MEMORANDUM OPINION
Plaintiffs, the Holistic Candlers and Consumer Association and other individual manufacturers, consumers, and private associations (“plaintiffs”), bring this action against the U.S. Food and Drug Administration (“FDA” or the “agency”) and other agencies and officials in the United States government (collectively, “defendants”) alleging violations of plaintiffs’ First, Ninth, Tenth, and Fourteenth Amendment rights; seeking injunctive relief staying the FDA’s determination that plaintiffs’ holistic candles are unapproved medical devices under 21 U.S.C. § 321; and seeking declaratory relief voiding the FDA’s determination. Before this Court is defendants’ Motion to Dismiss [Dkt. # 7]. Upon consideration of the parties’ pleadings, relevant law, and the entire record, the defendants’ motion is GRANTED.
BACKGROUND
Plaintiffs are a collection of individuals, organizations, and associations who manufacture, distribute, consume, and advocate for the use of “holistic candles,” commonly referred to as “ear candles.” Pis.’ Compl. (“Compl.”), Apr. 12, 2010, ¶¶ 2-3, 15 [Dkt. # 1], Made of fabric soaked in beeswax or paraffin, ear candles are hollow cones placed into the ear and set on fire with an open flame. Defs.’ Mot. to Dismiss, June 10, 2010, at 1 [Dkt. # 7], Certain of the plaintiff-manufacturers historically1 marketed ear candles for uses such as “[h]elping people with ... sinus congestion, colds, the flu, sore throats, earaches, ear infections, sinus infections, lymphatic congestion, swollen glands,” (Defs.’ Mot. to Dismiss, Ex. B at 3 [Dkt. # 7-2]); obtaining relief from Meniere’s Disease, tinnitus, sleep disorders, and vision disorders (id. at 5); and extracting wax and infectious fluid from a child’s ear (id. at 7).
On February 17, 2010, the FDA issued Warning Letters to fifteen manufacturers and distributors of ear candles (Compl. ¶ 17; Defs.’ Mot. to Dismiss at 1) — including five named plaintiffs2 in this case (Defs.’ Mot. to Dismiss at 15) — objecting to certain marketing claims the manufacturers made about ear candles.3 In the let*159ters, the FDA explained that ear candles are considered “devices” under the Federal Food, Drug, and Cosmetic Act (“the FDCA” or “the Act”), and thus regulated by the FDA, because they are
“an instrument, apparatus, [or] implement ... which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, ... or intended to affect the structure or any function of the body of man.”
21 U.S.C. § 321(h)(2), (3).
Further, the FDA advised the plaintiff-manufacturers that they had violated the FDCA by labeling and marketing devices (ear candles) without the agency’s clearance or approval. Defs.’ Mot. to Dismiss at l.4 The agency referred the manufacturers to the FDA website for information about how to obtain approval and clearance for devices and noted that the “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Id. at l.5 The FDA requested that the manufacturers “cease marketing and distribution of ear candles ... the same as or similar to those described [in the letter]” and stated that the failure to correct FDCA violations “may result in regulatory action.” Defs.’ Mot. to Dismiss, Ex. B at 6. Finally, the FDA asked recipients of the Warning Letters to submit, within fifteen business days, a written response outlining each recipient’s intent to comply with the FDA’s request. Defs.’ Mot. to Dismiss at 19 n. 20; Ex. B at 3. Some of the fifteen letter recipients— including Harmony Cone, a named plaintiff in this case — complied with the FDA’s request for a written response; others agreed to voluntarily cease marketing ear cones or to remove health claims from promotional materials. Defs.’ Mot. to Dismiss at 11. But no company presented the FDA with proposed labeling disclaimers or disclosures for the agency’s evaluation. Id.
Notwithstanding their prior marketing and representations, plaintiffs now claim that ear cones “are not medical devices,” Compl. ¶¶ 18-19, 29. Instead, they contend, ear candles are generic products used for “holistic ... relaxation [and] comfort” and are thus exempt from FDA regulation. Id. ¶¶ 3, 19-23. Alleging that the FDA’s issuance of Warning Letters constituted final agency action (Pis.’ Opp’n at 5) and that the agency has “effectively outlawed]” ear candles (Comply 3), plaintiffs filed this suit against the FDA on April 9, 2010: less than two months after the FDA issued the February 17 Warning Letters. See Defs.’ Mot. to Dismiss at 12.
To date, the FDA has not initiated enforcement action against any named plaintiff. Id. at 11.
ANALYSIS
I. Standard of Review
Defendants move to dismiss this action pursuant to Fed.R.Civ.P. 12(b)(1). A Rule *16012(b)(1) motion shall be granted if a plaintiff fails to establish subject-matter jurisdiction. A plaintiff -bears the burden of proving subject-matter jurisdiction, and the standing required to invoke it. See U.S. Ecology, Inc. v. U.S. Dep’t of Interior, 231 F.3d 20, 24 (D.C.Cir.2000). In addition, a plaintiffs claim must also be ripe. Importantly, a “claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.” Texas v. United States, 523 U.S. 296, 300, 118 S.Ct. 1257, 140 L.Ed.2d 406 (1998) (citations omitted).
Defendants also move to dismiss plaintiffs’ complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief may be granted. To survive a Rule 12(b)(6) motion to dismiss, a plaintiff must support its complaint with “any set of facts consistent with the allegations” such that the complaint “possess[es] enough heft to show that the pleader is entitled to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557, 563, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citations omitted).
Unfortunately for plaintiffs, even taking as true all allegations in the complaint, see Holy Land Found. for Relief & Dev. v. Ashcroft, 333 F.3d 156, 165 (D.C.Cir.2003), each of plaintiffs’ claims must, for the following reasons, be dismissed.
II. Rule 12(b)(1) Motion
A. Plaintiffs Lack Standing Because They Cannot Demonstrate Actual Injury.
First, plaintiffs’ claims must be dismissed for lack of subject-matter jurisdiction because plaintiffs cannot, and do not, demonstrate the actual injury required to establish standing. A litigant bears the burden of showing that is has “suffered, or be[en] threatened with, an actual injury traceable to the defendant and likely to be redressed by a favorable judicial decision.” Lewis v. Cont'l Bank Corp., 494 U.S. 472, 477, 110 S.Ct. 1249, 108 L.Ed.2d 400 (1990); see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). But plaintiffs do not “allege that [they] ha[ve] been or will in fact be perceptibly harmed by, the challenged agency action, not that [they] .can imagine circumstances in which [they] could be affected by the agency’s action.” United States v. Students Challenging Reg. Agency Procs. (SCRAP), 412 U.S. 669, 688-89, 93 S.Ct. 2405, 37 L.Ed.2d 254 (1973) (emphasis added). In fact, despite plaintiffs’ allegations of “imminent peril of risk of health or life, loss of liberty, property, [and] livelihood or licensure,” Compl. ¶ 14, plaintiffs’ case is one of imagined injury. Indeed, the FDA’s only official action in this case occurred in February 2010, when it issued Warning Letters to some named plaintiffs.6 Defs.’ Mot. to Dismiss at 11, 15. That the FDA has taken no additional official action- — enforcement or otherwise — undercuts plaintiffs’ assertion that they have suffered real (much less imminent) harm. The mere allegation that the FDA “effectively outlawed]” ear candles, Compl. ¶ 3, or that plaintiffs are “at imminent risk of loss of income,” id. ¶ 8, does not suffice to prove actual injury where the FDA has initiated no enforcement action, seized no personal property, imposed no *161civil fíne, and banned no device.7 See Estee Lauder, Inc. v. FDA, 727 F.Supp. 1, 4 (D.D.C.1989); see also Regen. Scis., Inc. v. FDA, No. 09-cv-00411, 2010 WL 1258010, at *8 (D.Colo. March 26, 2010) (“The fact remains that [plaintiff] has not shown any specific concrete action taken by the FDA that has harmed it or any specific losses it has suffered as a result of FDA action.”). Accordingly, plaintiffs do not have standing to bring their declaratory and injunctive claims against the FDA.8
B. Plaintiffs Lack SubjecL-Matter Jurisdiction Because There Has Been No Final Agency Action and Plaintiffs’ Claims Are Not Ripe.
Plaintiffs also lack subject-matter jurisdiction on a separate but related ground: ripeness. A claim is not ripe for review if “judicial intervention would inappropriately interfere with further administrative action,” Ohio Forestry Ass’n v. Sierra Club, 523 U.S. 726, 733, 118 S.Ct. 1665, 140 L.Ed.2d 921 (1998), or if “it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all.” Texas, 523 U.S. at 300, 118 S.Ct. 1257 (internal quotations omitted). To determine whether a litigant’s claims are ripe, courts look to two factors: “the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.” Abbott Labs. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) (abrogated on other grounds). When evaluating the first factor, fitness, our Circuit makes three additional inquiries: “whether the issue raised is a purely legal one; whether immediate judicial review is calculated to avoid multiplicity of litigation; and whether the agency position is final and not likely to be reconsidered.” Estee Lauder, Inc. v. FDA, 727 F.Supp. 1, 4 (D.D.C.1989) (citing Indep. Bankers Ass’n of Am. v. Smith, 534 F.2d 921, 927-29 (D.C.Cir.), cert. denied, 429 U.S. 862, 97 S.Ct. 166, 50 L.Ed.2d 141 (1976)). The “hardship” inquiry asks “whether the agency’s position has a direct and immediate ... effect on the day-to-day business[ ] of the complaining parties.” Estee Lauder, 727 F.Supp. at 4 (internal citations and quotations omitted).
Here, plaintiffs meet none of the criterion for ripeness. Of the factors relevant to the ripeness inquiry, both parties agree that one is the lynchpin: whether the FDA’s Warning Letters constitute final agency action. Here, they did not. How so?
Under the Administrative Procedure Act (“APA”), agency action is subject to judicial review when it is final and “there is no other adequate remedy in a court.” 5 U.S.C. § 704. “A preliminary, procedural, or intermediate agency action or ruling not *162directly reviewable is subject to review on the review of the final agency action.” Id. Plaintiffs argue that FDA Warning Letters generally — and the letters issued to certain plaintiffs in this case specifically— constitute final agency action. Compl. ¶ 10; Pis.’ Opp’n at 11-12, 22-27. But the text of the Warning Letters plainly contradicts plaintiffs’ claims of finality.9 To wit, the letters indicate that further evaluation is required (see Defs.’ Mot. to Dismiss, Ex. B at 3) (“The FDA will evaluate the information you submit and decide whether your product may be legally marketed.”), and that the FDA’s instructions are not final demands, but rather intermediate requests for voluntary compliance. See id. (“FDA requests that Harmony Cone immediately cease marketing, promoting and distributing ... ear candles.... Failure to promptly correct these deviations may result in regulatory action being initiated.”) (emphasis added). Moreover, FDA policy is clear: Warning Letters are informal, advisory, and not intended to serve as final agency action. FDA, Regulatory Procedures Manual § 4-1-1 (Mar. 2010) (“A Warning Letter is informal and advisory.... FDA does not consider Warning Letters to be final agency action on which it can be sued.”) (emphasis added).
Most importantly, the FDA’s view that “[a Warning Letter] communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action,” id., also comports with the law of our Circuit. See, e.g., Am. Fed’n of Gov’t Emps. v. O’Connor, 747 F.2d 748, 752-53 (D.C.Cir.1984) (agency’s informal advisory opinion unripe for judicial review because it “binds neither the public nor any agency or officer of the government”). Indeed, the analysis by another Judge on our Court in Estee Lauder is particularly instructive. 727 F.Supp. at 1. There, a cosmetic manufacturer sued the FDA based on a “regulatory letter” sent by an agency employee which outlined objections to the manufacturer’s labeling of a skin cream and classified the cream as a drug under the FDCA. Id. at 2-3. Engaging in a six-factor analysis of finality, the court concluded that the FDA regulatory letter was “by its very nature informal and advisory” and determined that the letter did not constitute final agency action subject to judicial review. Id. at 4-5.10 Simply put, these plaintiffs — just like the plaintiffs in Estee Lauder — fail to demonstrate that their claims are fit for review.11 Because plaintiffs’ claims are not ripe, this Court does not have subject-matter jurisdiction to review them.
C. This Court Has No Jurisdiction to Review Plaintiffs’ PreEnforcement Challenge.
In addition, plaintiffs’ efforts to obtain injunctive relief (a stay of the FDA’s determination that ear candles are medical *163devices) and declaratory relief (judgment that plaintiffs’ rights to manufacture ear candles are not limited), Compl. ¶¶ 42, 48, is nothing more than a pre-enforcement challenge foreclosed by Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594, 600, 70 S.Ct. 870, 94 L.Ed. 1088 (1950) (district court lacked jurisdiction to review the FDA’s pre-seizure determination of probable cause because “[j]udicial review of this preliminary phase of the administrative procedure does not fit the statutory scheme nor serve the policy of the [FDCA]”). See also Abbott Labs., 387 U.S. at 148, 87 S.Ct. 1507 (reaffirming the Ewing court’s rejection of “an unheard-of form of relief which, if allowed, would have permitted inferences in the early stages of an administrative determination as to specific facts, and would have prevented the regular operation of the seizure procedures established by the [FDCA]”). Here, as in Ewing, plaintiffs ask this Court for relief which, if granted, would preempt future FDA enforcement action such as injunctions, civil penalties, or seizures under the FDCA. See 21 U.S.C. §§ 332-34. The determination of FDCA violations is, of course, a factual one that the FDA must conduct on a plaintiff-by-plaintiff basis, at a relevant time and in light of each plaintiffs unique products and labeling. Unless and until the FDA has completed such an inquiry and taken legal action, this Court does not have jurisdiction over plaintiffs’ claims and may not review requests for injunctive or declaratory relief preventing the FDA from bringing enforcement actions against plaintiffs.
III. Rule 12(b)(6) Motion
Even taking as true all allegations in the complaint, see Holy Land Found. for Relief & Dev., 333 F.3d at 165, plaintiffs’ remaining claims fail as a matter of law because they have not exhausted their administrative remedies (here, the requirement of a “citizen petition”): a fact that plaintiffs admit. Compl. ¶ 17 (“The FDA determination was made without the prior petition of Citizens.”). Indeed, final agency action is required for judicial review under the APA. 5 U.S.C. § 704. But an agency action is “final for the purposes of [the APA]” only after a plaintiff “has exhausted all administrative remedies expressly prescribed by statute or agency rule.” Darby v. Cisneros, 509 U.S. 137, 146, 113 S.Ct. 2539, 125 L.Ed.2d 113 (1993). In this case, FDA regulations plainly state that “before any legal action is filed,” a party’s claim seeking action or inaction from the agency “must first be the subject of a final administrative decision based on a [‘citizen’] petition submitted under § 10.25(a).” 21 C.F.R. § 10.45(b). Unfortunately, plaintiffs have not initiated the administrative-review process, let alone exhausted their administrative remedies.12 By failing to challenge the Warning Letters through a citizen petition, see 21 C.F.R. § 10.25, plaintiffs preclude, as a matter of law, judicial review of their claims.13 See Ass’n of Am. Physicians & Surgeons, Inc. v. FDA, 539 F.Supp.2d 4, *16421-22 (D.D.C.2008) (dismissing under Rule 12(b)(6) plaintiffs’ claims against the FDA for failure to exhaust administrative remedies including a citizen petition), aff’d, 358 Fed.Appx. 179 (D.C.Cir.2009), cert. denied, — U.S. —, 131 S.Ct. 1062, 178 L.Ed.2d 863 (2011).
Finally, even if plaintiffs had standing to sue the FDA — which they do not — and even if plaintiffs’ claims were ripe and their administrative remedies exhausted— which they are not — the remaining statutory and constitutional claims would still fail as a matter of law. Some of these claims fail because they assert conclusory allegations without pleading the elements necessary to prevail as a matter of law.14 Others claims are insufficient as a matter of law.15 Still others fail because no private right of action exists for the alleged violations.16 In sum, plaintiffs’ remaining claims are foreclosed by plaintiffs’ failure to exhaust administrative remedies, or they fail simply as a matter of law.
CONCLUSION
For all of the foregoing reasons, the Court GRANTS the defendants’ Motion to Dismiss [Dkt. #7] and DISMISSES the action without prejudice. An order consistent with this decision accompanies this Opinion.
ORDER
For the reasons set forth above, it is this _day of March, 2011 hereby
*165ORDERED that Defendants’ Motion to Dismiss [Dkt. # 7] is GRANTED, and it is further ORDERED that the above-captioned case be dismissed without prejudice.
SO ORDERED.