SUBJECT  : Guidelines for the Authorization of Vaporized Nicotine and Non -
Nicotine Products and Novel Tobacco Products with Medicinal or 
Therapeutic Claims or Reduced -Risk Statements Pursuant to 
Sections 12 (k), 12 (l), and 13 (c) of Republic Act No. 11900  
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I. RATIONALE  3 
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Article II, Section 15 of the 1987 Constitution expressly declares as a policy of the 5 
State to “protect and promote the right to health of the people and instil health 6 
consciousness among them”. Pursuant to the above policy, Republic Act  (RA) No. 7 
11900 or the Vaporized Nicotine and Non -Nicotine Products Regulation Act adopted 8 
as a state policy to enact a balanced policy whereby these novel consumer products are 9 
properly regulated using internationally accepted product standards in order to pr otect 10 
the citizens from the hazards of regulated, unregulated and substandard Vapor 11 
Products and Heated Tobacco Products.  12 
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For this purpose, the government shall regulate the importation, assembly, 14 
manufacture, sale, packaging, distribution, use, advertisement, promotion and 15 
sponsorship of Vaporized Nicotine and Non -Nicotine Products  (VNNPs) , and their 16 
devices, and Novel Tobacco Products  (NTPs)  in order to promote a healthy 17 
environment, protect the citizens from any potential hazards of these novel  consumer 18 
products, reduce the harm caused by smoking, and ensure that the sale to minors and 19 
the illicit trade of Vaporized Nicotine and Non -Nicotine Products, and their devices, 20 
and Novel Tobacco Products in the country are prevented.  21 
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Under Sections 12 (k), 12 (l), and 13 (c) of RA No. 11900  and its implementing rules 23 
and regulations (IRR), through Department Administrative Order No. 22 -16, VNNPs 24 
and NTPs bearing  explicit medicinal or therapeutic claims, or reduced -risk statements 25 
shall require approval from the Food and Drug Administration (FDA) pursuant to R A 26 
No. 9711 otherwise known as the “Food and Drug Regulation Act of 2009”.  27 
 28 
In view of the foregoing, the FDA hereby issues the guidelines for the authorization of 29 
VNNPs or NTPs intending to make medi cinal or therapeutic claims  on its marketing 30 
materials or packaging , or explicit reduced -risk statements pursuant to RA No. 11900 31 
and its IRR.  32 
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II. OBJECTIVES  35 
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Option 1  37 
This issuance aims to provide  the guidelines on the FDA’s regulatory framework for 38 
the issuance of authorizations for VNNPs and NTPs that are marketed with medicinal 39 
or therapeutic claims  on its marketing materials or packaging , and/or explicit reduced - 40 
risk statements pursuant to RA No.  11900  and its IRR .  41 
 42 Optio n 2 43 
This issuance aims to establish guidelines for seeking approval from the FDA prior to 44 
making explicit Reduced Risk Statements in the marketing materials or packaging of 45 
VNNPs or NTPs in order to protect consumers against misleading or deceptive 46 
Reduced  Risk Statements.  47 
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III. SCOPE  50 
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Option 1  52 
This issuance shall apply to all  establishments engaged or intending to engage in the 53 
manufacture or importation  of VNNPs and NTPs with medicinal or therapeutic claims  54 
on its marketing materials or packaging , or explicit  reduced -risk statements in the 55 
country.  56 
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Option 2  58 
This issuance shall cover manufacturers, traders and importers of VNNPs and NTPs 59 
that propose to make explicit Reduced Risk Statements as defined herein in the 60 
packaging, product label or marketing materials of such products.  61 
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IV. DEFINITION OF TERMS  64 
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For the purpose of this issuance, the term are hereby defined:  66 
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A. Authorization -  refers to a permission embodied in a document granted by the 68 
FDA to a natural or juridical person who has submitted an application to 69 
implement the manufacture, importation, exportation, sale, offer for sale, 70 
distribution, transfer, and/or, where appropriate, the use, testing, promotion, 71 
advertising, or sponsorship of health products. The authorization can take the 72 
form of  a permit, a license, a certificate of registration, of accreditation, of 73 
compliance, or of exemption, or any similar document.  74 
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B. Establishment - refers to a sole proprietorship, a partnership, a corporation, an 76 
institution, an association, or an organization engaged in the manufacture or 77 
importation, offer for sale, distribution, donation, transfer, use, testing, 78 
promotion, advertising, or sponsor ship of tobacco products including the 79 
facilities and installations needed for its activities.  80 
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C. Health Claim  - refers to medicinal or therapeutic claims which are explicit 82 
statements made on any product presented as having properties for directly 83 
treating,  curing, alleviating, or preventing diseases or disorders in persons   84 
 85 D. Heated Tobacco Products (HTPs)  - also referred to as Heated Tobacco Product 86 
(HTP) Consumables or Heat -Not-Burn Product Consumables, shall refer to 87 
tobacco products that are intended to be consumed through heating tobacco, 88 
either electronically or through other means, sufficient to release an aerosol that 89 
can be inhaled, without combustion of the tobacco. HTP Consumables or Heat - 90 
Not-Burn Product Consumables may also include liquid solutio ns and gels that 91 
are part of the product and are heated to generate an aerosol. HTPs may or may 92 
not operate by means of an HTP Device;  93 
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D. Importer - refers to any establishment that imports raw materials, active 95 
ingredients and/or finished products for whole sale distribution to other local 96 
FDA -licensed establishments  97 
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E. Manufacturer - refers to any establishment engaged in any and all operations 99 
involved in the production of health products including preparation, processing, 100 
compounding, formulating, filling, packing, repacking, altering, ornamenting, 101 
finishing, and labeling with the en d in view of its storage, sale or distribution: 102 
Provided, that the term shall not apply to the compounding and filling of 103 
prescriptions in drugstores and hospital pharmacies. A trader shall be categorized 104 
as a manufacturer.  105 
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F. Medicinal or Therapeutic Claims  - refers to explicit statements made on any 107 
product presented as having properties for directly treating, curing, alleviating, 108 
or preventing diseases or disorders in persons;  109 
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G. Novel Tobacco Products (NTPs) - refers to all non -combusted substances in 111 
solid  or liquid form, and innovations, either made partly of tobacco leaf as raw 112 
material or containing nicotine from tobacco, intended to be used as a substitute 113 
for cigarettes or other combusted tobacco products;  114 
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H. Product - shall refer to VNNPs and NTPs as de fined in this issuance.  116 
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I. Post-Marketing Surveillance (PMS) - refers to activities involved in safety, 118 
efficacy, and quality monitoring of regulated products and establishments. This 119 
shall also include, among others, adverse events reporting, product safety  update 120 
reporting, collection and testing of health products in the market.  121 
   122 
J. Reduced Risk Statement - refers to an explicit communication to consumers in 123 
the product label or marketing materials which states that the product presents 124 less risk of harm to  the user's health or is less harmful to the user's health than 125 
continued smoking of combustible cigarettes;  126 
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K. Reduced Risk Statement Authorization (RRSA)  - refers to a document issued 128 
by the appropriate regulatory authority in more mature jurisdictions to a 129 
company, firm or non -profit organization as an authorization to market products 130 
with Reduced Risk Statements in countries such as [insert name of the c ountry]  131 
 132 
K. Trader - refers to an establishment that is a registered owner of a health product, 133 
procures the raw materials and packing components, provides the production, 134 
monographs, quality control standards, and procedures, but subcontracts the 135 
manufacture  of such a product to a licensed Manufacturer. In addition, a trader 136 
may also engage in the distribution and/or marketing of its products.  137 
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L. Vapor Products  - also referred to as Vapor Product Refills, refer to the liquid, 139 
solid, or gel, or any combination t hereof, which may or may not contain nicotine, 140 
that is transformed into an aerosol without combustion by a Vapor Product 141 
Device  142 
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M. Vaporized Nicotine or Non -Nicotine Products  (VNNPs) - refers to both 144 
Heated Tobacco Products and Vapor  Products, as defined herein, which are 145 
novel consumer goods that generate a nicotine -containing or non -nicotine - 146 
containing aerosol without combustion.  147 
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V. GENERAL GUIDELINES  150 
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A. The FDA shall issue the operational guidelines for Section 12 (k), 12 (l) and 152 
Section 13 (c) of RA No. 11900, including the appropriate standards and 153 
requirements, and oversee its implementation and enforcement.   154 
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B. Establishments (manufacturers, importers, traders) that have secured the 156 
required authorizations to market VNNPs and NTPs with explicit medicinal or 157 
therapeutic claims, and/or reduced -risk statement in the country shall ensure 158 
continuous compliance with existing laws as well as with regulations, applicable 159 
standards, and conditions set forth for such products.  160 
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C. Only VNNP s and NTPs that have secured the appropriate authorizations shall be 162 
allowed to be marketed with explicit medicinal or therapeutic claims, and/or 163 
reduced -risk statements in the country. More particularly, only the medicinal or 164 therapeutic claims, and/or re duced -risk statement approved for use shall be 165 
placed on the product label or marketing materials .  166 
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D. The agency shall observe the necessary requisites in its policy development and 168 
ensure the right to health of the Filipino. All personnel and officials sha ll strictly 169 
abide by the agency’s policies on conflict of interest and rules of engagement 170 
when interacting with the regulated establishments and their representatives.  171 
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VI. SPECIFIC GUIDELINES  174 
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Option 1  176 
A. ON COMMUNICATING REDUCED RISK STATEMENTS  177 
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Manufacturers, distributors, and importers of VNNPs and NTPs proposing to 179 
make explicit Reduced Risk Statements shall undergo the Reduced Risk 180 
Statement Authorization (RRSA) application process if Reduced Risk 181 
Statements are to be made on the packaging, pr oduct label or in marketing 182 
materials of VNNPs or NTPs.  183 
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1. A Reduced Risk Statement may only  be made if authorized by the FDA in 185 
accordance with the procedure laid down under this section and following 186 
the application process provided for under Appendix A of  this issuance . 187 
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2. The FDA shall, with respect to an application submitted under this section, 189 
issue a RRSA order that a Reduced Risk Statement may be used in the 190 
relevant material only if the FDA determines that the statement is 191 
appropriately substantiated and the manufacturer has demonstrated that 192 
such product, as it is actually used by consumers, will:  193 
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a. significantly reduce harm and the risk of smoking related disease to 195 
individual product users; and  196 
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b. benefit the health of the population as a whole taking into account both 198 
smokers and persons who do not currently smoke.  199 
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3. In making determinations under V.2.a above, the FDA shall take into 201 
account the relative health risks to individuals of the Product compared to 202 
the use of cigarettes;  203 
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4. Applications subject to an order under V.2.a shall be limited to a term of 205 
not more than five (5) years from the issuance of the RRSA Order, but may 206 
be renewed upon a finding by the FDA that the requirements of this section 207 
continue to be satisfied based on the filing of a new  application.  208 
 209 5. Each applicant who receives RRSA Order must conduct post market 210 
surveillance and studies to identify and collect information on the effect of 211 
the issuance of the order on consumer perception, behavior, and health, 212 
including unanticipated and  undesired events related to the VNNPs and 213 
NTPs once it is introduced to the market. Applicants granted a RRSA 214 
Order must submit protocols for required post market surveillance for FDA 215 
concurrence within 60 days after receiving notice that they are require d to 216 
conduct such surveillance. All applicants granted RRSA Order must 217 
submit the results of post market surveillance annually, which shall not be 218 
later than the end of the second calendar month of the following year.  219 
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6. Reduced Risk Statements which are aut horized, validated, accepted, or 221 
permitted by reliable and mature national regulatory agencies for VNNPs 222 
and NTPs shall be taken into consideration by the FDA in its resolution of 223 
an application for a RRSA Order and shall be resolved within a non - 224 
extendibl e period of 6 months. This abbreviated procedure for authorizing 225 
Reduced Risk Statements shall only proceed after determination by the 226 
FDA that the Product from the same manufacturer (1) has the same 227 
characteristics as another product for which the claim h as been authorized; 228 
or (2) has different characteristics but does perform similarly.   229 
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7. The RRSA Order issued shall remain valid unless otherwise revoked, upon 231 
due process, by the FDA in light of new scientific evidence that expressly 232 
invalidates the exist ing Reduced Risk Statement being used by a Product. 233 
RRSA Order shall only be revoked after due notice and hearing has been 234 
given to the manufacture, trader or importer.  235 
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8. The final disposition on the Reduced Risk Statements application 237 
evaluations issued by  the Director General of the FDA is subject to re - 238 
examination upon written request of the applicant. The applicant shall give 239 
written notice to the Director General of the FDA that said applicant 240 
wishes to request a re -examination within 15 days of receipt  of the 241 
disposition. The grounds for the re -examination request must be forwarded 242 
to the FDA within 60 days of receipt of the disposition.  243 
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9. Under no circumstances shall evaluations with favorable dispositions be 245 
deemed to mean that VNNPs and NTPs subject o f the application are safe. 246 
Any industry promotion, advertisement, or communication, explicit or 247 
implicit, indicating that the product is “FDA approved” shall be grounds 248 
for immediate and final denial of active VNNPs and NTPs applications 249 
associated with t he offender’s Reduced Risk Statement application.  250 
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  252 Option 2  253 
1. Evidence for reduced -risk statements shall be evaluated on a per product 254 
basis, and shall follow the current rules and regulations for the 255 
authorization of drug products and its industries.  256 
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2. Products which are authorized, validated, accepted, or permitted by 258 
reliable and mature national regulatory agencies to be marketed with 259 
reduced -risk statements shall be taken into consideration by the FDA in its 260 
resolution of an application for an authori zation and shall be resolved 261 
within eighteen (18) months; and  262 
 263 
3. The FDA shall review the current regulatory framework, and assess other 264 
processes that may be considered as more suitable for the authorization of 265 
products with reduced -risk statements.  266 
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4. Subject to the results of the review of the current regulatory framework, 268 
the FDA may consider the issuance of a separate implementing guidelines 269 
for the authorization of products that are marketed with explicit reduced - 270 
risk statements, including the condu ct of post -market surveillance and 271 
adverse event reporting in accordance with Department Order No. 2015 - 272 
0284 entitled “Revised Rules and Procedures on the Preparation and 273 
Approval of Administrative Issuances in the Department of Health” and 274 
other pertinent  issuances.  275 
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5. In the development of new guidelines, the FDA shall consider a weight of 277 
evidence approach based on a comprehensive scientific assessment that 278 
may include but not limited to the following;  279 
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a. Conduct of a thorough literature search, literature q uality assessment, 281 
evidence synthesis to assess causality for health effects, application of 282 
a framework for levels of evidence affected by user behaviour, and 283 
short and long -term health effects.  284 
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b. Studies that show significantly reduced harm and the risk o f smoking 286 
related   disease to individual product users;  287 
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c. Benefit the health of the population as a whole taking into account 289 
both smokers and persons   who do not currently smoke; and  290 
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d. Other important parameters such as exclusive and poly -use, etc.  292 
 293  294 
B. ON COMMUNICATING HEALTH CLAIMS  295 
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Option 1  297 
No VNNPs or NTPs shall have a medicinal or therapeutic claim on its marketing 298 
or labelling materials, such as “this product is safe” or “is an effective smoking 299 
cessation device” unless such claim is approved by the FDA pursuant to 300 
Republic Act No. 3720, as amended.  301 
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Option 2  303 
Products that will have medicinal or therapeutic claims on its marketing or 304 
labelling materials  such as but not limited to for smoking cessation shall follow 305 
the prescribed existing rules and reg ulations for drug products.  306 
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VII. FEES  309 
 310 
TBD  311 
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VIII.  ENFORCEMENT ACTION AGAINST FALSE OR NOT SCIENTIFICALLY 313 
SUBSTANTIATED FORMS OF CONSUMER COMMUNICATION  314 
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Violation of any provisions of this issuance  shall be subject to the penalties/sanctions 316 
provided under RA 11900 and its Implementing Rules and Regulations and other 317 
penalties provided by other applicable laws. In addition, the FDA shall take all 318 
appropriate measures to prohibit the marketing or use  of unsubstantiated or false 319 
claims and the withdrawal from the market of the subject products.  320 
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IX. MANDATORY REVIEW  323 
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This issuance shall be reviewed three (3) years after its implementation date or earlier 325 
as may be necessary.  326 
 327 
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X. PENALTIES  329 
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Violation to any provisions of this issuance shall be subject to the penalties/sanctions 331 
provided under Book III, Article XI of the Rules and Regulations Implementing 332 
Republic Act No. 9711, The Food and Drug Administration Act of 2009, Republic Act 333 
No. 119 00, and other penalties provided by other applicable laws.  334 
 335 
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XI. SEPARABILITY CLAUSE  337  338 
If any provision in this issuance, or application of such provision to any circumstances, 339 
is held invalid, the remainder of the provisions in this issuance shall not be affec ted. 340 
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XII. EFFECTIVITY  343 
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This issuance shall take effect fifteen (15) days after publication to the Official Gazette 345 
or a newspaper of general circulation, with three (3) copies to be filed with the U.P. 346 
Law Center pursuant to Section 3, Chapter 3, Book VII of Executive Order No. 292, 347 
Series of 1987 through this Department’s records officer or its equivalent functionary.  348