Confidentiality Agreement

When parties enter into business arrangements, they generally provide information to each other which may be of a confidential nature. It is therefore, necessary, for them to enter into a Confidentiality Agreement whereby any unauthorized disclosure by the parties is prohibited. A Confidentiality Agreement between parties XYZ and ABC should typically contain the following clauses:

Definition of what constitutes “confidential information”

Indicate that the kinds of information have been mentioned on an “includes but not limited to” basis. You may include commercial, technical, financial information; trade secrets; software; designs; trademarks; copyright; studies; reports; marketing plans; business strategies; customer lists; employee details; etc.

If any particular kind of information is excluded from the scope of “confidential information.” Information generally not considered confidential includes:

Information that is in the public domain;

Information that is required to be disclosed under any law, rule, regulation or statutory compliance;

Information which was already in possession of the party to whom it is disclosed;

Information that is developed independently by the party to whom it was disclosed.

The duration of the Agreement and till when it will survive : In some cases the Confidentiality Agreement survives for a certain time even when the business arrangement is over, say about a year.

Termination clause stating the grounds for termination:

Breach of the Agreement is a ground for termination.

There may be a clause included saying that the Agreement can be terminated by mutual consent of the parties in writing.

Non-disclosure clause:

Confidential Information should be kept in safe custody by the party to whom disclosure has been made.

Disclosure cannot be made to any third party.

No publishing of the information in any way.

Employees of the party to which information has been disclosed should use best efforts to make sure that no unauthorized disclosures are made.

Information will be used solely for the purpose of the business arrangement between the parties.

No reproduction/copies of the information can be made without the consent of the party giving the information.

Documents, etc. to be returned on termination of agreement or on request

On termination of the Agreement, all documents and other material provided must be returned by the party to whom the disclosure has been made and a notarized certificate should be provided stating that all the documents, materials, etc. have been returned / destroyed.

No rights created under the Agreement:

The Agreement does not in any way create a license in favour of the party to whom the information is disclosed and all intellectual property rights shall remain vested in the party providing the information.

No representation or warranty regarding information:

The party providing the information does not make any representation or warranty regarding the accuracy or completeness of the information.

Consequences of Breach of Agreement:

A number of remedies maybe adopted in case of breach of agreement including cease and desist notice to stop unathorised use of the information, damages, etc.

Right of inspection:

Party providing the information should be given the right to inspect the premises and records of the other party (after giving them prior notice) during business hours on business days to make sure that the information has not been disclosed and has been kept in safe custody. 

No agency or partnership deemed to be created:

No relationship of agency, partnership, etc. is deemed to be created between the parties by virtue of the Agreement.

Standard clauses including Amendments, Severability, Jurisdiction, etc.

Limited Liability Partnership Agreement in India

Every LLP shall file information with regard to the limited liability partnership agreement in Form 3 with the Registrar within thirty days of the date of incorporation along with the fee as provided in Annexure ‘A’ of the Rules.

Provided that any change made in the limited liability partnership agreement shall be filed in Form 3 within thirty days of such change along with the fee as provided in Annexure ‘A’ of the Rules.

Incorporation of a Limited Liability Partnership in India

                                                          

LLP is governed under the Limited Liability Partnership Act, 2008 and the Limited Liability Partnership Rules, 2009.

For a LLP to be incorporated, 2 or more persons associated for carrying on lawful business with a view to profit shall subscribe their names to an incorporation document.

The incorporation document shall be filed in Form 2 with the Registrar having jurisdiction over the State in which the registered office of the limited liability partnership is to be situated alongwith the fee as provided in Annexure ‘A’ of the Rules.

The incorporation document shall:

State the name of the LLP;

State the proposed business of the LLP;

State the address of the registered office of the LLP;

State the name and address of each of the persons who are to be designated partners of the LLP on incorporation;

Contain such other information as may be prescribed.

In case of foreign nationals residing outside India in countries signatory to the Hague Apostile Convention, 1961 and seeking to register a LLP in India, their signatures and address on the incorporation documents and proof of identity, where required, shall be notarized before the notary of the country of their origin and be duly apostillised in accordance with the said Hague Convention.

In the office of Registrar there shall be maintained a Register of LLPs in which the names of LLPs shall be entered in the order in which they are registered.

Every LLP so registered shall be assigned a LLP identification number (LLPIN) in one consecutive series.

A LLP shall give an address for service of documents within the jurisdiction of the Registrar where its registered office is situate. Such address shall include the postal code and e-mail address.

The LLP, may, in addition to the registered office address, declare any other address as its address for service of documents in the manner as laid down in the limited liability partnership agreement. Where the limited liability partnership agreement does not provide for such manner, consent of all partners shall be required for declaring any other address as the address for service of documents.  

The intimation of other address for service of documents to LLP shall be given to the Registrar in Form 12, within thirty days of complying with the requirements above along with the fee as mentioned in Annexure ‘A’ of the Rules.

The LLP may change its registered office from one place to another by following the procedure as laid down in the limited liability partnership agreement. Where the limited liability partnership agreement does not provide for such procedure, consent of all partners shall be required for changing the place of registered office of the LLP to another place.

A LLP may change its registered office and file the notice of such change to the Registrar in Form 15, within 30 days of complying with the requirements above, along with the fees as mentioned in Annexure ‘A’ of the Rules.

Where the change in place of registered office is from one state to another state, the LLP shall publish a general notice, not less than 21 days before filing any notice with Registrar, in a daily newspaper published in English and in the principal language of the district in which the registered office of the LLP is situated and circulating in that district giving notice of change of registered office.

Where the change in registered office is from one place to another, where the Registrar within whose jurisdiction the office falls will change, the LLP will file the notice in Form 15 with the Registrar from where the LLP proposes to shift its office, with a copy to the Registrar under whose jurisdiction the office is proposed to be shifted. 

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Name Approval for a Limited Liability Partnership in India

LLP is governed under the Limited Liability Partnership Act, 2008 and the Limited Liability Partnership Rules, 2009.

The name of the limited liability partnership shall not be one prohibited under the Emblems and Names (Prevention of Improper Use) Act, 1950.

A name shall not generally be reserved, if –

·         it includes any word or words which are offensive to any section of the people;

·         the proposed name is the exact Hindi or English translation of the name of an existing LLP in English or Hindi, as the case may be;

·         the proposed name has a close phonetic resemblance to the name of a LLP in existence, for example, J.K. LLP., Jay Kay LLP;

·         it includes the word Co-operative, Sahakari or the equivalent of word 'co-operative' in the regional languages of the country;

·         it connotes the participation or patronage of the Central or State Government, unless circumstances justify to, e.g., a name may be deemed undesirable in certain context if it includes any of the words such as National, Union, Central, Federal, Republic, President, Rashtrapati, etc;

·         the proposed name contains the words 'British India';

·         the proposed name implies association or connection with any Embassy or Consulate or of a foreign government which suggests connection with local authorities such as Municipal, Panchayat, Zila Parishad or any other body connected with the Union or State Government;

·         the proposed name is vague like D.I.M.O. Limited liability partnership or I.V.N.R. Limited liability partnership or S.S.R.P Limited liability partnership;

·         it is different from the name or names of the existing LLP only to the extent of having the name of a place within brackets before the word ‘limited liability partnership’, for example, Indian Press (Delhi) LLP should not be allowed in view of the existence of the LLP named Indian Press LLP;

·         it includes name of registered Trade mark, unless the consent of the owner of the trade mark has been produced;

·         the proposed name is identical with or too nearly resembles the name of a firm or LLP or company incorporated outside India and reserved by such firm, LLP or company with the registrar in accordance with these rules;

·         it is identical with or too nearly resembles the name of the LLP or a company in liquidation or it is identical with or too nearly resembles names of the LLP or a company which is struck off, up to the period of 5 years;

·         it includes words like 'Bank', 'Insurance' and 'Banking', ‘Venture capital’ or ‘mutual fund’ or such similar names without the approval of the regulatory authority;

·         it is intended or likely to produce a misleading impression regarding the scope or scale of its activities which would be beyond the resources at its disposal;

·         the proposed name includes words like French, British, German etc., unless the partners satisfy that there is some form of collaboration and connection with the foreigners of that particular country or place, the name of which is incorporated in the name;

·         the proposed name of the LLP includes the words company secretary, chartered accountant, advocates or such similar words as indicative of a profession, as part of the proposed name, the same shall be allowed only after obtaining approval from the Council governing such profession or such authority as may be nominated by the Central Government, in this behalf.

A foreign LLP or a foreign company may on payment of fee as mentioned in Annexure ‘A’ of the Rules, apply in Form 25 to the Registrar for reserving its existing name by which it is registered in the country of its regulation or incorporation: Provided that such reservation shall be valid for three years but may be renewed on a fresh application along with payment of fee as provided in Annexure ‘A’ of the Rules.

An application for reservation of name with which the proposed LLP is to be registered or for change of name, as the case may be, shall be made to the Registrar having jurisdiction where the registered office of the LLP is to be situate. Every such application shall be in Form 1 and be accompanied by fee as mentioned in Annexure ‘A’ and the Registrar shall inform to the applicant for reservation or non reservation of the changed name or the name with which the proposed LLP is to be registered ordinarily within seven days of the receipt of application. 

Limited Liability Partnership in India - Partners

LLP is governed under the Limited Liability Partnership Act, 2008 and the Limited Liability Partnership Rules, 2009.

A LLP is a body corporate having perpetual succession. Any change in the partners of a LLP shall not affect the existence, rights or liabilities of a LLP.

Any individual or body corporate may be a partner in a LLP.

“body corporate” means a company as defined under section 3 of the Companies Act, 1956 and includes:

a)      a LLP registered under the Limited Liability Partnership Act, 2008;

b)      a LLP incorporated outside India;

c)       a company incorporated outside India;

but does not include:

a)      a corporation sole;

b)      a co-operative society registered under any law for the time being in force;

c)       any other body corporate (not being a company as defined under section 3 of the Companies Act, 1956 or a LLP as defined under the Limited Liability Partnership Act, 2008), which the Central Government may, by notification in the Official Gazette, specify in this behalf. 

An individual shall not become a partner if:

a)      he has been found of unsound mind by a court of competent jurisdiction and the finding is in force;

b)      he is an undischarged insolvent;

c)       he has applied to be adjudicated as an insolvent and his application is pending.

In order to set up a LLP there must be a minimum of 2 designated partners, at least one of whom should be a resident Indian.

The term resident in India means a person who has stayed in India for a period of not less than 182 days during the immediately preceding one year.

The two designated partners must have a designated partner identification number (DPIN) and a digital signature.

Every individual or nominee of a body corporate, who is intending to be appointed as designated partner of a limited liability partnership shall make an application electronically in Form 7 to the Central Government for obtaining Designated Partner Identification Number (DPIN). The DPIN can be obtained by making an online application at www.llp.gov.in upon which the system will generate a provisional DPIN.

A provisional DPIN generated online by the applicant will remain valid for a period of sixty days from the date on which it was generated.

The applicant shall, after the allotment of provisional DPIN, submit an application to the Central Government along with the fee as mentioned in Annexure ‘A’ of the Rules for the allotment of regular DPIN within sixty days from the date on which provisional DPIN was generated on-line, failing which the provisional DPIN will lapse.

For making an application for allotment of DPIN, the applicant shall take a print out of Form 7, affix his photograph in the space provided in that Form, enclose true copies of the proof of identity and proof of residence and physically sign the form at the place specified therein. The photograph and the proof of identity and residence shall be certified by any one of the following authorities: Gazetted officer of the Central or State Government; Notary Public; Chartered Accountant, Cost Accountant or Company Secretary. 

Central Government shall process the applications within a period of one month.

The DPIN so allotted is valid for the life time of such applicant and shall not be allotted to any other person in any case.

Every designated partner shall intimate his consent to become a designated partner to the limited liability partnership and DPIN in Form 9 and the LLP shall intimate such DPIN to Registrar in Form 4.

Every designated partner, who has been allotted a DPIN under the Rules, shall, in the event of any change in his particulars as stated in Form 7, intimate such change(s) to the Central Government within a period of 30 days of such change(s) in Form 10.

The concerned designated partner shall also intimate such changes to the LLP or LLP(s) on which he is a designated partner within 30 days of such changes.

Every partner shall intimate change in his name or address to the LLP in Form 6.

Where a person becomes or ceases to be a partner or where there is any change in the name or address of a partner, the LLP shall file with the Registrar, a notice in Form 4.

Right to Education in India

Many Indian states have already passed legislations to make free and compulsory education available to children. However, enforcement has not taken place since the legislations generally leave implementation to the local authorities as optional. With the inclusion of education as a subject in the Concurrent List of the Constitution since 1976, the burden of making quality education available to all children is also required to be shared by the Centre.

Right of Children to Free and Compulsory Education Act, 2009

Background

India is a signatory to the Universal Declaration of Human Rights, 1948, which recognises the right of children to free and compulsory education.[1] The Convention on the Rights of Child, 1986, also stresses upon the importance of education for a brighter future of children.[2] Right to free and compulsory education has been a part of the Directive Principles of State Policy enshrined in the Indian Constitution since the beginning in the form of Article 45.  The Honourable Supreme Court granted free and compulsory education (between the age of six and fourteen years) the status of being a fundamental right in the cases of Mohini Jain versus State of Karnataka[3] and Unnikrishnan versus State of Andhra Pradesh.[4] Beyond that stage, the State obligation to provide education is subject to its “limits of the economic capacity and development.” Education was recognized as being fundamental to live a good and dignified life. In consonance with its international commitments and national objectives the Parliament enacted the 86^th Constitutional Amendment Act, 2002, adding Article 21-A to the Indian Constitution which provides that every child between the age of 6 and 14 years has the right to free and compulsory education. The Right of Children to Free and Compulsory Education Act, 2009 (hereinafter referred to as the Act) seeks to give effect to this amendment.  It received Presidential assent, was notified as a law on 3^rd September, 2009 and was enforced on April 1, 2010. The Act applies to schools fully or partially owned by the Central or State Governments or schools receiving any kind of grant from the Central or State Governments. The expenses for carrying out the provisions of the Act have to be borne by both the Central and State Governments. The earlier draft of the Bill as made in 2005 could not make its place in the statute book because of severe disagreements over several of its provisions. Most developed countries have legislated free and compulsory education for all. UNESCO has calculated that in the next 30 years more people will receive education than in the whole of history thus far.

 Key Provisions

The content of the Act is well meaning and flexible to say the least. 25% reservation is provided for in the private schools at entry level (Class I) for disadvantaged children.[5] They will be reimbursed by the Government.[6]

The Act also makes provision for no donation or capitation fee and no interview of the parent or child for admission.[7] Capitation fees have become a nightmare for parents in recent years. It is becoming increasingly difficult to get one’s child admitted in a so-called good school without paying lacs of rupees as donation. When parents will hardly be able to afford good schooling for their children, how will they provide them with higher education? Simultaneously, competition has become so stiff that any number of degrees may not be enough for a student to get a decent job.

Children shall not be denied admission in a school due to lack of age proof.[8] This is highly relevant in villages and other rural areas where many parents may not have the required and documented age proof ready.

The Act is liberal in approach while allowing children to get admission in schools even in the middle of the academic year.[9]

The education system in India is considered pressurising and stressful as compared to other countries. It is not an uncommon sight to see children carrying bags loaded with books heavier than themselves. An extremely encouraging step in the Act provides that no child shall be held back or expelled up to class VIII.[10]

Another positive feature of the Act is that children are protected from physical and mental harassment.[11] Though it seems that physical punishment is extinct in the modern times, news reports prove otherwise. Stray cases of physical harassment are reported every now and then even in well-reputed schools. If this is the case in well-developed and aware metropolitan cities, one shudders to think what it must be like in villages and smaller towns where the press and media still haven’t reached.

Schools will be given recognition under the Act only when they meet the norms prescribed in the Schedule. The schools are obligated to meet the norms specified in the Act within 3 years.[12]

The Act provides that teachers must obtain the necessary academic qualifications within 5 years or else they will lose their jobs.[13]

The Act imposes responsibility on the appropriate Government and local authority to ensure within six months from the date of commencement of the Act that the required pupil-teacher ratio as stipulated in the Schedule is maintained.[14]

Training will also be provided to the teachers and they will be forbidden from squandering away their time in non-educational purposes other than decennial population census, disaster relief duties or duties relating to elections.[15]

Teachers are directed to not be engaged in private tuitions and private teaching activity.[16] This is another welcome provision since many teachers use their position of power over students to force them to take private tuitions.

Every child completing elementary education shall be awarded a certificate.[17]

The Act, if implemented properly will completely revolutionize education in India.

The National Commission for Protection of Child Rights along with the State Commissions is the monitoring agency under the Act.[18] The Act also provides for the establishment of School Management Committees comprising of parents, guardians, teachers and representatives of the local authority to oversee the implementation of the Act.[19] It shall be seen in the course of time whether these committees will prove to be effective and corruption free.

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[1] Article 26

[2] Article 28

[3] AIR 1992 SC 2100

[4] AIR 1993 SC 2178

[5] Section 12(1)(c)

[6] Section 12(2)

[7] Section 13 (1)

[8] Section 14(2)

[9] Section 15

[10] Section 16

[11] Section 17(1)

[12] Section 19(2)

[13] Section 23(2)

[14] Section 25(1)

[15] Section 27

[16] Section 28

[17] Section 30(2)

[18] Section 31(1)

[19] Section 21(1)

Family Smoking Prevention and Tobacco Control Act, 2009 – An Analysis of the US Law

Introduction.- The Family Smoking Prevention and Tobacco Control Act, 2009 amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA), including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. The Act was signed into law on June 22, 2009 by President Barack Obama.

Enforcement of the Act

Any violation of this Act pertaining to advertising is deemed to be an unfair or deceptive act or practice under section 5(a) of the Federal Trade Commission (FTC) Act. The Chairman of FTC is required to coordinate with the Secretary concerning enforcement of the FTC Act for the advertisement of cigarettes or smokeless tobacco. The Secretary is also required to consult with the Chairman in revising the label statements and requirements for tobacco products under the FTC Act.   (s.914)

Authority- The Act grants the federal government authority to regulate tobacco products Directs the Secretary to establish within FDA: (1) the Center for Tobacco Products to implement this Act and to be established not later than 90 days after its commencement; and (2) an identifiable office to provide technical and other non financial assistance to assist small tobacco product manufacturers in complying with this Act (s.901).

Tobacco Products Scientific Advisory Committee.- Not later than 6 months after the date of enactment, the Secretary shall establish a 12-member advisory committee known as the Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to the Secretary, including on the effects of altering nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved. (s.917)

Application of the Act.-The Act shall not:

a)     Prohibit federal agencies, states, political subdivisions, or Indian tribes from enacting additional or more stringent measures, except requirements relating to tobacco product standards, pre market review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products;

b)    Prohibit state, tribal, or local taxation of tobacco products; and

c)     Modify or affect the liability of any person under the product liability laws of any state.(s.916)

Provisions.

Definition of Tobacco product.- A tobacco product is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). A tobacco product is prohibited from being marketed in combination with any other article or product regulated under Federal Food, Drug, and Cosmetic Act (FFDCA).

Labeling and Advertising.

Label.- Section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) is amended. Cigarette packages must contain one of the following labels:

‘‘WARNING: Cigarettes are addictive.”
‘‘WARNING: Tobacco smoke can harm your children.”

‘‘WARNING: Cigarettes cause fatal lung disease.”

‘‘WARNING: Cigarettes cause cancer.”

‘‘WARNING: Cigarettes cause strokes and heart disease.”

‘‘WARNING: Smoking during pregnancy can harm your baby.”

‘‘WARNING: Smoking can kill you.”

‘‘WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.”

‘‘WARNING: Quitting smoking now greatly reduces serious risks to your health.” -s.201(a)(1)

Graphic Label Statements.- Not later than 24 months after the date of enactment, the Secretary shall issue regulations that require colour graphics depicting negative health consequences of smoking. s.201(d)

Placement of Label.- Each label shall be located in the upper portion of the front and rear panels of the package, directly on the package underneath the cellophane or other clear wrapping. The word ‘WARNING’ shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label statement would occupy more than 70 percent of such area, in which case the text may be in a smaller conspicuous and legible type size, provided that at least 60 percent of such area is occupied by required text. The text shall be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with all other printed material on the package, in an alternating fashion. s.201(a)(2)

Advertising.- Advertisement is prohibited if it does not bear the label specified above. The standards for advertising are as follows.-

a)    For press and poster advertisements, each such statement and (where applicable)

b)   any required statement relating to tar, nicotine, or other constituent (including a smoke constituent) yield shall comprise at least 20 percent of the area of the advertisement and shall appear in a conspicuous and prominent format and location at the top of each advertisement within the trim area. The Secretary may revise the required type sizes in such area in such manner as he deems appropriate.

c)    The word ‘WARNING’ shall appear in capital letters, and each label statement shall appear in conspicuous and legible type.

d)   The text of the label statement shall be black if the background is white and white if the background is black. The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital ‘W’ of the word ‘WARNING’ in the label statements.

e)    The text of such label statements shall be in a typeface pro rata to the following requirements:

1. 45-point type for a whole-page broadsheet newspaper advertisement;
2. 39-point type for a half-page broadsheet newspaper advertisement;
3. 39-point type for a whole-page tabloid newspaper advertisement;
4. 27-point type for a half-page tabloid newspaper advertisement;
5. 31.5-point type for a double page spread magazine or whole-page magazine advertisement;
6. 22.5-point type for a 28 centimeter by 3 column advertisement; and
7. 15-point type for a 20 centimeter by 2 column advertisement.

f)     The label statements shall be in English, except that:

                         i.         In the case of an advertisement that appears in a publication that is not in English, the statements shall appear in the predominant language of the publication; and

                       ii.         In the case of any other advertisement that is not in English, the statements shall appear in the same language as that principally used in the advertisement. s.201(b)

Authority to Revise Warning Label Statements.- The Secretary has the authority to alter label requirements to promote greater public understanding of the risks associated with the use of tobacco products. States or localities are allowed to impose specific bans or restrictions on the time, place, and manner, but not the content, of the advertising or promotion of any cigarettes. (s.202, 203)

Smokeless Tobacco Products.- The Comprehensive Smokeless Tobacco Health Education Act of 1986 is amended to apply the same restrictions on labeling and advertising to smokeless tobacco products. (s.204)

Disclosure to the Public.- The Secretary is to determine whether manufacturers should be required to include on the label and advertisements the tar and nicotine yields of the product. The Secretary is to determine disclosure of the level of constituents in a tobacco product if such disclosures would benefit the public health or increase consumer awareness of the health consequences of the use of tobacco products (s.206)

Adulterated tobacco product.- A tobacco product is deemed to be adulterated if

a)     It contains any filthy, putrid, or decomposed substance or is contaminated by any added poisonous or deleterious substance that may render the product injurious to health;

b)    It has been prepared, packed, or held under unsanitary conditions;

c)     Its package is composed of any poisonous or deleterious substance;

d)    The manufacturer or importer of the product fails to pay the assessed user fee;

e)     It fails to meet specified tobacco product standards;

f)     It does not have required premarket review;

g)     It fails to meet applicable requirements or conditions on manufacturing, packing, or storage; or

h)    It fails to conform to requirements for modified risk tobacco products (s.902)

Misbranded tobacco product.- A tobacco product is deemed to be misbranded if:

a)     Its labeling, packaging, or advertising contains any false or misleading information;

b)    Its label or advertising fails to contain all required information displayed prominently and conspicuously, including its established name, manufacturer, and contents and adequate directions and warnings;

c)     It was manufactured, prepared, or processed in an establishment not registered with the Secretary; or

d)    There is any failure to submit the required information or notices to the Secretary s.903(a)

Prior Approval of Label Statements.- The Secretary is allowed to require prior approval of all label statements on tobacco products to ensure that such statements: (1) do not violate misbranding provisions; and (2) comply with other provisions of this Act s.903(b)

Submission of information to the Secretary.- Requires tobacco product manufacturers or importers to submit to the Secretary:

a)     A listing of all ingredients, including ingredients added by the manufacturer to the tobacco, paper, or filter, by brand and quantity not later than 6 months after the enactment of the Act; 

b)    A description of the content, delivery, and form of nicotine in each tobacco product;

c)     A listing of all constituents, including smoke constituents, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, beginning 3 years after the date of enactment of the Act; and

d)    All documents developed that relate to the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents, ingredients, components, and additives, beginning 6 months after the date of enactment.

Additional Information.- The Secretary is allowed to request additional information from a tobacco product manufacturer or importer relating to: (1) research activities or findings on the effects of tobacco products and their constituents and on whether the health risk can be reduced if the manufacturer employs known or available technology; and (2) marketing research or practices used by manufacturers or distributors.-s.904(a)

Time for Submission.-

a)     The above required information shall be provided at least 90 days prior to the delivery for introduction into commerce, a product that is not already in the market on the date of enactment of the Act;

b)    If a tobacco product manufacturer adds new additive or increases an existing one, he shall atleast 90 days prior to such change inform the Secretary in writing;

c)     If a tobacco product manufacturer eliminates or decreases an existing additive or adds or increases an additive which the Secretary designates as not human or animal carcinogen or otherwise harmful to health, he shall within 60 days advise the Secretary in writing.- s.904(c)

Data List.- The Secretary is required to publicly display not later than 3 years after the date of enactment of the Act and thereafter annually, publish a list (that is understandable and not misleading to a lay person) of harmful or potentially harmful constituents in each tobacco product by brand and quantity.s.904(d)

Registration.- Owners and operators of both domestic and foreign establishments need to register with the Secretary and submit a list of all tobacco products manufactured in prescribed form and manner-

a)     Owners and operators of establishments in the United States engaged in the manufacture, preparation, compounding, or processing of a tobacco product are required to register annually with the Secretary on or before December 31 of each year.

b)    Owners and operators of new or additional establishments shall register immediately.

c)     The Secretary is allowed to prescribe a uniform system for the identification of tobacco products, which registrants must use. The Secretary is also required to make such registration information available to the public and to inspect registered establishments every two years.

d)    Requires foreign establishments to register and ensure that adequate and effective means are available to determine whether their tobacco products conform with FFDCA requirements.

Every person so registered shall submit a report to the Secretary once during the month of June and once during the month of December-

a)     A list of the tobacco products included after the previous list has been filed.

b)    If since the date of the last report made, manufacture of any tobacco product has been discontinued.

c)     If since the date of report of discontinuance, manufacture has been resumed (s.905)

Confidentiality of Information.-Prohibits the disclosure of privileged or confidential trade secrets and commercial financial information that is obtained by the Secretary s.906(c)

Restrictions.- The Secretary is allowed to restrict:

a)     The sale or distribution of tobacco products if appropriate for the protection of the public health; and 

b)    The advertising and promotion of tobacco products consistent with, and to the full extent permitted by, the First Amendment.

The following restrictions cannot be made: 

a)     Limit the sale or distribution of a tobacco product to written or oral authorization by a practitioner licensed to prescribe medicine;

b)    Prohibit the sale of a tobacco product in face-to-face transactions by a specific category of retail outlets; or

c)     Establish a minimum age of sale of tobacco products to any person older than 18 years of age.- s.906(d)

Regulations.- The Secretary is required to promulgate regulations to prevent the sale and distribution of tobacco products to minors through means other than a direct, face-to-face exchange between a retailer and a consumer within 18 months of the date of enactment. -s.906(d)(3)

Good Manufacturing Practices.-The Secretary is required to prescribe regulations to protect the public health and assure that tobacco products are in compliance with this Act by requiring good manufacturing practices or hazard analysis and critical control point methodology.- s.906(e)

The Secretary is required to:

a)     Provide a reasonable period for manufacturers to conform to good manufacturing practices; and

b)    Not require any small tobacco product manufacturer to comply with such regulations for at least four years. s.906(e)(1)(B)

The Secretary is allowed to grant exemptions and variances from such regulations under certain circumstances.

Tobacco Product Standards.-

a)    Beginning 3 months after the date of the enactment, the Act prohibits a cigarette or any of its components from containing as a constituent or additive any artificial or natural flavor (other than tobacco or menthol) or any herb or spice (including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee) that is a characterizing flavor of the tobacco product or tobacco smoke.-s.907(a)(1)(A)

b)   Beginning 2 years after the date of enactment a tobacco product manufacturer is prohibited from using tobacco, including foreign grown tobacco, that contains a pesticide chemical residue at a level greater than any tolerance applicable to domestically grown tobacco.-s.907(a)(1)(B)

a.     The Secretary is allowed to adopt additional tobacco product standards as appropriate to protect the public health, which may include standards for:

c)    Reducing nicotine yields;

d)   Reducing or eliminating other constituents or harmful components; and  

e)    Product testing.- s.907(a)(4)

The Secretary is allowed to amend or revoke a tobacco product standard.- s.907(a)(5)

Limitation on powers.- The Secretary is prohibited from:

a)     Banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

b)    Requiring the reduction of nicotine yields of a tobacco product to zero.-s.907(b)(3)

Notification.-The Secretary is to notify the public if a tobacco product poses an unreasonable risk of substantial harm to the public health. The Secretary is further required to order a cease in distribution and a recall of a tobacco product if there is a reasonable probability that it contains a defect not ordinarily contained in tobacco products that would cause serious, adverse health consequences or death. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order - s.908

Records and Reports.- Manufacturers and importers are required to comply with record keeping and reporting requirements established by the Secretary, such as informing the Secretary of any information that reasonably suggests that a marketed tobacco product may have caused or contributed to a serious unexpected adverse experience. The Secretary is also to require prompt notification by manufacturers and importers of any corrective action taken or any removal from the market of a tobacco product to reduce a health risk posed by the product or to remedy a violation of this Act that may present such a risk.- s.909

Pre market Review.

Pre market approval is required of all new tobacco products (products not substantially equivalent to an existing tobacco product) commercially marketed after February 15, 2007. "Substantially equivalent" is defined as having the same characteristics or having different characteristics but not raising different questions of public health.

Application for pre market approval.- An application process for pre market approval of a new tobacco product is set forth. Health information must be included. The Secretary may refer to the Tobacco Products Scientific advisory Committee for recommendations.  

Order.- Not later than 180 days on receipt of the application, the Secretary is authorized to: (1) allow, prohibit, or restrict distribution of such a tobacco product; and (2) temporarily suspend an application if the probability that continued distribution would cause serious, adverse health consequences or death is greater than that for tobacco products on the market.-s.910.

Modified Risk Tobacco Products

The sale of any modified risk tobacco product is prohibited unless an order is issued by the Secretary.

Definition.-A "modified risk tobacco product" is defined as any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related diseases associated with commercially marketed tobacco products, specifically products where:

a)     The labeling or advertising represents that the product presents a lower risk of tobacco-related disease or is less harmful than other tobacco products, contains a reduced level of or presents a reduced exposure to a substance, or is free of a substance;

b)    The labeling or advertising uses descriptors such as "light," "mild," or "low"; or

c)     The product manufacturer has taken action reasonably expected to result in consumers believing that the product or its smoke presents a lower risk of disease, is less harmful, presents a reduced exposure, or is free of a substance.- s.911(b)(1)

Application.- An application maybe filed with the Secretary for a modified risk tobacco product.- s.911(b). Not later than 60 days after receiving the application, the Secretary may refer it to the Tobacco Products Scientific Advisory Committee for its recommendations.- s.911(f)

Order.- The Secretary is to issue an order that a modified risk tobacco product may be commercially marketed only if the Secretary determines that an applicant has demonstrated that such product, as it is actually used by consumers, will:

a)     Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and

b)    Benefit the health of the population as a whole including users and nonusers of tobacco.

Secretary is allowed to issue an order allowing the sale of a tobacco product that may not be commercially marketed as a modified risk tobacco product for five years if certain requirements are met, including that: (1) such order would be appropriate to promote the public health; and (2) issuing such an order is expected to benefit the health of the population as a whole.

Advertising and labeling.- The Secretary is to require that advertising and labeling concerning modified risk tobacco products enables the public to understand the information and its significance in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.s.911(h)(5)

Post-market Surveillance.- The Secretary is to require results of post market surveillance and studies to be submitted annually. s.911(g)(2)(C)(iii)  

Withdrawal of Authorization.- The Secretary may withdraw authorization for allowing sale if the conditions stipulated are not complied with s.911(j).

Testing Regulations.- The Secretary, acting through the Commissioner of FDA, is required to promulgate regulations under this Act within 3 years that require the testing and reporting of tobacco product constituents, ingredients, and additives that the Secretary determines should be tested to protect the public health. The Secretary is furnished with the authority to conduct or require the testing, reporting, or disclosure of tobacco product constituents. The imposition of such testing regulations on small tobacco product manufacturers is delayed till the end of a 2 year period following the final promulgation of these rules. A further period of 4 years is given to the small tobacco manufacturers for testing and reporting all of its tobacco products (s.915)

User Fees.- The Secretary is required to assess a quarterly user fee on manufacturers and importers of tobacco products based on the class of tobacco product and the company market share to pay for the costs of tobacco regulation activities. The fees shall be assessed and collected with respect to each quarter of each fiscal year. FDA funds (excluding user fees) used before October 1, 2009, on such activities be reimbursed. (s.919)