Brain-Pad, Inc.

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IN THE MATTER OF BRAIN-PAD, INC.

AND JOSEPH MANZO CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTION 5 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4375; File No. 122 3073 Complaint, November 15, 2012 – Decision, November 15, 2012 This consent order addresses Brain-Pad, Inc.’s advertising and promotion of mouth guards. The complaint alleges that respondents did not have a reasonable basis to represent in advertising and on packaging for their mouth guards that they reduced the risk of concussions. The complaint further alleges that the respondents made the false and misleading claim that they possessed scientific studies that proved their concussion-reduction risk claims because, in fact, they did not have such evidence. The consent order prohibits the respondents from misrepresenting that any product will reduce the risk of concussions or reduce the risk of concussions from lower jaw impacts. Participants For the Commission: Victor DeFrancis and Andrew Wone. For the Respondents: Patrick Wolfe, Jr., Zarwin, Baum, DeVito, Kaplan, Schaer & Toddy P.C.; Bridget Calhoun, Crowell & Moring LLP.

COMPLAINT The Federal Trade Commission, having reason to believe that Brain-Pad, Inc., a corporation, and Joseph Manzo, an individual (“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 Brain-Pad, Inc. (“BPI”) is a Pennsylvania corporation with its principal office or place of business at 322 Fayette Street, Conshohocken, Pennsylvania 19428. 2. Respondent Joseph Manzo is the President of BPI. Individually or in concert with others, he formulates, directs, VOLUME 154 Complaint controls, or participates in the policies, acts, or practices of BPI, including the acts or practices alleged in this complaint. His principal office or place of business is the same as that of BPI. 3. Respondents have labeled, advertised, promoted, offered for sale, sold, and distributed, throughout the United States, “Brain-Pad”-branded mouth guards (“Brain-Pad mouth guards”) to consumers. Brain-Pad mouth guards are “devices” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

4. The acts and practices of Respondents, as alleged herein, have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. 5. Respondents have disseminated or caused to be disseminated advertisements for Brain-Pad mouth guards, including, but not limited to, the attached Exhibits A through F. These advertisements contain the following statements and depictions, among others:

a. Product Packaging: Brain-Pad Pro+ (front of package) BRAIN-PAD, INC. 459 Complaint Brain-Pad Pro+ (back of package) PRO+ PROTECTION | PERFORMANCE | ENDURANCE Tested and proven to reduce risk of internal head injuries and concussions from lower jaw impacts Gel form liner molds firmly to teeth supporting entire dental arch Increases helmet safety and effectiveness Includes hard shell anti-microbial storage case $12,000 Dental Insurance Warranty , VOLUME 154 Complaint b. Product Packaging: Brain Pad LoPro+ (front of package) BRAIN-PAD, INC. 461 Complaint Brain Pad LoPro+ (back of package) The Patented BRAIN-PAD repositions & secures the lower jaw in a safety position, reducing the risk of concussions from lower jaw Impacts.

“With Other Mouthguards: With The BRAIN-PAD® F Brain.

" Injuries! -— ae | rca Sam TL ie oa Upon impact, the Lower Jaw The Patented BRAIN-PAD transmits can SLAM into the TMJ &the the impact energy away from the base of Base of the Skull ! the skull to the BRAIN-PAD ! New ‘streamline design’ Secures & Cushions lower jaw while protecting ALL teeth! IE > Inchuded for:

(NEW- LANYARD style “NON-HELMETED® of MELMETED USE | Patented " PROTECTION a PERFORMANCE " in 1 Package! System Includes:

Boiling Stick, Protective Case Warranty, Warnings, Care, i and Custom Fitting Instructions.

CAN UNLOCK * Meets & exceeds all youth, MUSCULAR POTENTIAL ! 57920°'80050"" 9 high school & Collegiate Regulations CUSHIONS TEETH ! “STRAP | STRAPLES in-one” Model ! LPPY 0615 OF VOLUME 154 Complaint c. Product Packaging: Brain-Pad Pro-Plus Junior (front of package) BRAIN-PAD, INC. 463 Complaint Brain-Pad Pro-Plus Junior (back of package) The patented BRAIN-PAD Positions, Secures & Cushions the lower jaw in a Safety Position, reducing the risk of concussions from the lower jaw slamming into the TMJ, base of the skull and brain, t Base of the Skuil! to the BRAIN-PAD ! memoneans - Only upper & lower channels can secure & stabilize Jaw Position while protecting the upper AND lower tet | can 5 Patented cLETEva! process teates a shock absorber that protects against lower NEW-LANYARD style C jaw impact concussions! Patented "PROTECTION s PERFORMANCE " in 1 Package! System Includes: _ vevecenes neon atm \e/ BLACKIGRAY PRO+PLUS, 2 Optional Straps, Storage Case, Warranty, Warnings, Care & Custom Fitting Instructions.

aa J CAN UNLOCK * Meets & exceeds all youth, 2 F LAR POTENTIAL 7920°50510'"7 high school & Collegiate Regulations VOLUME 154 Complaint d. Product Packaging: Brain-Pad LoPro Fem (front of package) BRAIN-PAD, INC.

Complaint Brain-Pad LoPro Fem (back of package) The Patented BRAIN PAD repositions & secures the lower jaw in a safety position, reducing the risk of concussions from lower jaw Impacts.

Your Brain With Your Brain With Upper Mouthguards The BRAIN-PAD Upper mouthguards can induce The Patented BRAIN-PAD transmits internal head injuries & the impact energy away from the base of limit breathing ! the skull to the BRAIN-PAD ! GET MORE AIR! — «aii the reported injuries, women lacrosse players (13.9%), reported the highest percentage of suffering a concussion during a game followed by women's soccer (11.4%)".* Temple University 10.3% 40% Department of Kinvsiology, ’ ~Phitadwtphts; Pa Usa ah 4% sy bry = Street Wiestng Gaskeeball Baseball Veloybes “ Female athletes were found to be at a greater risk for suffering concussions during games compared to male athletes ".* eystan Includes. Boiling Stick, Care, & Custom Fitfing JLAR POTENTIAL ! ISHIONS TEETH ! VOLUME 154 Complaint e. Product Packaging: Brain-Pad Double mouth guard (front of package) BRAIN-PAD, INC. 467 Complaint f. Internet Website: www.brainpads.com VIDEO: (Brain-Pad Commercial featuring Joseph Manzo) (Transcript at Exhibit A) ON SCREEN: BRAIN PAD Protective & Performance Solutions BIOMECHANICALLY TESTED REDUCES RISK OF CONCUSSIONS! For All CONTACT SPORTS (Exhibit A at 3).

* * * MALE ANNOUNCER: So much attention is now being paid to concussions, literally a confusion to the brain.

ON SCREEN: THE IMPORTANCE OF JAW POSITION MALE ANNOUNCER: And Brain Pad may be on the verge of a huge breakthrough in prevention after 15 years of hard work and belief.

(Exhibit A at 4).

* * * JOSEPH MANZO: Every time we got a school involved with it, at the end of the year, they would say, wow, man, our concussions went from nine to zero or nine to one. You know, it was just this constant feedback. My head -- we don’t play with the headaches anymore. (Exhibit A at 5).

VOLUME 154 Complaint g. Print Advertisement (Exhibit B) (BP00075) (depiction of MMA fighter and Brain-Pad mouth guard) MMA ORGANIZATIONS FIGHT CONCUSSIONS with BRAIN-PAD! h. Print Advertisement (Exhibit C) (BP00157) ‘Creates and retains’ a TMJ/Brain Safety Space protecting the TMJ AND Base of Skull & Brain Helping Coaches . . .

REDUCE CONCUSSION RISK * * * “BIO-MECHANICALLY TESTED & PROVEN”

REDUCES THE RISK OF CONCUSSIONS FROM: FACEMASK IMPACTS, CHIN CUP FORCES & DIRECT LOWER JAW IMPACTS! i. Print Advertisement (Exhibit D) (BP00131) PROTECTION & PERFORMANCE! Protects TMJ & Brain from Jaw Impacts • Reduces the risk of Concussion BRAIN-PAD, INC. 469 Complaint Only ‘Jaw Joint Protectors’ Reduce the Risk of Concussions & Internal Head Injuries.

j. Email Advertisement (Exhibit E) (BP00254 – 55) (Headline) Athletes Turn to Brain-Pad Mouth Guards for Concussion Protection * * * As Congress prepares to examine the issue of concussions in the NFL, NCAA, and high school sports for the second time on January 4, a Pennsylvania company has been successfully marketing a mouth guard device designed to protect players from the probability of a concussion caused by lower jaw impact.

* * * “We have said for years that concussions are serious injuries and should be avoided at all costs,” says Joe Manzo, President of Brain-Pad. “The devastating effects of concussions can have a lasting impact on athletes and their families. . . . When used properly, there is a 40 percent reduction of impact energy to the base of the skull, these forces can cause a concussion or knock out as boxers call it. Athletes from the NFL to the MMA and at every level from professional to local youth leagues are recognizing the significant health benefits of our Brain-Pad mouth guards to offer protection against these dangerous injuries.” k. Point of Purchase Display (Exhibit F) (BP00308) BRAIN PAD BIOMECHANICALLY TESTED:

REDUCES RISK OF CONCUSSIONS! VOLUME 154 Complaint 6. Through the means described Paragraph 5, including the statements and depictions contained in the advertisements attached as Exhibits A through F, among others, Respondents have represented, expressly or by implication, that: a. Brain-Pad mouth guards reduce the risk of concussions; and b. Brain-Pad mouth guards reduce the risk of concussions from lower jaw impacts.

7. Through the means 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.

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 means described in Paragraph 5, including the statements and depictions contained in the advertisements attached as Exhibits A through F, among others, Respondents have represented that:

a. scientific studies prove that Brain-Pad mouth guards reduce the risk of concussions; and b. scientific studies prove that Brain-Pad mouth guards reduce the risk of concussions from lower jaw impacts. 10. In truth and in fact, scientific studies do not prove that Brain-Pad mouth guards reduce the risk of concussions or reduce the risk of concussions from lower jaw impacts. Therefore, the representations set forth in Paragraph 9 were, and are, false or misleading.

11. The acts and practices of Respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and BRAIN-PAD, INC. 471 Complaint the making of false advertisements, in or affecting commerce, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

THEREFORE, the Federal Trade Commission, this fifteenth day of November, 2012, has issued this complaint against Respondents By the Commission.

VOLUME 154 Complaint Exhibit A

VOLUME 154 Complaint 1 JOSEPH MANZO: The way the product is designed 2 is that it brings the lower jaw forward about @ half a 3 millimeter in front of your upper teeth and the thickness 4 of the unit brings your jaw down, so you get this down 5 and forward motion, creating a safety space here. 6 ON SCREEN: Actual Lab Impact Test 7 JOSEPH MANZO: No matter if you're taking a direct hits, lateral hits, it's keeping -- these are the 9 strongest bones in the skull. So, a lot of that energy 10 is absorbed there and into the jaw joint protector. 11 MALE ANNOUNCER: So much attention is now being 12 paid to concussions, literally a confusion to the brain. 13 ON SCREEN: THE IMPORTANCE OF JAW POSITION 14 MALE ANNOUNCER: And Brain Pad may be on the 15 verge of a huge breakthrough in prevention after 15 years 16 of hard work and belief.

17 ON SCREEN: PROTECTION PERFORMANCE ENDURANCE 18 BRAIN PAD , 19 PROTECTION 20 Creates this:

21 BRAIN SAFETY SPACE! 22 PERFORMANCE 23 Jaw/TMJ alignment 24 promotes Strength & 25 Competitive Edge For The Record, Inc.

(301) 870-8025 - www. ftrinc.net - (800) 921-5555 to oN BRAIN-PAD, INC. 477 Complaint ENDURANCE Creates Increased Constant Breathing- EVEN WHILE CLENCHING! ON SCREEN: Joseph Manzo PRESIDENT, CEO JOSEPH MANZO: Every time we got a school involved with it, at the end of the year, they would say, wow, man, our concussions went from nine to zero or nine te one. You know, it was just this constant feedback. My head -- we don’t play with the headaches anymore. MALE ANNOUNCER: Finally, a biq breakthrough and now a breakout from Brain Pad’s humble beginning in Conshohocken.

JOSEPH MANZO: The product is available in all 500 Sports Autherity stores -- ON SCREEN: SPORTS AUTHORITY “Spring into...Sport Safety!”

Brain~Pad's 2011 Jaw-Joint Protector Mouth Guard Series Brain=Pad “Jaw-Joint Protectors” are a patented Sport Safety Technology! REDUCES Jaw Impact CONCUSSION Risk! Includes: Dental Warranty, hard-shell anti- For The Record, Inc, (301) 870-8025 - www.ftrinc.net - (800) 921-5555 VOLUME 154 Complaint 1 microbial case, optional strap & custom fitting 2 instructions 3 PROTECTION PERFORMANCE ENDURANCE 4 JOSEPH MANZO: -=- and it’s in over 1,000 5 Walmart stores.

6 ON SCREEN: BRAIN PAD advertisement 7 JOSEPH MANZO: We have at least 500 mom-and-pop 8 retailers, single brick and mortar retail outlets. E) ON SCREEN: BRAIN PAD 10 IMPACT PROTECTIVE 11 ALL AGES 12 HEADBANDS & WRISTBANDS 13 WITH IMPACT ABSORBENT INNER MATERIAL 14 YEAR-ROUND PROTECTION for ALL is SPORTS, ACTIVITIES & ALL AGES! 16 JOSEPH MANZO: So, the product is easily 17 accessible now.

18 ON SCREEN: BRAIN PAD 19 PROTECTIVE & PERFORMANCE SOLUTIONS 20 JAW-JOINT PROTECTORS 21 4322 FAYETTE STREET 22 CONSHOHOCKEN, PA 23 WWW. BRAINPADS .cCOM 24 610-397-0893 25 MALE ANNOUNCER: Brain Pad is located at 322 For The Record, Inc.

(301) 870-8025 - www. firinc.net - (800) 921-5555

VOLUME 154 Complaint 1 CERTIFICATION oF TYPIST ‘3 MATTER NUMBER: 1223015 4 CASE TITLE: _ANTI-CONCUSSION PRODUCTS _ 5 TAPING DATE: _DATE UNKNOWN 6 TRANSCRIPTION DATE: _NOVEMBER 21, 2011 7 REVISED: _JANUARY 10, 2012 8 I HEREBY CERTIFY that the transcript contained 9 herein is a fuil and accurate transcript of the tapes 10 transcribed by me on the above cause before the FEDERAL li TRADE COMMISSION to the best of my knowledge and belief. 13 DATED: JANUARY 10, 2012 . LG 16 ELIZABETH M. FARRELL 18 CERTIFICATION OF PROOFREADER 20 I HEREBY CERTIFY that I proofread the transeript for 21 accuracy in spelling, hyphenation, punctuation and 22 format.

24 — _ Finda. Q. Ramen _ _ 25 WANDA J. RAVER For The Record, Inc.

(301) 870-8025 - www. ftrinc.net - (800) 921-5555 BRAIN-PAD, INC. 481 Complaint Exhibit B WiRlLdui de I /200% Aarushi MAG <<BRAING PAD? IMMVMATOR GANZ ATIOINS i PROTEO SOLUTIONS ¥, : ‘ % ; fist US SSUSINES) fH for POWER CLENCH & BREATHEDESIGN! ATRONS DISCOU! : 15% OFF: am | id Meee LUNGS STOMAG BP0O0075 VOLUME 154 Complaint Exhibit C BRAIN-PAD, INC. 483 Complaint Exhibit D Wrote Maal AVTURITY Me\é.

(Ceaain@env)) Jaw Joint Protectors”

PROTECTION 3 PERFORMANCE | Protects TMJ & Brain from Jaw Impacts * Reduces the risk of Concussion * Dual Arch protective designs * Offers Clench & Breathe technology * Protects Upper and Lower Braces SXS-NP[non-strap) SXS-W/Phwith-strap) Lower Tapered Channel Ends channel Remove need to: jaw stabilizer Opens trim | prow” “A Helmet tether included Intl. Combat Sport Organizations Mandate Dual Arch Mouth Guard Designs - Only ‘Jaw Joint Protectors’ Reduce the Risk of | Concussion & Internal Head Injuries, Brain-Pad’ Designs create a Jaw Joint / Brain ‘ Safety Space ’ ! Foreign Porat) seater Psa) Pasting sues) G10 397 0893 www.brainpads.com [email protected] ‘oie Bana Pad ine All Fagjais Planarendl BP00131 VOLUME 154 Complaint Exhibit E BRAIN-PAD, INC.

Complaint unprotected area for athletes. When used properly, there is a 40 percent reduction of impact energy to the base of the skull, these forces can cause a concussion of knock out.as boxers call it Athletes from the NFL te the MMA, and at every level from professional to local youth leagues are recognizing the significant health benefits of our Brain-Pad mouth guards to offer protection against these dangerous Injuries.” The House Judiciary Committee, chaired by Representative John Conyers, D-Michigan, will hear testimony on Monday to examine the NFL's response to concussion injuries and assass the protocols or lack thereof, in place for college -and-high' school football players. Scheduled’ |" witnesses include NFL neurologist Ira Casson, DeMaurice Smith, the executive director of the NFL, Players Association, David Klossner, the NCAA"s director of health and safety and Dr. Bennet Omalu, a neyropathologist and primary researcher into brain damage in football players.

Brain-Pad mouth quards are available at leading athletic retailers including Wal-Man® stores nationwide, and retail between $7 and $30 based on the model. ABOUT BRAIN-PAD, ING.

A privately held comporation, founded in 1995 specifically for the promotion, manufacture, and sale of customized Brain-Pad@ dual-arch mouth-quards designed to reduce the risk of concussion from lower jaw Impacts while increasing endurance and performance. Brain-Pad, Inc. has become a leader in technology development in this field. Its Brain-Pad@ products are available in retail and wholesale outlets as well as through distributors, contact sports leagues, professional organizations, school teams at intermediate, high-school, collage, and university level. Brain-Pad® products are well-accepted by professional sports athletes in boxing, mixed martial arts, football and many other contact sports, Brain-Pad@ products also include shock-absorbing wrist, arm and head-bands as well as: juniors’, women’s, men's, and professional athlete's dual-arch protective and high perfarmance mouth-quards. ‘| Additionally, Brain-Pad, Inc. recently developed, patented, and commercially released a premiurn ultra-vicleVozone oral appliance sanitizer, the Naturezone™, ayailabla to the retailers and distributors but exclusively distributed to the professional dental industry by Henry Schein, Inc., the largest global distributor of dental and medical products to dentists, dental laboratories and physicians, Brain-Pad, Inc.'s comorate headquarters are located in Conshohocken, Pennsylvania. For product or company details contact 610-397-0893, [email protected], or visit www. braingads.com Photos/Multimedia Gallery Available: httpy'Avww. business wire.com/cql- DIEING. od 72002634 / 157 SlEng2en Contacts Brain Pad Protective Solutions Bill Samuel Director of Sales [email protected] www. brainpads.com 1-888-424-9477 BP00255 VOLUME 154 Complaint Exhibit F BRAIN-PAD, INC. 487 Decision and Order DECISION AND ORDER The Federal Trade Commission (“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 complaint that the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge the respondents with violation of the Federal Trade Commission Act, 15 U.S.C § 45 et seq.; and The respondents, their attorney, and counsel for the Commission having thereafter executed an agreement containing a consent order (“consent agreement”), an admission by the respondents of all the jurisdictional facts set forth in the aforesaid draft complaint, a statement that the signing of said consent agreement is for settlement purposes only and does not constitute an admission by the respondents that the law has been violated as alleged in the complaint, or that the facts as alleged in such complaint, other than jurisdictional facts, are true, 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 has reason to believe that the respondents have violated the Federal Trade Commission Act, and that a complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such consent agreement on the public record for a period of thirty (30) days, and having duly considered the comments filed thereafter by interested persons pursuant to Section 2.34 of its Rules, now in further conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order: 1. Respondent Brain-Pad, Inc. (“BPI”) is a Pennsylvania corporation with its principal office or place of business at 322 Fayette Street, Conshohocken, Pennsylvania 19428.

2. Respondent Joseph Manzo is the President of BPI. Individually or in concert with others, he formulates, VOLUME 154 Decision and Order directs, controls, or participates in the policies, acts, or practices of BPI. His principal office or place of business is the same as that of BPI.

ORDER DEFINITIONS For purposes of this Order, the following definitions shall apply:

A. Unless otherwise specified, “respondent BPI” shall mean Brain-Pad, Inc., a corporation, its successors and assigns and their officers, and each of the above’s agents, representatives, and employees. B. “Respondent Manzo” shall mean Joseph Manzo and his agents, representatives, and employees. C. “Respondents” shall mean respondent BPI and respondent Manzo.

D. “Commerce” shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44. E. “Competent and reliable scientific evidence” shall mean tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results. F. “Covered Product” shall mean any (1) mouthguard or (2) equipment used in athletic activities that is intended, in whole or in part, to protect the brain from injury.

G. The term “including” in this Order shall mean “without limitation.”

H. The terms “and” and “or” in this Order shall be construed conjunctively or disjunctively as necessary, to make the applicable phrase or sentence inclusive rather than exclusive.

BRAIN-PAD, INC. 489 Decision and Order I.

IT IS ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, 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 represent, in any manner, expressly or by implication, including through the use of a trade name, product name, endorsement, depiction, or illustration, that such product will:

A. reduce the risk of concussions; or B. reduce the risk of concussions from lower jaw impacts, unless the representation is true, non-misleading, and, at the time of making such representation, respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

II.

IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered 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, or research, including, but not limited to, any misrepresentation that: A. scientific studies prove such product reduces the risk of concussions; or B. scientific studies prove such product reduces the risk of concussions from lower jaw impacts. VOLUME 154 Decision and Order III.

IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale or distribution of any Covered Product, in or affecting commerce, shall not represent in any manner, expressly or by implication, including through the use of a trade name, product name, endorsement, depiction, or illustration, the health benefits, health-related performance, or health-related efficacy of any such product, unless the representation is true, non-misleading, and, at the time of making such representation, respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.

IV.

IT IS FURTHER ORDERED that respondent BPI, and its successors and assigns, and respondent Manzo shall, for five (5) years after the last date of dissemination of any representation covered by this Order, maintain and upon reasonable notice 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 its 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.

BRAIN-PAD, INC. 491 Decision and Order V.

IT IS FURTHER ORDERED that respondent BPI, and its successors and assigns, and respondent Manzo shall deliver a copy of this Order to all current and future principals, officers, directors, and other employees 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 date of service of this Order, and to future personnel having responsibilities with respect to the subject matter of this Order within thirty (30) days after the person assumes such position or responsibilities. VI.

IT IS FURTHER ORDERED that respondent BPI, and its successors and assigns, shall notify the Commission at least thirty (30) days prior to any change in the corporation that may affect compliance obligations arising under this Order, including, but not limited to, 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 fewer 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. Unless otherwise directed by a representative of the Commission in writing, all notices required by this Part shall be emailed to [email protected] or sent by overnight courier to: Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. The subject line must begin: Brain-Pad, Inc., FTC File No. 122-3073.

VII.

IT IS FURTHER ORDERED that respondent Manzo, for ten (10) years after the date of issuance of this Order, shall notify VOLUME 154 Decision and Order 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. Unless otherwise directed by a representative of the Commission in writing, all notices required by this Part shall be emailed to [email protected] or sent by overnight courier to: Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. The subject line must begin: Brain-Pad, Inc., FTC File No. 122-3073.

VIII.

IT IS FURTHER ORDERED that respondent BPI, and its successors and assigns, and respondent Manzo, within sixty (60) days after the date of service of this Order, shall each file with the Commission a true and accurate report, in writing, setting forth in detail the manner and form of their own compliance with this Order. Within ten (10) days of receipt of written notice from a representative of the Commission, respondents shall submit additional true and accurate written reports. IX.

This Order will terminate twenty (20) years from the date of its issuance, 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 C. This Order if such complaint is filed after the order has terminated pursuant to this Part.

BRAIN-PAD, INC. 493 Analysis to Aid Public Comment Provided, further, that if such complaint is dismissed or a federal court rules that 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 CONSENT ORDER TO AID PUBLIC COMMENT The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Brain-Pad, Inc. and Joseph Manzo, an officer and director of the corporation (“respondents”). The proposed consent order (“proposed 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 and take appropriate action or make final the agreement’s proposed order.

This matter involves respondents’ advertising and promotion of mouthguards. According to the FTC complaint, respondents did not have a reasonable basis to represent in advertising and on packaging for their mouthguards that they reduced the risk of concussions. The FTC further alleges that the respondents made the false and misleading claim that they possessed scientific studies that proved their concussion-reduction risk claims because, in fact, they did not have such evidence. VOLUME 154 Analysis to Aid Public Comment The proposed consent order contains provisions designed to prevent respondents from engaging in similar acts and practices in the future. Part I of the proposed order prohibits the proposed respondents from misrepresenting that any product will reduce the risk of concussions or reduce the risk of concussions from lower jaw impacts.

Part II of the proposed order prohibits proposed respondents from misrepresenting, with respect to any Covered Product, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, including, but not limited to, any misrepresentation that scientific studies prove that such product reduces the risk of concussions or reduces the risk of concussions from lower jaw impacts. The proposed order defines “Covered Product” as any (1) mouthguard or (2) equipment used in athletic activities that is intended to protect the brain from injury.

Part III of the proposed order prohibits proposed respondents, in connection with the marketing of any Covered Product, from misrepresenting the health benefits, health-related performance, or health-related efficacy of such product. Parts IV through VIII of the proposed order require respondents: to keep copies of any documents relating to any representation covered by the order; to provide copies of the order to certain of their personnel; to notify the Commission of changes in corporate structure that might affect compliance obligations under the order; to notify the Commission of changes in corporate business or employment as to proposed respondent Joseph Manzo individually; and to file compliance reports with the Commission. Part IX provides that the order will terminate after twenty (20) years, with certain exceptions.

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.

ALAN B. MILLER 495 Complaint