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OUR FIRM ASSISTS COMPANIES TO UNDERSTAND, MANAGE AND COMPLY WITH FEDERAL REGULATORY REQUIREMENTS—MORE IMPORTANT TODAY THAN EVER BEFORE.






























































































VIGOROUS FTC ENFORCEMENT

Today, new leadership is in place at FTC and FDA—

  • It is enforcement oriented and and more cases are being initiated. Both agencies are taking a much harder look at business, large and small. FTC, especially, is taking action and employing its full panoply of remedies. 

  • In many cases, FTC is going directly to federal district court, without prior notice to companies, seeking prohibition of advertising claims, appointment of a Receiver to run the business and asset freezes.

  • FTC is working closely with FDA, state Attorneys General and local law enforcement authorities, as well as with foreign governments, to halt illegal interstate and cross border business practices.  

  • FTC’s closer coordination with FDA is apparent. In recent cases, FTC required defendants who are under FTC order to obtain pre-approval from FDA before making disease claims for any supplement or drug in the future. 

FTC is now exercising its antitrust jurisdiction more frequently

  

  • FTC shares jurisdiction with the Justice Department to enforce antitrust statutes. FTC has additional enforcement powers under Section 5 of the FTC Act to broadly prohibit “unfair methods of competition and deceptive acts and practices in commerce.” 

  • Since Jan. 2009, FTC has filed six antitrust lawsuits, entered into more than two dozen consent decrees, and continues to litigate matters initiated years ago. 

  • The most publicized recent antitrust case is against Intel Corp. FTC charged that Intel illegally stifled competition in the computer chip market. Under its Section 5 authority, FTC alleged that Intel used anticompetitive tactics to cut off rivals’ access to the marketplace and deprive consumers of choice and innovation in the microchips that comprise computers’ central processing unit, the “brains” of a computer.  

  • Intel settled before going to trial. Intel is now prohibited from conditioning benefits to computer makers in exchange for their promise to buy chips exclusively from Intel, or to refuse to buy chips from others in the future.  Intel is also prohibited from retaliating against computer makers who do business with non-Intel suppliers by withholding benefits from them. FTC also required several other major modifications of Intel’s business practices.  (FTC File No. 061 0247)


 INCREASED FDA ENFORCEMENT 

  • FDA announced in August 2009 that the enforcement actions it takes in the future will be “swift, aggressive and have a positive impact on consumer protection and public health.”  

  • FDA says it will not issue multiple Warning Letters to non-compliant firms before taking enforcement actions. Further, to address significant health concerns or egregious violations, FDA will consider taking immediate action even before issuing a Warning Letter. 

  • After issuance of a Warning Letter or recall, FDA is now committed to following up promptly and will take enforcement action if necessary to achieve compliance.  

  • A firm’s recidivist compliance history will also bear heavily in FDA’s decision on how to proceed.

OUR FIRM ASSISTS COMPANIES COMPLY WITH FTC and FDA RULES and REGULATIONS 


  • Letters of Inquiry, Warning Letters and Subpoenas are issued by FTC and FDA.  

  • Recipients must respond quickly, accurately and to the fullest extent. That means providing extensive documentation and possible testimony under oath. Investigations interfere with the normal course of business. They are usually time-consuming, expensive, and can be anxiety producing.  

  • Investigations involve business owners and may involve business partners, corporate officers, employees, suppliers, distributors, vendors, ad agencies, and consumers. 

  • In some cases, companies may not be given an initial opportunity to respond to FTC.  FTC may proceed directly to federal district court, without prior notice, to seek to enjoin temporarily, advertising claims and business practices, to freeze assets, and have a Receiver appointed to run the business.  

  • In court or through settlement, FTC will press for permanent relief and may seek a determination of how much money has to be returned to consumers. A company’s response may only be a public one – in court.

  • Failure to comply with all laws and regulations, whether companies are aware of them or not, might result in consequences described above.  

  • Furthermore, individuals may also be held liable if they actively participated in allegedly illegal business practices or were in a position to prevent those practices from occurring. 


    FTC Consumer Protection—Understanding the Law and Corporate and Individual Liability

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