We have been requested by Nasutra™ LLC to review the regulatory status for the above dietary supplement product for compliance with the Federal Food, Drug, and Cosmetic Act (FDC Act) and regulations enforced by the Food and Drug Administration (FDA).

1. EXPERIENCE OF THIS FIRM

Our law firm generally confines its position to assisting corporations and other law firms in matters involving: (1) the regulation of foods, drugs, medical devices, and cosmetics by FDA under the FDC Act; or, (2) the regulation of the same type of products by other federal, state or international agencies.

My own practice includes 15 years as general counsel in charge of legal and regulatory affairs for a company extensively regulated by FDA, three years as the west coast regulatory partner of Hyman, Phelps & McNamara, a Washington, D.C. based law firm with the largest food and drug practice in the United States and 12 years as a sole practitioner specializing in FDA regulatory matters. I am licensed as a registered pharmacist and attorney and admitted to practice law and pharmacy in the states of California and Michigan.

2. LEGAL REVIEW - DIETARY SUPPLEMENT HEALTH & EDUCATION ACT OF 1994 (DSHEA)

A. Title
The law affecting the sale of dietary supplements is officially named the "Dietary Supplement Health and Education Act" (DSHEA). Its provisions are amendments to the FDC Act, adding to changes in the FDC Act begun by the Nutrition Labeling and Education Act of 1990 (NLEA).

B. Definition of "Dietary Supplement"
A dietary supplement is defined as a "product . . . intended to supplement the diet that bears or contains one or more of" certain specified "dietary ingredients." These include "a vitamin," "a mineral," "an herb or other botanical," "an amino acid," "a dietary substance for use by man to supplement the diet by increasing the total dietary intake," and "a concentrate, metabolite, constituent, extract, or combination" of any of the foregoing ingredients.

This law settles a fundamental definitional matter by providing a broad, expansive definition of "dietary supplement," to include even products that FDA nutritionists would regard as not having any nutritional value.

A dietary supplement must either be in the form of a tablet, capsule, powder, softgel, gelcap, or liquid form that is not "represented" as "a conventional food."

C. Dietary Supplements Deemed To Be Foods
The DSHEA provides that, "[e]xcept for purposes of section 201(g), a dietary supplement shall be deemed to be a food." This will normally prevent FDA from arguing that a product that otherwise meets the requirements of law as a dietary supplement is nevertheless not a food, because it is not used primarily for its taste, aroma, or nutritional value.

D. Exemption From "Food Additive" Status

One of the most important improvements of this law is that it provides that the term "food additive" no longer applies to a dietary ingredient in, or intended for use in, a dietary supplement.

Under the FDC Act, a substance added to or likely to become a component of a food that is not "generally recognized as safe" (not GRAS), by "experts," based on published scientific literature, is subject to regulation as a "food additive," which means it may not be used until and unless FDA issues a regulation explicitly permitting such use.

In the past, FDA has frequently alleged "unapproved food additive" status against many popular dietary supplement ingredients. This law eliminates that risk for dietary ingredients used in dietary supplements.

E. New Safety Standards

The trade-off, however, is that this law replaces the food additive provisions with some new safety standards for dietary supplements.

The DSHEA provides that a dietary supplement may be "adulterated" if it "presents a significant or unreasonable risk of illness or injury under . . . conditions of use recommended or suggested in labeling, or . . . if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use." The dietary supplement law expressly states that FDA "shall bear the burden of proof" in court if it asserts that a dietary supplement is adulterated under this standard.

There are additional requirements for a dietary ingredient, i.e., an ingredient that was not marketed in the United States before October 15, 1994 or was not present in the food supply as an article used for food in a form in which the food has not been chemically altered.

F. Statements of Nutritional Support

The NLEA provides that no "health claim" may appear in the labeling of food products, including dietary supplements, unless FDA has first approved use of the claim in a regulation. A "health claim" is one that "characterizes the relationship of any nutrient . . . to a disease or a health-related condition." This law and FDA's implementing regulations still apply to dietary supplements.

But the DSHEA spells out an exception for dietary supplements to the general requirements for FDA approval of health claims for four types of "statements of nutritional support." These four types of statements include:

1. A "statement [that] claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States."

2. A statement that "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans."

3. A statement that "characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function."

4. A statement that "describes general well-being from consumption of a nutrient or dietary ingredient."

The law provides that such a statement may be made in labeling if:

1. The manufacturer "has substantiation that such statement is truthful and not misleading";

2. The labeling contains, prominently displayed, the following additional text: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease"; and

3. The manufacturer notifies FDA "no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.

3. ANALYSIS

A. Background
We understand that Nasutra™ LLC is interested in marketing a new dietary supplement product identified as Nasutra™ for sexual stamina and endurance health related benefits. The product will be made from a highly concentrated extract of 10 Chinese herbs identified as: Cynomorium songaricum, Atractylodes macrocephalia, Lycium barbarum, Epimedium sagittatum, Rehmannia glutinosa, Schisandra chinensis, Polygonum multiflorum, Cinnamonum aromaticum, Amomum villosum, Panax ginseng. All these herbal ingredients have been used extensively, and are well characterized and listed in the "Herbs of Commerce," 1992 edition. See 21 CFR Section 101.4(h).

The Nasutra™ formulation has been studied extensively in China to demonstrate safety and efficacy for sexual health benefits. We have also reviewed documentation and Analysis Certificates provided by Nasutra™ LLC confirming that the herbal ingredients in the Nasutra™ product have been previously analyzed by HPLC and other laboratory methods to show that they are natural extracts with no added ingredients including hormones and synthetic drugs such as sildenafil (Viagra®) or apomorphine.

B. Nasutra™ Dietary Supplement Status
We understand that the dietary supplement product Nasutra™ will consist of the ten herbal ingredients discussed above and have label claims that the product will "generate harder erections, increase sexual stamina and endurance, and greatly reduce the recovery time between sexual intervals" and will be identified on the label as a dietary supplement.

We have reviewed the dietary ingredients and proposed labeling claims for Nasutra™ and find that its intended use is consistent with the definition of a dietary supplement provided by Section 201(ff) of the FDC Act (21 U.S.C. § 321(ff)). The ingredients contained in Nasutra™ are all herbal dietary ingredients that are included within the broad legal definition of a dietary supplement. See 21 U.S.C. § 321(ff)(1)(C) and (F).

As discussed above, Section 6 of DSHEA added a paragraph 6 to Section 403(r) of the FDC Act (i.e. the health claims section of NLEA) which provides for four types of nutritional support claims. The second type of claim relates to structure and function claims. Section 403(r)(6) of the FDC Act permits a label statement for a dietary supplement product to be made if it characterizes the role of a nutrient or dietary ingredient that is intended to affect the structure or function of humans.

Section 403(r)(6)(B) and (C) of the FDC Act requires a manufacturer that includes a structure and function claim in its product labeling to have substantiation that the claim is truthful and not misleading and that the statement contains prominently and in bold face the following: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." A manufacturer is further required to notify FDA of the use of the claim no later than 30 days after first marketing of the dietary supplement labeled with the claim.

FDA has issued a final regulation at 21 CFR Section 101.93(f) and (g) regarding "Statements made for dietary supplements concerning the affect of a product on the structure or function of the body." Our research of this regulation and FDA's preamble discussion in the Federal Register when the regulation was issued suggests that FDA considered "arouses or increases sexual desire," "improves sexual performance," and "decreases sexual function associated with aging" to be acceptable structure/function claims because those claims do not imply a disease but natural function of the body. We would consider the Nasutra™ dietary supplement label claims to be structure/function claims allowed by Section 403(r)(6) of the FDC Act and consistent with the position of FDA on several function type claims.

We and other Nasutra™ LLC experts have reviewed the clinical studies conducted in China on the Nasutra™ formulation that provide scientific support and clinical substantiation for the structure/function claims contained in the labeling for Nasutra™. We have further reviewed the Nasutra™ product label and find it in compliance with the labeling requirements for dietary supplements specified in an FDA regulation at 21 CFR Section 101.36.

We intend to instruct and assist Nasutra™ LLC in sending FDA the thirty (30) day post-marketing notice also required by Section 403(r)(6)(c) of the FDC Act and the FDA regulation at 21 CFR § 101.93(a) and (b).

4. CONCLUSION

In summary, it is our opinion, based on a review of the herbal ingredients, formulation, product label and labeling claims, and other documents provided by Nasutra™ LLC, that the marketing of the Nasutra™ product would be consistent with its regulatory status as a dietary supplement under the FDC Act and regulations enforced by FDA.