Overview Questions: Substantial Equivalence

 

What is substantial equivalence?

Substantial equivalence is a regulatory pathway through which a new tobacco product may be commercially marketed in the United States.

Substantial equivalence is a regulatory term defined in Section 910(a)(3) of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).   It has specific meaning with respect to tobacco products and differs from substantial equivalence in other regulatory contexts.
 

What is a new tobacco product?

A new tobacco product is defined (Section 910(a)(1)) of the Tobacco Control Act as:

1. “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or”
2. “any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.” 
   (NOTE: It is important to point out that the law defines a ‘new tobacco product’ to include a modification of a tobacco product where the modified product is commercially marketed after February 15, 2007.)
    

What is a tobacco product?

Tobacco product means “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).” (section 201(rr)(1))
 

To what products does substantial equivalence apply?

All new tobacco products regulated by the Food and Drug Administration (FDA) are subject to these provisions.  Currently, FDA’s Center for Tobacco Products (CTP) regulates cigarettes, roll-your-own, and smokeless tobacco products.  However, the law permits FDA to deem other tobacco products to be subject to the Tobacco Control Act through rulemaking.
 

What is a modification for purposes of determining whether a product is a new tobacco product?

The Tobacco Control Act defines a modification of a tobacco product to include a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient of a tobacco product.  (section 910(a)(1)(B))
 

What is an additive?

This term is defined in the Tobacco Control Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical described in section 900(1) of the Act.

 

How does the Tobacco Control Act define substantial equivalence?

“Substantially equivalent” or “substantial equivalence,” as defined by Section 910(a)(3)(A) of the Tobacco Control Act, refers to a product that:

1. “Has the same characteristics as the predicate tobacco product; or”
2. “Has different characteristics and the information submitted [in a Substantial Equivalence Report] contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under [the new tobacco product application provisions of section 910(c)] because the product does not raise different questions of public health.” 
    

What is a predicate tobacco product?

In its guidance, FDA interprets a predicate to mean a single tobacco product to which the manufacturer intends to show that its new tobacco product is substantially equivalent.
 

What can I use as a predicate product for my Substantial Equivalence Report?

A predicate product may be either:

1. a tobacco product commercially marketed as of February 15, 2007 that has not been modified or
2. a tobacco product that FDA has determined to be substantially equivalent to a tobacco product commercially marketed as of February 15, 2007 and in compliance with the requirements of the Act.

 

Who may submit a Substantial Equivalence Report?

A manufacturer of a new product may submit a Substantial Equivalence Report.  A new tobacco product is defined at section 910(a)(1) as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.”
 

How may a manufacturer legally market a new tobacco product in the United States? 

There are three regulatory pathways by which a manufacturer may legally market a new tobacco product in the United States:

• Submit to FDA a premarket application under section 910(c) and obtain an order authorizing marketing of the new tobacco product (section 910(c))
• Submit to FDA a Substantial Equivalence Report and obtain an order finding the product to be substantially equivalent to a predicate tobacco product (section 910(a)(2))
• Submit to FDA a request for an exemption from the Substantial Equivalence requirements and obtain an exemption (section 905(j)(3))
   

Whose responsibility is it to know when a product was first commercially marketed?

It is the responsibility of the manufacturer to know and to be able to document when its products were introduced into the marketplace.   
 

Why is February 15, 2007 relevant?

This is the date set forth by Congress in the Tobacco Control Act which determines whether or not a tobacco product is considered “new” and subject to review by the FDA.
 

What if my product was commercially marketed on February 15, 2007?

If the product was commercially marketed on February 15, 2007 and has not had any modifications (i.e., a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient of a tobacco product) since then, the product is not considered a new tobacco product under the Tobacco Control Act.

 

What if my new tobacco product was not commercially marketed on February 15, 2007 but was commercially marketed between February 15, 2007 and March 22, 2011?

If the product was first commercially marketed between February 15, 2007 and March 22, 2011, a manufacturer must submit a Substantial Equivalence Report to the FDA by March 22, 2011 for its product to remain on the commercial market while FDA completes its review of the Substantial Equivalence Report.

For tobacco products first commercially marketed during this time that are submitted by March 22, 2011, FDA intends to allow manufacturers who have acted diligently in preparing their submissions a reasonable amount of time to supplement their initial submissions, provided these manufacturers submit their Substantial Equivalence Report by the March 22, 2011 deadline.

Failure to submit a Substantial Equivalence Report by the March 22, 2011 deadline renders the product adulterated under section 902(6) of the Act and misbranded under section 903(6) of the Act. 

Description of Chart

What happens once a Substantial Equivalence Report is submitted to FDA

Once a Substantial Equivalence Report is submitted, the FDA will review it and issue either an order of substantial equivalence or an order stating that the product is not substantially equivalent.  An order of substantial equivalence allows the product to be commercially marketed.  A tobacco product may not be commercially marketed if you receive an order stating your product is not substantially equivalent. (section 910(a)(2))

 

What happens if I receive an order stating my product is not substantially equivalent?

In that case, you may not commercially market your product.  For products currently on the market, this means you must remove the product from market.  (section 910(a)(2))  A manufacturer whose product is found to be not substantially equivalent may submit an application for marketing authorization under the premarket tobacco product application provisions of the Act. (section 910(c))

 

What happens if FDA does not receive a Substantial Equivalence Report for a new tobacco product (please make sure to review the definition of ‘new tobacco product,’ above) that is commercially marketed?

The product is deemed adulterated under section 902(6) of the Act and misbranded under section 903(6) of the Act, and is subject to regulatory action. 

 

What is a reasonable amount of time for manufacturers to supplement their submissions?

The guidance states that FDA will determine this on a case-by-case basis. 

 

If FDA determines a product is substantially equivalent, does that mean the product is safe, or safer than its predicate product?

No. There is no known safe tobacco product.  All that means is that FDA has made a finding that the new tobacco product has the same characteristics as the predicate tobacco product, or that it has different characteristics, but the manufacturer submitted information to demonstrate that it is not necessary to regulate the product under the new tobacco product application provisions because the product does not raise different questions of public health.