women of all ages are amazed at the relief they are experiencing from a revolutionary new pain relief cream called JointFlex. . . . Not only are they getting rid of nagging pain, they=re enjoying the activities they love so much. According to a recent survey, a staggering 95 % said, JointFlex helped reduce their pain, often where other pain relief products failed.@ (Exhibit A--Newspaper ad run in USA Today, Dallas Morning News, Washington Post and others) B. AIs Pain Spoiling Your Fun in Life? Do What These People Did! . . . .
Men and women of all ages are amazed at the relief they are experiencing from a revolutionary new pain relief cream called JointFlex . . .
Nutrient Enriched with Glucosamine & Chondroitin Sulfate . . . .
Why put up with pain when these people got rid of theirs so easily? Theresa Carmen, an insurance broker swears by JointFlex. I used crutches because of a herniated disk in my back. After using JointFlex, I am now able to walk without crutches! I was really, REALLY surprised when I got relief in 5 minutes. It=s amazing@.
SMARTSCIENCE LABORATORIES, INC., ET AL. 741 Complaint Tried Pain Relief Creams With Little Results? Don Huffer, a man from Florida, said: ANone of the other name brand products I tried helped, only JointFlex worked.@ An 80-pound header fell on Don=s head and crushed two vertebrae. Soon afterwards, very painful arthritis set in. This is what he did. AI got two steroid injections that cost $1,000 each at the hospital. That helped the pain some but I didn=t want more injections because of the possible side effects. Then I tried JointFlex. To my utter amazement, the pain stopped! It was like a light went on in my life![@] . . . .
New technology makes the ingredients more effective in relieving pain! What makes JointFlex different from other pain relief creams? No other pain relieving cream utilizes the fast penetrating, patent pending FUSOME DELIVERY SYSTEM, and also contains the much publicized, all natural ingredients, GLUCOSAMINE & CHONDROITIN SULFATE.
A Revolutionary New Product to help Stop Pain JointFlex combines the nutrients, glucosamine and chondroitin sulfate, with it=s patent pending, Fusome Delivery System and makes the combination into a nongreasy cream that can be applied directly to painful areas. The results are astounding!@ * * * * Which symptoms do you want to eliminate? Χ Arthritis Pain Χ Simple Backache Χ Muscle Sprains Χ Tendonitis Χ Neck Pain VOLUME 130 Complaint Χ Shoulder Pain Χ Knee and Leg Pain Χ Muscle Cramps Χ Muscle Strains Χ Bruises and more (Exhibit B--Newspaper ad run in USA Today, New York Post, Los Angeles Times, Chicago Tribune, Washington Post, and others) C. Effective at Reducing Pain for People of all Ages! Sixteen year old Melissa Cirello couldn=t walk because she injured her back cheer leading. After only a few applications of JointFlex she said: AThe pain went away completely. I could start cheer leading again!@ . . . .
Do Your Favorite Activity Without Pain! Catherine Lambert played 18 holes of golf every week until her knees hurt so badly she had to stop. AI started using JointFlex and the swelling went down. I felt relief. Soon I was back to playing two rounds of golf a week. My friends said, AWhat happened to you? Did you have surgery?[@] I told them no. I started using JointFlex and now I have no pain on most days![@] (Exhibit C--Internet ad on www. jointflex.com) F. ahhh! . . .More Pain Relief! GUARANTEED! Nutrient Enriched with Glucosamine & Chondroitin Sulfate . . . .
What makes JointFlex different from other pain relief creams? No other pain relieving cream utilizes the fast penetrating, patent pending Fusome Delivery System and also contains the all natural nutrients, glucosamine and SMARTSCIENCE LABORATORIES, INC., ET AL. 743 Complaint chondroitin sulfate. This new technology makes the ingredients more effective in relieving pain. (Exhibit D--Magazine ad newspaper ad carried by Newsweek, Prevention) G. AWhy Continue to Live with Pain? JointFlex Pain Relieving Cream . . .
utilizes breakthrough delivery system technology to provide more pain relief than competitive brands! Guaranteed!@ (Exhibit E--Brochure distributed with product) 6. Through the statements and depictions described in Paragraph 5, respondents have represented, expressly or by implication, that: a. JointFlex eliminates significant pain due to disabling joint conditions, crushed vertebrae, arthritis, herniated disk, and other conditions;
b. JointFlex provides more pain relief than other over-thecounter pain creams; and c. Testimonials from consumers appearing in the advertisements for JointFlex represent the typical or ordinary experiences of members of the public who use the product.
7. Through the statements and depictions described in Paragraph 5, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 6 at the time the representations were made.
VOLUME 130 Complaint 8. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 6 at the time the representations were made. Therefore, the representation set forth in Paragraph 7 was, and is, false or misleading.
9. Through the statements and depictions described in Paragraph 5, respondents have represented, expressly or by implication, that the glucosamine sulfate and chondroitin sulfate in JointFlex contribute to pain relief when applied topically. 10. Through the statements and depictions described in Paragraph 5, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representation set forth in Paragraph 9 at the time the representation was made.
11. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representation set forth in Paragraph 9 at the time the representation was made. Among other reasons, respondents do not possess competent and reliable evidence that the glucosamine sulfate and chondroitin sulfate in JointFlex, a topically applied cream, penetrate the skin sufficiently to induce a pharmacological effect. Therefore, the representation set forth in Paragraph 10 was, and is, false or misleading.
12. Through the statements and depictions described in Paragraph 5, respondents have represented, expressly or by implication, that: a. A competent and reliable survey of JointFlex users shows that ninety-five percent experienced reduction or elimination of pain due to use of JointFlex; b. Ninety-five percent of JointFlex users who responded to a survey said that JointFlex helped reduce their pain; and c. As characterized in JointFlex advertising, certain testimonials, including but not limited to those of Melissa SMARTSCIENCE LABORATORIES, INC., ET AL. 745 Complaint Cirello and Catherine Lambert, represent the actual experience of those individuals.
13. In truth and in fact:
a. No competent and reliable survey of JointFlex users shows that ninety-five percent experienced reduction or elimination of pain due to use of JointFlex. The survey respondents relied on was not competent and reliable, because, among other reasons, responding consumers were not randomly selected. In addition, there was no assurance that any pain reduction the responding consumers reported was due to use of the product.
b. It is not the case that ninety-five percent of JointFlex users who responded to a survey said that JointFlex helped reduce their pain. The ninety-five percent figure reflects responses to the question, Ado you feel that the product helped your symptoms,@ not a question about pain relief, and the surveys also inquired into relief from stiffness, swelling, redness, and protuberances.
c. As characterized in JointFlex advertising, certain testimonials, including but not limited to those of Melissa Cirello and Catherine Lambert, do not represent the actual experience of those individuals, because, among other reasons, Ms. Cirello=s injury did not stop her from walking and Ms. Lambert=s arthritis did not stop her from playing golf.
Therefore, the representations set forth in Paragraph 12 were, and are, false or misleading.
14. The acts and practices of respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in VOLUME 130 Complaint Exhibits violation of Sections 5(a) and 12 of the Federal Trade Commission Act.
THEREFORE, the Federal Trade Commission this second day of November, 2000, has issued this complaint against respondents.
By the Commission.
Complaint Exhibits SMARTSCIENCE LABORATORIES, INC., ET AL. TAT Complaint Exhibits Is Pain Spoiling Your Fun in Life? : Do What These People Did! ,,,, | Men and women of all ages are _ because of the possible side \ _ Which symptoms effects. Then I tried JointFlex. E | amazed at the relief they are do you want To my utter amazement. the pain stopped! It was like a light went | experiencing from a revolutionary to eliminate? on in my life! new pain relief cream called _ * Arthritis Pain | JointFlex, an FDA compliant and ¢ Simple Backache | registered nonprescription drug.
"Not only are they getting rid o nagging pain, they are once .
| enjoying the activities they Tove in relieving pain! | a Rare . so much. NOW What makes | Shoulder Pain * Knee and Leg Pain . © Muscle Cramps * Muscle Strains No other pain * Bruises and more relieving cream Just apply JointFlex to the painful utilizes the fast penetrating, patent | areas. Its fast penetrating formula pending, FUSOME DELIVERY | S0es right to work to relieve the , SYSTEM, and also contains the |; pain. There ‘J no. greasy feel, or to a consume: much publicized, all natural | pungent medication smell. | survey, a staggering 95% said nutrients, GLUCOSAMINE & | Do Your Favorite Activity JointFlex helped red CHONDROITIN SULFATE. | Without Pain! * | eliminate then } A Revolutionary New | Cathrine Lambert ed! | Product to help Stop Pain| played two rounds | Why put up with when | JointFlex combines the nutrients, | (18 holes) of golf | these people got theirs | glucosamine and chondroitin | every week until 50 easily? of sulfate, with it's patent pending, | the osteo arthritis | . , | Fusome Delivery System and | in her knees hurt Theresa Carmen, an insurance makes the combination into a | sob adly, she had: _ | broker swears by JointFlex. L used . " : — crutches because of a herniated applied divectly to nat ea be | to stop. "I started using JointFlex Taint ieee ne abr ee wank] The results are astounding! Halt relict Soon tos on Without crutches! Eenctive at Felieving Pain | Dlaving two rounds of golf a week. 1 was really, REALLY. surprised | 20* People of any Age! stlo | My-friends said, "What happened when I got reliefin 5 minutes. Sixteen year old Melissa Cirello | to vou? Did vou have surgery?" I Nutrient way Enriched with Glucosami It's amusing”. Fee ee walk because she injured | told them no, I started using Tried Pain R f er back practicing cheer leading. | JoinePlex and [now have no pain Wi rtghys R Li cre After only a few applications of |! Jointfle = t es JointFlex, she said: "The pain ae pan | went away completely. | could powil have your won Success story! lone 79) Pa of the other MANUFACTURER COUPON | EXPIRES 2/29/00 Nye ies! Saves2.00 "= ake i oroducts | TM On One doz. size tube - ' te tried helped. only JointFlex . eae = it an nyt tee worked". An 80-pound header fell Y: ~— on Don's head and crushed two + vertebrae. Soon afterwards, very ! painful arthritis set in. This is what« he did. "I got two steroid injections! ; nna: ] that cost $1,000 each at the ‘ : ~ hospital. That hel in ‘ . . .
SPMCR EGET OAT BMagg gE 11004 Start cheer leading again".
e VOLUME 130 Complaint Exhibits SMARTSCIENCE LABORATORIES, INC., ET AL. 749 Complaint Exhibits some TR TE ee ' ede? ; Complaint Exhibit D J Oo0ool:
ws More Pain Relief! Enniched with GUARANTEED! Glucosamine & Chondroitin os .. If you have tried other pain relieving creams amazed at the reli Me without results, you should try JointFlex. they are experiencin: e& After all, with its' money back guarantee, from a revolutionary . you have nothing to lose but the pain. new pain relief cream . JointFlex, with its revolutionary © called JointFlex, an FDA Fusome Delivery S hasa compliant and registered 4X pleasant, nonm: odor, is nonprescription drug.
Now, you too can get rid of y nagging pain and enjoy the activities you love so much.
According to a recent survey, a staggering 95% said JointFlex helped reduce or eliminate their pain, often where other pa . Your pain relieving products failed! * é will reduce... What makes JointFlex different from other pain relief creams? No other pain LY >. ONEY BACK! relieving cream utilizes the fast penetrating, patent pending Fusome Delivery System Questions Asked. and also contains the all natural nutrients," ‘Rid Of Your Pain... NOW! jucosamine and chondroitin sulfate. YY ~ ieee eee 1-800-340-5603 more effective in relieving pain Which symptoms do NOT SOLD IN STORES +1 you want to eliminate? Use VISA. Mastercard, Discover or American Express. You can try JointFlex in the privacy of your own home, at no risk to you. Order by phone NOW. As soon as it arrives, try it and see if your pain doesn't ! reduce or disappear. If you're not amazed with the results, just retum the remainder back to us for Faye: a full refund, no questions asked. One large four ° Knee and Leg Pain ounce tube is Only $19.95, plus shipping and . Muscle Strains {ae D handling. A small price to pay for more pain telief. ‘* Bruises and more FDA Drug Registration No. - NDC 64479-110-04 LABORATORIES, INC.
ones JointFlex and Fusome are trademarks of Eden Laboratories. Inc. Arthritis Pain Simple Backache Muscle Sprains VOLUME 130 Complaint Exhibits SMARTSCIENCE LABORATORIES, INC., ET AL. 751 FUSOME™ Deep Release System JointFlex™ Pain Relieving Cream's advantage lies in the cutting edge dermal (to the skin) delivery system, Eden's unique, patent-pending FUSOME™ delivery system effectively delivers the FDA compliant and registered pain relieving formula directly to your problem areas, The FUSOME™ Deep Release System is a novel combination of the latest advancements in emulsification and skin penetration technology.
Ingredients are quickly and safely delivered to the skin enhancing their inherent benefits.
The FUSOME™ Deep Release System provides fast, deep penetration enabling long lasting rellef from minor arthritis pain, simple backache, bursitis, tendonitis, muscle strains and sprains, bruises and cramps.
Only JointFlex™ Pain Relieving Cream utilizes this revolutionary break-through FUSOME™ delivery system technology, Complaint Exhibits i) JointFlex . i ic} Pain Relieving Cream Provides temporary relief from minor arthritis pain, simple backache, bursitis, tendonitis, muscle strains and sprains, bruises and cramps.
FDA Compliant and Registered Nonlrescriplion Drug * (tilizes Patent-Pending FUSOME™ Delivery System Technology * fast Absorbing, Non-Greasy * Contains Natural Essential Nutricnts - Glucosamine and Chondroitin Sulfate #Non-Stinging, Non-Burning + Mild Camphor Scent Dissipaics Quickly *GUARANTEED Performance or your money back Won'til be great PR, to enjoy ~ . YOU favorite 1 activities with little orno PAIN? Directions: Cleanse, rinse and dry shin prior io application.” Apply generously to patnyiul muscles and Joints and gently massage itil the JointFlex™ Pain Relieving Cream disappears. Repeat as necessary. Far ‘uptimunr benefit, ese twice daily fora minimum of two weeks, See label for additional Information, [tried other brand-name products to gain reliel, Nothing worked until [tried JoiniFlex* [went toa hospital and got two steruid injections that cost $1,000 each. That helped the pain some but I didn't want more injections because of the possible side effects. Then [tried JointFlex™. To my utter amazement, the pain stopped! Before using it, [could hardly ura my head. Now I have almost 10U% range of motion. It is like somebody switched a new lighton in my life” « Don.
“Before using JointFlex | had a hard time getting in and out of my car. [couldn't lift my foot past my ankle because of the pain, Nothing I tried worked. |applied JointFlex™ and couldn't believe it when the pain reduced. Now | ean lift my foot to my knee...oo pain, [can get in and out of my car, .nu pain. Now | can walk, ride my bike and finally get a good night's rest because of the reduced pain."
Jim "Alter applications of JointFlex™ the pain wentaway Not only was Table to walk again, 1 could participate in my cheer leading competition again without any pain.”
+ Melissa.
When | put on JointFlex™ | can go into restaurants and other places. People don't know I'm wearing pain cream - like they might with some other products - because there's no medication smell,”
Larry ¥ VOLUME 130 Decision and Order DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the respondents named in the caption hereof, and the respondents having been furnished thereafter with a copy of a draft of complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondents with violations of the Federal Trade Commission Act; and The respondents, their attorney, and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by the respondents of all the jurisdictional facts set forth in the aforesaid draft of complaint, a statement that the signing of said agreement is for settlement purposes only and does not constitute an admission by respondents that the law has been violated as alleged in such complaint, and waivers and other provisions as required by the Commission's Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the respondents have violated the said Act, and that a complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of thirty (30) days for the receipt and consideration of public comments, now in further conformity with the procedure described in Commission Rule 2.34, 16 C.F.R. ' 2.34, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order:
1. Respondent Smartscience Laboratories, Inc. is a corporation organized, existing and doing business under and by virtue of the laws of the State of Florida. The mailing address and principal place of business of Smartscience Laboratories, Inc. is 2327 Destiny Way, Odessa, Florida 33556. SMARTSCIENCE LABORATORIES, INC., ET AL. 753 Decision and Order 2. Respondent Gene Weitz is an officer or director of the corporate respondent. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of the corporate respondent, including the acts or practices alleged in the complaint. His principal office or place of business is the same as that of Smartscience Laboratories, Inc. 3. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondents, and the proceeding is in the public interest.
ORDER DEFINITIONS For purposes of this order, the following definitions shall apply:
1. ACompetent and reliable scientific evidence" shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. 2. Unless otherwise specified, "respondents" shall mean Smartscience Laboratories, Inc., a corporation, its successors and assigns and their officers; Gene C. Weitz, individually and as an officer of the corporation; and each of the above=s agents, representatives, and employees.
3. "Commerce" shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. ' 44.
VOLUME 130 Decision and Order I.
IT IS ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of JointFlex Pain Relieving Cream or any dietary supplement or drug, as "drug" is defined in Section 15 of the Federal Trade Commission Act, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, about:
A. The absolute or comparative efficacy of the product in reducing, relieving, or eliminating pain from any source; B. The health benefits, performance, safety or efficacy of any such product; or C. The ability of glucosamine sulfate, chondroitin sulfate, or any other ingredient to relieve pain or provide any other health benefit when applied topically;
unless, at the time of making such representation, respondent possesses and relies upon competent and reliable scientific evidence that substantiates the representation. II.
IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any product in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, survey, or research.
SMARTSCIENCE LABORATORIES, INC., ET AL. 755 Decision and Order III.
IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any product in or affecting commerce:
A. Shall not misrepresent, in any manner, expressly or by implication, that any user testimonial or endorsement of the product reflects the actual and current opinions, findings, beliefs, or experiences of the user; and B. Shall not represent, in any manner, expressly or by implication, that the experience represented by any user testimonial or endorsement of the product represents the typical or ordinary experience of members of the public who use the product, unless:
i. At the time it is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation; or ii. Respondents disclose, clearly and conspicuously, and in close proximity to the endorsement or testimonial, either what the generally expected results would be for users of the product, or the limited applicability of the endorser's experience to what consumers may generally expect to achieve, that is, that consumers should not expect to experience similar results.
For purposes of this Part, "endorsement" shall mean as defined in 16 C.F.R. ' 255.0(b).
VOLUME 130 Decision and Order IV.
Nothing in this order shall prohibit respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration. V.
Nothing in this order shall prohibit respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.
VI.
IT IS FURTHER ORDERED that respondents Smartscience Laboratories, Inc., it successors and assigns, and respondent Gene Weitz shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon request make available to the Federal Trade Commission for inspection and copying: A. All advertisements and promotional materials containing the representation;
B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations. SMARTSCIENCE LABORATORIES, INC., ET AL. 757 Decision and Order VII.
IT IS FURTHER ORDERED that respondents Smartscience Laboratories, Inc., and its successors and assigns, and respondent Gene Weitz shall deliver a copy of this order to all current and future principals, officers, directors, and managers, and to all current and future employees, agents, and representatives having responsibilities with respect to the subject matter of this order, and shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to current personnel within thirty (30) days after the date of service of this order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities.
VIII.
IT IS FURTHER ORDERED that respondent Smartscience Laboratories, Inc. and its successors and assigns shall notify the Commission at least thirty (30) days prior to any change in the corporation(s) that may affect compliance obligations arising under this order, including but not limited to a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor corporation; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the corporate name or address. Provided, however, that, with respect to any proposed change in the corporation about which respondent learns less than thirty (30) days prior to the date such action is to take place, respondent shall notify the Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580, Attn: Smartscience Laboratories, Inc.
VOLUME 130 Decision and Order IX.
IT IS FURTHER ORDERED that respondent Gene Weitz, for a period of ten (10) years after the date of issuance of this order, shall notify the Commission of the discontinuance of his current business or employment, or of his affiliation with any new business or employment. The notice shall include respondent's new business address and telephone number and a description of the nature of the business or employment and his duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580, Attn: Smartscience Laboratories, Inc.
X.
IT IS FURTHER ORDERED that respondent Smartscience Laboratories, Inc., and its successors and assigns, and respondent Gene Weitz shall, within sixty (60) days after the date of service of this order, and at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with this order.
XI.
This order will terminate on November 2, 2020, or twenty (20) years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: A. Any Part in this order that terminates in less than twenty (20) years;
B. This order's application to any respondent that is not named as a defendant in such complaint; and SMARTSCIENCE LABORATORIES, INC., ET AL. 759 Analysis to Aid Public Comment C. This order if such complaint is filed after the order has terminated pursuant to this Part.
Provided, further, that if such complaint is dismissed or a federal court rules that the respondent did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that the order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. By the Commission.
Analysis of Proposed Consent Order to Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from Smartscience Laboratories, Inc. and its president, Gene Weitz, (together, ASSL@) settling charges that they engaged in a largescale deceptive advertising campaign for JointFlex, a skin cream. The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
This matter involves alleged misleading representations for JointFlex. Respondents sold this cream through advertisements in national newspapers and magazines (including USA Today, the VOLUME 130 Analysis to Aid Public Comment Washington Post, and Newsweek), more than 200 other major and minor local newspapers, and two websites that are not currently operative. According to the FTC complaint, SSL advertisements represented that JointFlex eliminates significant pain due to disabling joint conditions, crushed vertebrae, arthritis, herniated disk, and other conditions; that JointFlex provides more pain relief than other over-the-counter pain creams; and that testimonials from consumers appearing in the advertisements for JointFlex represent the typical or ordinary experiences of members of the public who use the product. According to the complaint, SSL lacked a reasonable basis to substantiate these claims. The complaint also alleges that respondents ads represented that the glucosamine sulfate and chondroitin sulfate in JointFlex contribute to pain relief when applied topically, but that respondents do not possess competent and reliable evidence that the glucosamine sulfate and chondroitin sulfate in JointFlex, a topically applied cream, penetrates the skin sufficiently to induce a pharmacological effect.
The complaint further alleges that SSL made several false advertising claims. It alleges that the ads represented that a competent and reliable survey of JointFlex users shows that ninety-five percent experienced reduction or elimination of pain due to use of JointFlex. This claim is alleged to be false because the survey respondents relied on was not competent and reliable, because there is no assurance that any pain reduction the responding consumers reported was due to use of the product, and because the ninety-five percent figure reflects responses to the question, Ado you feel that the product helped your symptoms,@ not a question about pain relief, and the surveys also inquired into relief from stiffness, swelling, redness, and protuberances. The complaint alleges that SSL falsely characterized the results of certain testimonials, by overstating the nature of their injuries at the time they used the JointFlex product. The proposed consent order contains provisions designed to prevent respondents from engaging in similar acts and practices in the future. Part I of the order would require, with regard to JointFlex or any drug or supplement, competent and reliable SMARTSCIENCE LABORATORIES, INC., ET AL. 761 Analysis to Aid Public Comment scientific substantiation for future claims about the absolute or comparative efficacy of the product in reducing, relieving, or eliminating pain from any source; the health benefits, performance, safety or efficacy of any such product; or the ability of glucosamine sulfate, chondroitin sulfate, or any other ingredient to relieve pain or provide any other health benefit when applied topically.
Part II prohibits respondents, in connection with any product, from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, survey, or research.
Part III provides that, in connection with any product, respondents shall not misrepresent the experience of any testimonialist or endorser. It further provides that respondents shall not represent that the experience represented by any user testimonial or endorsement of the product represents the typical or ordinary experience of members of the public who use the product, unless the typicality claim is substantiated by competent and reliable scientific evidence; or respondents disclose, clearly and conspicuously, and in close proximity to the endorsement or testimonial, either what the generally expected results would be for users of the product, or the limited applicability of the endorser's experience to what consumers may generally expect to achieve, that is, that consumers should not expect to experience similar results.
Part IV of the order is a safe harbor, providing that the order does not prohibit respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration. Part V is a safe harbor, providing that the order does not prohibit respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated VOLUME 130 Analysis to Aid Public Comment by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.
Parts VI-XI are standard record keeping, order distribution, reporting, compliance, and sunsetting provisions. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.
MANHEIM AUCTIONS, INC., ET AL. 763 Complaint