3

Exhibit “A”

Rosas, et al., v. Hi-Tech Pharmaceuticals

cv 20-004433-DOC-DRM

D.E. 46, Order Re: Motion to Dismiss [13]

__________________________________

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UNITED STATES DISTRICT COURT 

CENTRAL DISTRICT OF CALIFORNIA 

SOUTHERN DIVISION 

CRISTIAN ROSAS ET AL., 

Plaintiffs, 

 v. 

HI-TECH PHARMACEUTICALS, 

 Defendant. 

Case No.: CV 20-00433-DOC-DFM 

ORDER RE: MOTION TO DISMISS 

[13]

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Before the Court is Defendant Hi-Tech Pharmaceuticals, Inc.’s (“Defendant”) Motion to 

Dismiss (“Motion”) (Dkt. 13). The Court finds this matter appropriate for resolution without 

oral argument. See Fed. R. Civ. P. 78; C.D. Cal. R. 7-15. For the reasons stated below, the Court 

GRANTS Defendant’s Motion. 

I. Background

A. Factual Background

Plaintiffs Cristian Rosas, Ralph Milan, and Tanner Ayoob (collectively, “Plaintiffs”) 

purchased dietary supplemental products from Defendant that allegedly contain ingredients not 

safe for human consumption. See Compl. (Dkt. 1) ¶¶ 2, 19. Specifically, Plaintiffs purchased 

the following: “Mesomorph Pre-Workout,” “DMAA Enhanced – Off the Chain Aminos,” 

“HydroxyElite,” and “Lipodrene: With 25mg Ephedara Extract” (collectively, the “Products”). 

Id. The products contain the ingredients 1,3-dimethylamylamine (“DMAA”), 

dimethylhexylamine (“DMHA”), and methylsynephrine. Id. ¶ 19. 

DMAA and DMHA were originally developed for use in nasal decongestants, but their 

consumption has been shown to increase the uptake of dopamine and noradrenaline. Id. ¶ 20. 

Methylsynephrine is a stimulant used in pre-workout supplements that increases blood pressure 

and heart rate, but may cause nausea, vomiting, agitation, or cardiac arrest. Id. ¶ 21. The Food 

and Drug Administration (“FDA”) considers DMAA, DMHA, and methylsynephrine not safe 

or approved for human consumption.1 Id. ¶ 3. 

The FDA issued a warning letter to Defendant on April 10, 2019 about its products that 

contain the ingredient DMHA. See Motion (“Mot.”) (Dkt. 13) at 11:20. The FDA notified 

Defendant of the following: 

To the best of FDA’s knowledge, there is no information demonstrating that 

DMHA was lawfully marketed as a dietary ingredient in the United States before 

1 See DMAA in Products Marked as Dietary Supplements, U.S. Food & Drug Administration (Aug. 7, 2018), 

https://www.fda.gov/food/dietary-supplement-products-ingredients/dmaa-products-marketed-dietarysupplements; DMHA in Dietary Supplements, U.S. Food & Drug Administration (Apr. 19, 2019), 

https://www.fda.gov/FOOD/DIETARY-SUPPLEMENT-PRODUCTS-INGREDIENTS/DMHA-DIETARYSUPPLEMENTS; Methylsynephrine in Dietary Supplements, U.S. Food & Drug Administration (Nov. 29, 2017), 

https://www.fda.gov/food/dietary-supplement-products-ingredients/methylsynephrine-dietary-supplements. 

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October 15, 1994, nor is there information demonstrating that this ingredient has 

been present in the food supply as an article used for human food in a form in 

which the food has not been chemically altered. . . . In the absence of a history of 

use or other evidence of safety establishing that DMHA . . . will reasonably be 

expected to be safe, dietary supplements containing DMHA as a new dietary 

ingredient are adulterated. . . . Adulterated foods cannot be legally . . . marketed in 

the United States. . . . You should take prompt action to correct the violations 

addressed in this letter. . . . Failure to immediately cease distribution of your 

products . . . that contain DMHA, could result in enforcement action by the FDA 

without further notice. 

See Declaration of Theodora McCormick (“McCormick Declaration”) (Dkt. 13), Ex. A at 39-

40. The FDA has issued similar warning letters to manufacturers who use DMAA and 

methylsynephrine in their products. See, e.g., Letter from Food and Drug Administration to SEI 

Pharmaceuticals (April 12, 2012) (on file with the Food and Drug Administration); Letter from 

Food and Drug Administration to Cordy Hooten, Chief Exec. Officer, Chaotic Labz (Mar. 31, 

2016) (on file with the Food and Drug Administration). 

 Defendant challenged the FDA’s attempt to ban DMHA in the District Court for the 

District of Columbia (“D.C. Action”), alleging it did not engage in the proper rulemaking 

process necessary to formally ban DMHA. See McCormick Decl., Ex. B ¶¶ 40-41. The District 

Court for the District of Columbia dismissed Defendant’s case on June 29, 2020 because the 

FDA’s warning letter did not constitute final agency action subject to judicial review. See

Suppl. Authority (Dkt. 32) at 8. 

B. Procedural Background 

On March 3, 2020, Plaintiffs filed a class action complaint pleading five causes of 

action: (1) violation of California’s Consumer Legal Remedies Act (“CLRA”), (2) violation of 

California’s False Advertising Law (“FAL”), (3) violation of California’s Unfair Competition 

Law (“UCL”), (4) negligent misrepresentation, and (5) intentional misrepresentation. See 

generally Compl. Defendant filed the instant Motion to Dismiss Plaintiffs’ claims under the 

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doctrine of primary jurisdiction, among other grounds. On June 8, 2020, Plaintiffs filed their 

Opposition (Dkt. 15), and Defendant submitted its Reply (Dkt. 26) on June 22, 2020. Plaintiffs 

and Defendant also filed supplemental briefs (Dkts. 35 and 36, respectively) in response to the 

dismissal of the D.C. Action. 

II. Legal Standard 

The primary jurisdiction doctrine allows a court to either stay proceedings or to dismiss 

a complaint without prejudice “pending the resolution of an issue with the special competence 

of an administrative agency.” Clark v. Time Warner Cable, 523 F.3d 1110, 1114 (9th Cir. 

2008). When exercising the doctrine, the court determines that “an otherwise cognizable claim 

implicates technical and policy questions that should be addressed in the first instance by the 

agency with regulatory authority over the relevant industry rather than by the judicial branch.” 

Id. (citing Syntek Semiconductor Co., Ltd. v. Microchip Tech. Inc., 307 F.3d 775, 780 (9th Cir. 

2002)). 

A district court may invoke the doctrine when a claim requires the “resolution of an 

issue of first impression, or of a particularly complicated issue that Congress has committed to 

a regulatory agency.” Brown v. MCI WorldCom Network Servs., Inc., 277 F.3d 1166, 1172 (9th 

Cir. 2002). However, it is not a doctrine that requires all claims within an agency’s purview to 

be decided by the agency. Id. Rather it is a “doctrine used by courts to allocate initial 

decisionmaking responsibility between agencies and courts where such [jurisdictional] overlaps 

and potential for conflicts exist.” Syntek, 307 F.3d at 780. Although the doctrine is 

discretionary, the Ninth Circuit has identified four factors in cases where courts have invoked 

primary jurisdiction: “(1) the need to resolve an issue that (2) has been placed by Congress 

within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a 

statute that subjects an industry or activity to a comprehensive regulatory scheme that (4) 

requires expertise or uniformity in administration.” United States v. Gen. Dynamics Corp., 828 

F.2d 1356, 1362 (9th Cir. 1987). 

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III. Discussion 

In addition to exercising primary jurisdiction, Defendant asks the Court to dismiss 

Plaintiffs’ claims for the following reasons: 

(1) The Food, Drug, and Cosmetics Act (“FDCA”) preempts Plaintiffs’ claims; 

(2) plaintiffs lack standing; 

(3) the complaint fails to sufficiently plead violations of CLRA, FAL, UCL, negligent 

misrepresentation, or intentional misrepresentation; and 

(4) decline jurisdiction under the doctrine of judicial abstention. 

See generally Mot. For the reasons discussed below, the Court need not address Defendant’s 

additional grounds for dismissal. 

 Under the doctrine of primary jurisdiction, neither party contests that the Food and Drug 

Administration (“FDA”) has regulatory authority and jurisdiction over the food industry. 

However, the parties do contend that (1) there is a need to resolve an issue that (2) requires the 

expertise of an administrative body. Specifically, Defendant claims that before Plaintiffs can 

allege any sort of false advertising claim, the FDA must have made a final agency 

determination as to whether DMAA, DMHA, and methylsynephrine are safe for human 

consumption, thereby requiring the agency’s expertise. See Reply at 8:4-11, 22-25. Plaintiffs 

contend that the FDA has already classified DMAA, DMHA, and methylsynephrine as unsafe 

for human consumption and therefore the FDA’s expertise is not required. See Opp’n at 24:10-

21. The Court addresses each issue in turn. 

A. Whether the FDA has taken final agency action to determine whether 

DMAA, DMHA, and methylsynephrine are dietary supplements safe for 

human consumption 

For an agency action to be final, (1) there must be a “consummation” of the agency’s 

decision-making process that is not tentative or interlocutory and (2) “the action must be one by 

which ‘rights or obligations have been determined,’ or from which ‘legal consequences will 

flow.’” Bennett v. Spear, 520 U.S. 154, 177-178 (1997) (citations omitted). An agency’s 

warning letters fail to satisfy either condition. Dietary Supplemental Coalition, Inc. v. Sullivan, 

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978 F.2d 560, 563 (9th Cir. 1992); see also Biotics Research Corp. v. Heckler, 710 F.2d 1375, 

1377 (9th Cir. 1983) (“‘[T]he type of informal letter issued by the FDA . . . does not constitute 

the kind of formal or final agency action the Supreme Court had in mind . . .’”) (quoting IMS 

Ltd. v. Califano, 453 F. Supp. 157, 160 (C.D. Cal. 1977)). 

Specifically, warning letters from the FDA do not mark the consummation of the 

agency’s decision-making process. FDA warning letters give “firms an opportunity to take 

voluntary and prompt corrective action before [the agency] initiates an enforcement action.” 

FOOD AND DRUG ADMINISTRATION, REGULATORY PROCEDURES MANUAL § 4-1-1 (2017). 

Violations of the FDA’s warning letters “may lead to enforcement action,” but such 

enforcement is not guaranteed. Id. 

Here, Plaintiffs allege that the FDA has addressed the issue of whether DMAA, DMHA, 

and methylsynephrine are safe for human consumption through the use of warning letters. See

Opp’n 23:8-20. Defendant claims that warning letters do not constitute final agency action. See

Reply at 9:2-10. The Court agrees with Defendant. The language in the FDA’s warning letter to 

Defendant represents neither the “consummation” of the agency’s decision-making process nor 

an action from which legal consequences will flow. For instance, the letter states that Defendant 

“should take prompt action,” not that it must. See McCormick Decl., Ex. A at 39-40 (emphasis 

added). The letter also notes that failure to cease distribution of products containing DMHA 

“could result in enforcement action,” not that it will. Id. Moreover, even if the FDA has taken 

enforcement action against Defendant, Plaintiffs’ use of warning letters to demonstrate a final 

rule or final agency action is unavailing. Cf. Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 

1033, 1037 (10th Cir. 2006) (explaining the FDA’s extensive notice and comment process to 

issue a final rule under DSHEA regulating the sale of ephedrine-alkaloid dietary supplements). 

The Plaintiff relies on Reid v. Johnson & Johnson, 780 F.3d 952, 967 (9th Cir. 2015), to 

argue that the FDA had taken final agency position through its warning letters, thereby 

rendering primary jurisdiction inappropriate. See Opp’n at 23:13-16. In Reid, the plaintiff 

brought suit against defendants Johnson & Johnson and McNeil Nutritionals, LLC for the false 

claim that their product contained “no trans. fat” when it actually did. Reid, 780 F.3d at 956. 

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However, the Ninth Circuit in Reid noted that there was already an existing FDA regulation 

specifically addressing trans fat on nutrition labels: 

If the serving contains less than 0.5 gram, the content when declared, shall be 

expressed as zero . . . if a statement of the trans fat content is not required and, as a 

result, not declared, the statement “Not a significant source of trans fat” shall be 

placed at the bottom of the table of nutrient values. 

21 C.F.R. § 101.9(c)(2)(ii). The FDA did not take a final position regarding the use of trans fat 

labels through its warning letters as Plaintiffs allege. Rather, “there [was] already an interim 

final rule on the books” from which the FDA based their warning letters. Reid, 780 F.3d at 966. 

Cf. S. Rep. No. 103-410, at 35 (1994) (Conf. Rep.) (“[When the FDA declares a dietary 

supplement adulterated under the Dietary Supplement Health and Education Act], the FDA 

would publish a notice in the Federal Register . . . setting forth the basis for their position that a 

substantial . . . risk of illness or injury is presented.”). Here, however, neither party cited a 

similar regulation nor an “interim final rule” other than the FDA’s warning letters. 

Accordingly, the Court finds that the FDA has not taken final agency action to determine 

whether DMAA, DMHA, and methylsynephrine are safe for human consumption. 

B. Whether the issue of DMAA, DMHA, and methylsynephrine being dietary 

supplements and therefore safe for human consumption requires the 

expertise of the FDA or uniformity in administration 

Classification of a product or ingredient as either a drug, biological product, or food 

involves the “determination of technical and scientific questions” best left to agency expertise. 

Biotics, 710 F.2d at 1377 (quoting Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 

654 (1973)). In such cases, a district court should decline to review “anything less than the final 

administrative determination on the classification of the product.” Dietary Supplemental 

Coalition, Inc. v. Sullivan, 978 F.2d 560, 563 (9th Cir. 1992) (citing Bentex, 710 F.2d at 1377). 

In 1994, Congress enacted the Dietary Supplement Health and Education Act 

(“DSHEA”) to clarify labeling requirements on dietary products. Dietary Supplement Health 

and Education Act, S. 784, 103rd Cong. § 1 (1994). Under DSHEA, the FDA regulates dietary 

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supplements in a manner similar to food, preventing adulterated products from entering the 

market. See 21 U.S.C. § 331(a)-(c) (prohibiting adulterated food, drug, device, tobacco product, 

or cosmetic from entering interstate commerce). 

Here, Plaintiffs claim that the Court does not need the FDA’s expertise. See Opp’n at 

24:9. Plaintiffs argue that the FDA has already issued the definition of a dietary supplement, 

and the Court need only determine whether the ingredients in question constitute dietary 

supplements within the meaning of the statute. Id. at 24:17-20. Defendant contends that the 

Court should leave the question of statutory interpretation of these products principally to the 

FDA. See Supp. Br. at 6:11-17. The Court agrees with Defendant and declines Plaintiffs’ 

invitation. 

Plaintiffs rely on United States v. Undetermined Quantities of All Articles of Finished & 

In-Process Foods, 936 F.3d 1341, 1344 (11th Cir. 2019), to assert that courts do not need the 

FDA’s expertise to determine whether certain ingredients constitute dietary supplements under 

DSHEA. See Opp’n at 24:23-27. The Eleventh Circuit in Undetermined Quantities concluded 

that Defendant’s DMAA constituted a dietary supplement under DSHEA. Id. at 1344. 

Specifically, the court determined that DMAA was neither a “herb or other botanical” nor a 

“constituent” of an herb or other botanical to qualify as a dietary supplement under DHSEA. Id. 

at 1351. See also 21 U.S.C. § 321(ff)(1) (“The term ‘dietary supplement’ means a product . . . 

intended to supplement the diet that . . . contains one or more of the following dietary 

ingredients: an herb or other botanical . . . or constituent [of an herb or other botanical]”). 

Although the Court recognizes the Eleventh Circuit’s interpretation, it declines the 

request to conduct an analysis here. Whether DMAA, DMHA, and methylsynephrine constitute 

dietary supplements under DSHEA requires the “determination of technical and scientific 

questions” best left to the FDA. Biotics, 710 F.2d at 1377 (quoting Weinberger v. Bentex 

Pharmaceuticals, Inc., 412 U.S. 645, 654 (1973)). Furthermore, if this Court proceeds with its 

analysis, it is possible that its interpretation may differ from that of other courts. The Northern 

District of California coming to a different interpretation of whether DMHA constitutes a 

dietary supplement under DSHEA than the Central District of California, for example, would 

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create problems in “uniformity of administration.” Gen. Dynamics Corp., 828 F.2d at 1362. 

Various courts reaching different conclusions as to whether DMHA or methylsynephrine 

constitute dietary supplements would create the exact conflict that the Ninth Circuit 

acknowledged in Syntek and General Dynamics. 

Accordingly, the Court finds that the determination of DMAA, DMHA, and 

methylsynephrine as dietary supplements under DSHEA requires both the expertise of the FDA 

and uniformity in administration. 

IV. Disposition

For the reasons set forth above, the Court GRANTS WITHOUT PREJUDICE

Defendant’s Motion to Dismiss. 

 DATED: 

DAVID O. CARTER 

UNITED STATES DISTRICT JUDGE 

July 29, 2020

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