AMERICAN INTERNATIONAL INDUSTRIES v. Matthew Urbach et al., Real Parties in Interest. (1999)

Defendants American International Industries (AII) and Combe Incorporated (Combe) (collectively, defendants) petition for a writ of mandate directing respondent superior court to vacate its order denying their motion for judgment on the pleadings and to enter an order granting the motion.

The issue presented is whether the instant action by plaintiffs and real parties in interest Matthew Urbach, Fred Dorsett, Todd Richardson, Ronald Spitzer, Bill Ladd and Bill Brinker (collectively, the Urbach plaintiffs) is barred on the grounds of res judicata and/or by federal law.

We conclude certain causes of actions are barred by res judicata and others by the Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.).   The only cause of action which is not barred is the products liability claim.   Therefore, the petition is granted in part and denied in part.

FACTUAL AND PROCEDURAL BACKGROUND

1.  The prior action.

The Center for Environmental Health (CEH) is a nonprofit corporation aimed at protecting the environment, improving human health and supporting environmentally sound practices.   Combe and AII manufacture and distribute Grecian Formula and other hair coloring products in California, which products contain lead acetate.   Pursuant to Health and Safety Code section 25249.5 et seq., the Safe Drinking Water and Toxic Enforcement Act of 1986 (Toxic Enforcement Act), commonly known as Proposition 65, lead, lead compounds and lead acetate have been formally listed by the State of California as chemicals known to cause cancer, birth defects or other reproductive harm.¹

On August 9, 1996, CEH served Combe, AII and the California Attorney General with a document entitled “Notice of Violation of Proposition 65,” which gave notice that Combe and AII allegedly were in violation of the Toxic Enforcement Act for failing to warn purchasers that certain products they sell in California expose users to toxic chemicals listed under the Toxic Enforcement Act.²

On February 7, 1997, CEH filed suit against Combe and AII in the San Francisco Superior Court, alleging (1) violation of the Toxic Enforcement Act;  and (2) violation of the Unfair Competition Act (Bus. & Prof.Code, § 17200 et seq.) on behalf of the general public, including individuals in California, who allegedly were exposed to lead acetate.³  The gravamen of the suit was defendants' alleged failure to disclose that their products contained lead acetate.

With the involvement of the Attorney General, the action was resolved by a settlement agreement and stipulated judgment filed January 7, 1998.   The settling parties were CEH, Combe and AII.

Although the suit by CEH was premised on a failure to warn theory, the remedy provided in the settlement was a reformulation of the products.   In the settlement agreement, Combe and AII undertook to “pursue in good faith reformulation of the Products to reduce the amount of lead acetate ․ by 50%․”  After the “Compliance Date,” AII and Combe would manufacture, distribute or sell only the reformulated products.   The judgment also provided it was subject to vacation if defendants were unable to achieve the reformulated level of lead acetate.⁴

Combe and AII also agreed to issue at least $70,000 in coupons to California consumers and to pay $69,000 in restitution to CEH, which monies were to be allocated to three other CEH projects.   Those projects were aimed at eliminating the abuse of toluene by inner city youth, reducing toxic exposures from a waste incineration plant in Oakland, and identifying safer alternatives to the use of lead in the home and workplace.

In addition, Combe and AII agreed to pay a civil penalty of $22,500 to CEH and to pay CEH $173,500 as reimbursement for its attorney fees, costs and other expenses.

With respect to the effect of the judgment, the agreement recited:  “Effect of Entry of Judgment.   Entry of judgment by the court pursuant to this Agreement shall, inter alia:  [¶] (a) constitute a full and final adjudication of all claims against Combe and AII, including but not limited to any claims based upon alleged violations of the Toxic Enforcement Act, Business and Professions Code section 17200 et seq., or any other statute, provision of common law or any theory or issue which arise from the alleged failure to provide warning of exposure to lead and lead compounds, including lead acetate, from use of the Products offered for sale in California;  and [¶] (b) bar any and all other persons from prosecuting against any Releasee any claim, including but not limited to any claim based upon alleged violations of the Toxic Enforcement Act, Business and Professions Code section 17200 et seq., or any other statute, provision of common law or any theory or issue which arise from the alleged failure to provide clear and reasonable warning of exposure to lead and lead compounds, including lead acetate, from use of the Products offered for sale in California.”

The Attorney General, who participated in the settlement, also affirmed that this resolution was in the public interest.   A condition of the settlement agreement was that it be signed by a representative of the Attorney General and it stated:  “The signature of the representative of the Office of the Attorney General evidences the view of that office that no further action is warranted concerning the violations alleged against Combe and AII, and that this Agreement is in the best interest of the general public.”   The Attorney General signed off on the agreement.⁵

The settlement agreement contained a nondisclosure provision, paragraph 21, which states:  “Publication of Agreement.   No party or its attorney may make public in any way the existence or the terms of this Agreement prior to the time the Court approves it and judgment is entered.   The parties agree that neither of them nor their representatives shall issue any press release or make any other disclosure with intent that such disclosure will directly or indirectly result in notifying the media about this Agreement or any of its provisions prior to the Compliance Date as defined in paragraph 13.” ⁶  Thus, the nondisclosure provision was aimed at affording defendants the opportunity to reformulate their products before the general public would learn of the controversy surrounding the lead content of the products.⁷

2. The instant action.

On July 7, 1997, while the prior action against AII and Combe was still pending in the San Francisco Superior Court, the Urbach plaintiffs, on their own behalf and on behalf of all others similarly situated, filed the instant class action complaint in Los Angeles Superior Court against AII and Combe, arising out of the marketing and sale of hair coloring products to consumers without warning of the potential dangers associated with lead acetate, a color additive.   The complaint alleged:  (1) violation of Civil Code section 1770, the Consumers Legal Remedies Act;  (2) fraud by concealment;  (3) false and misleading advertising (Bus. & Prof.Code, § 17500);  (4) violation of the Toxic Enforcement Act;  and (5) violation of Business and Professions Code section 17200 et seq.

The complaint also sought an order certifying the class and appointing the plaintiffs and their counsel to represent the class.⁸

An amended complaint followed, adding a sixth cause of action for products liability based on failure to warn.   In that cause of action, plaintiffs sought compensatory damages to cover the cost of cleaning their homes to eliminate the lead products' hazard, and to pay for the medical testing of children exposed to the products.   Plaintiffs expressly excluded from this cause of action any and all claims for personal injury resulting from hand-to-surface transfer and ingestion of the lead contained in the products.

Combe and AII filed answers setting forth numerous affirmative defenses, including res judicata and federal preemption.

On February 2, 1998, shortly after entry of judgment in the San Francisco action, Combe and AII brought a motion for judgment on the pleadings in the Los Angeles action.   They contended the complaint should be dismissed in its entirety because the judgment in the CEH action had res judicata effect and the causes of action for false advertising, fraud by concealment and violation of the Consumers Legal Remedies Act were barred by federal law.

In opposition, the Urbach plaintiffs argued defendants were seeking to circumvent the protections afforded members of a class action by imposing the terms of a non-class settlement under the misapplication of the doctrine of res judicata.   Plaintiffs contended:  “If the court were to buy into the position advanced by defendants, every class action could be subverted by a non-class settlement under [section] 17200 of the Business and Professions Code. Gone would be the court's supervision over the adequacy of the representation;  the fairness of the terms of the settlement and its collusive or non-collusive nature;  and the right of class members to receive notice of the terms of the settlement and to ‘opt out’ if they felt the terms were not to their advantage.”

On February 17, 1998, the trial court denied defendants' motion for judgment on the pleadings.   It observed “defendants have not located a single case where a representative action by a watchdog agency has been held to have completely barred a subsequent class action.   The issue of res judicata effect in [Business and Professions Code] actions is unclear, but is probably limited to barring other representative actions, and representative causes of action.   [¶] As important as it is that res judicata not be undercut, it is even more important that individual citizens, who have personal claims, not be deprived of due process.”  (Italics deleted.)

Defendants filed this petition for writ of mandate, seeking to overturn the trial court's order denying their motion for judgment on the pleadings.

This court issued an alternative writ of mandate.

CONTENTIONS

Defendants contend the Urbach plaintiffs are barred by res judicata from maintaining this lawsuit and the trial court erred in not dismissing the action on that basis.   Defendants also contend there is no private right of action for violation of the FDCA and the Urbach plaintiffs' action is simply an attempt to plead around that prohibition.⁹

DISCUSSION

1. Standard of review.

 Because a motion for judgment on the pleadings is the functional equivalent of a general demurrer, the same rules apply.  (People v. $20,000 U.S. Currency (1991) 235 Cal.App.3d 682, 691, 286 Cal.Rptr. 746.)

 A demurrer serves to test the sufficiency of a pleading by raising questions of law.  (Buford v. State of California (1980) 104 Cal.App.3d 811, 818, 164 Cal.Rptr. 264.)   On review, we determine whether the complaint states facts sufficient to constitute a cause of action.  (Blank v. Kirwan (1985) 39 Cal.3d 311, 318, 216 Cal.Rptr. 718, 703 P.2d 58.)   The allegations are regarded as true and are liberally construed with a view to attaining substantial justice.  (Shaeffer v. State of California (1970) 3 Cal.App.3d 348, 354, 83 Cal.Rptr. 347;  King v. Central Bank (1977) 18 Cal.3d 840, 843, 135 Cal.Rptr. 771, 558 P.2d 857.)

 In addition, other relevant matters which are properly the subject of judicial notice, such as the stipulated judgment in the San Francisco action, may be treated as having been pled.  (Marina Tenants Assn. v. Deauville Marina Development Co. (1986) 181 Cal.App.3d 122, 128, 226 Cal.Rptr. 321.)

2. Action partially barred by res judicata.

a. General principles.

 “The doctrine of res judicata precludes parties or their privies from relitigating a cause of action that has been finally determined by a court of competent jurisdiction.   Any issue necessarily decided in such litigation is conclusively determined as to the parties or their privies if it is involved in a subsequent lawsuit on a different cause of action.   [Citations.]  The rule is based upon the sound public policy of limiting litigation by preventing a party who has had one fair trial on an issue from again drawing it into controversy.  [Citations.]  The doctrine also serves to protect persons from being twice vexed for the same cause.   [Citation.]  It must, however, conform to the mandate of due process of law that no person be deprived of personal or property rights by a judgment without notice and an opportunity to be heard.  [Citation.]”  (Bernhard v. Bank of America (1942) 19 Cal.2d 807, 810-811, 122 P.2d 892.)

 Res judicata applies when (1) the issues decided in the prior proceeding are identical to those in the second litigation;  (2) there was a final judgment on the merits in the prior action;  and (3) the party against whom the doctrine is asserted was a party or in privity with a party to the prior adjudication.  (Citizens for Open Access etc. Tide, Inc. v. Seadrift Assn. (1998) 60 Cal.App.4th 1053, 1065, 71 Cal.Rptr.2d 77.) ¹⁰

b. The San Francisco stipulated judgment was a final decision on the merits.

 For res judicata purposes, a judgment entered by stipulation, is as conclusive a bar as a judgment rendered after trial, at least when the parties manifest an intent to be collaterally bound by its terms.  (California State Auto. Assn. Inter-Ins. Bureau v. Superior Court (1990) 50 Cal.3d 658, 664, 268 Cal.Rptr. 284, 788 P.2d 1156;  Citizens for Open Access etc.   Tide, Inc., supra, 60 Cal.App.4th at p. 1065, 71 Cal.Rptr.2d 77;  Johnson v. American Airlines, Inc. (1984) 157 Cal.App.3d 427, 431, 203 Cal.Rptr. 638;  see generally, 7 Witkin, Cal. Procedure (4th ed.   1997) Judgment, § 315(c), p. 866.)

The provision in the settlement agreement captioned “Effect of Entry of Judgment,” quoted earlier, manifests a clear intent by the parties to be bound by the judgment as “a full and final adjudication of all claims against Combe and AII, ․” Therefore, the stipulated judgment in the San Francisco action amounted to a final judgment entitled to res judicata effect, provided the other elements of res judicata are satisfied.

c. Privity between Urbach plaintiffs and the CEH and Attorney General.

Although the Urbach plaintiffs are not parties to the stipulated judgment, they may be bound by its terms if they are in privity with CEH and the Attorney General, which entities were parties to the settlement in the San Francisco action.  (Citizens for Open Access etc.   Tide, Inc., supra, 60 Cal.App.4th at p. 1069, 71 Cal.Rptr.2d 77.)

 “The concept of privity for the purposes of res judicata or collateral estoppel refers ‘to a mutual or successive relationship to the same rights of property, or to such an identification in interest of one person with another as to represent the same legal rights [citations] and, more recently, to a relationship between the party to be estopped and the unsuccessful party in the prior litigation which is “sufficiently close” so as to justify application of the doctrine of collateral estoppel.  [Citations.]’  [Citations.]  ‘ “This requirement of identity of parties or privity is a requirement of due process of law.”  [Citation.]  “Due process requires that the nonparty have had an identity or community of interest with, and adequate representation by, the ․ party in the first action.  [Citations.]  The circumstances must also have been such that the nonparty should reasonably have expected to be bound by the prior adjudication․”  ’ [Citations.]”   (Citizens for Open Access etc.   Tide, Inc., supra, 60 Cal.App.4th at pp. 1069-1070, 71 Cal.Rptr.2d 77.)

 As our Supreme Court has recognized, “[p]rivity is a concept not readily susceptible of uniform definition” (Clemmer v. Hartford Insurance Co. (1978) 22 Cal.3d 865, 875, 151 Cal.Rptr. 285, 587 P.2d 1098), and determination of whether it exists is not a cut-and-dried exercise.   In the final analysis, the determination of privity depends upon the fairness of binding a litigant with the result obtained in earlier proceedings in which it did not participate.  (Citizens for Open Access etc.   Tide, Inc., supra, 60 Cal.App.4th at p. 1070, 71 Cal.Rptr.2d 77.)

To illustrate, in Gates v. Superior Court (1986) 178 Cal.App.3d 301, 223 Cal.Rptr. 678, an issue presented was whether entry of a stipulated consent decree and judgment in a taxpayer suit brought in the public interest, challenging certain practices of the Los Angeles Police Department, was res judicata so as to bar a subsequent taxpayer suit by other plaintiffs, challenging the same practices.  (Id., at pp. 305-308, 223 Cal.Rptr. 678.)   Gates noted the two suits were “brought by taxpayers suing in a representative capacity” and held “[j]udgments in representative taxpayer actions are binding on all other taxpayers even though the named taxpayer plaintiff in the second suit was not the same taxpayer who brought the original case.”  (Id., at p. 307, 223 Cal.Rptr. 678.)

 The same analysis applies here.   Privity exists between the Urbach plaintiffs and CEH. That entity had statutory authority to bring the prior action on behalf of the general public in a representative capacity.   An action to enforce the Toxic Enforcement Act “may be brought by any person in the public interest,” provided certain conditions are met.  (Health & Saf.Code, § 25249.7, subd. (d).)  Similarly, an action under the Unfair Competition Act (Bus. & Prof.Code, § 17200 et seq.) may be prosecuted “by any person acting for the interests of ․ the general public.”  (Bus. & Prof.Code, § 17204.)  “ ‘ “[W]hen a party acts in a representative capacity, and as such is lawfully authorized to litigate the questions at issue for those whom he represents, they as well as he are bound by the judgment.   [Citation.]”  [Citations.]’  ” (Citizens for Open Access etc. Tide, Inc., supra, 60 Cal.App.4th at p. 1072, 71 Cal.Rptr.2d 77.)   Therefore, the Urbach plaintiffs, as members of the public, are in privity with CEH, which brought the prior action under the Toxic Enforcement Act and the Unfair Competition Act in a representative capacity on behalf of the general public.

 Additionally, although the Attorney General did not bring the San Francisco action, the Attorney General was a participant and signatory to the settlement agreement therein.   The settlement agreement recites:  “The signature of the representative of the office of the Attorney General evidences the view of that office that no further action is warranted concerning the violations alleged against Combe and AII, and that this Agreement is in the best interest of the general public.”   The Attorney General is the chief law officer of the state (Cal. Const., art.   V, § 13) and represents the interests of the people in matters of public concern.  (Citizens for Open Access etc. Tide, Inc., supra, 60 Cal.App.4th at p. 1071, 71 Cal.Rptr.2d 77.)   The Attorney General's participation in this manner resulted in a settlement which considered and protected the interests of all of the people of California.   Therefore, the Urbach plaintiffs are also in privity with the Attorney General, who approved the settlement agreement as being in the public interest.¹¹

In sum, to the extent the Urbach plaintiffs are seeking injunctive relief and restitution based on defendants' failure to disclose the possible hazards in their lead-containing products, they are in privity with the CEH and the Attorney General, whose prior lawsuit resolved such claims brought under the Toxic Enforcement Act and the Unfair Competition Act.

d. Identity of issues element;  same “primary right” bars certain causes of action.

We turn to an examination of the identity of issues requirement.

 Unless the issue or cause of action in the two actions is identical, the first judgment does not stand as a bar to the second suit.   (Citizens for Open Access etc. Tide, Inc., supra, 60 Cal.App.4th at p. 1067, 71 Cal.Rptr.2d 77.)   The question of whether a cause of action is identical for purposes of res judicata depends not on the legal theory or label used, but on the “primary right” sought to be protected in the two actions.  (Ibid.) The invasion of one primary right gives rise to a single cause of action.  (Slater v. Blackwood (1975) 15 Cal.3d 791, 795, 126 Cal.Rptr. 225, 543 P.2d 593.)   The “ ‘cause of action’ is based upon the harm suffered, as opposed to the particular theory asserted by the litigant.  [Citation.]”  (Ibid., italics added.)   In short, the res judicata effect extends only to the same primary right.  (Citizens for Open Access etc. Tide, Inc., supra, at p. 1067, 71 Cal.Rptr.2d 77.)

Therefore, the two actions must be compared, looking at the rights which are sought to be vindicated and the harm for which redress is claimed.   (Citizens for Open Access etc. Tide, Inc., supra, 60 Cal.App.4th at p. 1067, 71 Cal.Rptr.2d 77.)

 The record before us discloses the Urbach plaintiffs charge defendants with failing to warn of lead acetate in their products in violation of Business and Professions Code section 17200 and the Toxic Enforcement Act. These issues are identical to those resolved by the San Francisco stipulated judgment.   As indicated, the earlier action, which CEH brought on behalf of the public in a representative capacity, alleged violations of Business and Professions Code section 17200 and the Toxic Enforcement Act, predicated on defendants' failure to disclose that their products contained lead acetate.   Therefore, the instant claims under Business and Professions Code section 17200 and the Toxic Enforcement Act are barred by res judicata.

 Also barred by res judicata is the instant claim for false advertising under Business and Professions Code section 17500.   The false advertising claim by the Urbach plaintiffs alleges defendants advertised the sale of their lead-containing products to the public without disclosing the possible dangers posed thereby.   While CEH did not allege such a claim in the prior action, it could have done so.   When an issue has been litigated, “all inquiry respecting the same matter is foreclosed, not only as to matters heard but also to matters that could have been heard in support of or in opposition thereto.”  (Gates, supra, 178 Cal.App.3d at p. 308, 223 Cal.Rptr. 678, italics added.)   The applicable statutory scheme authorizes private individuals to seek injunctive relief.  (Bus. & Prof.Code, § 17535;  Chern v. Bank of America (1976) 15 Cal.3d 866, 875, 127 Cal.Rptr. 110, 544 P.2d 1310.)   Because CEH could have brought a false advertising claim under Business and Professions Code section 17500 based on the nondisclosure of lead acetate (Bus. & Prof.Code, § 17535), in conjunction with its claims under Business and Professions Code section 17200 and the Toxic Enforcement Act, the Urbach plaintiffs are foreclosed from doing so herein.

e. Urbach plaintiffs' due process not violated by prior judgment binding them because res judicata elements are satisfied.

 As explained above, the Urbach plaintiffs' claims under Business and Professions Code sections 17200 and 17500, and under the Toxic Enforcement Act, are barred by res judicata because all the elements are met.   The San Francisco stipulated judgment was a final judgment on the merits.   The Urbach plaintiffs are in privity with CEH and the Attorney General, who represented their interests in the prior action.   Further, because the instant Business and Professions Code section 17200 and Toxic Enforcement Act claims already were litigated in the prior action, and the instant Business and Professions Code section 17500 claim could have been litigated in the prior action, as to these claims there is an identity of issues between the two actions.

 For purposes of res judicata, “ ‘ “[d]ue process requires that the nonparty have had an identity or community of interest with, and adequate representation by, the ․ party in the first action.  [Citations.]  The circumstances must also have been such that the nonparty should reasonably have expected to be bound by the prior adjudication․”  ’ [Citations.]”   (Citizens for Open Access etc. Tide, Inc., supra, 60 Cal.App.4th at p. 1070, 71 Cal.Rptr.2d 77.)   Here, CEH brought the prior action on behalf of the general public in a representative capacity.   Moreover, the Attorney General, who represents the interests of the people of this state in matters of public concern (id., at p. 1071, 71 Cal.Rptr.2d 77), approved the settlement as being in the public interest.   Consequently, we conclude the interests of the Urbach plaintiffs were amply protected in the prior action so as to satisfy due process concerns.

3. Three other causes of action not barred by res judicata.

 The Urbach plaintiffs' three other causes of action-violation of the Consumers Legal Remedies Act, fraud by concealment, and products liability-are not barred by res judicata because they were not, and could not have been, litigated by CEH.

Under the Consumer Legal Remedies Act (Civ.Code, § 1750 et seq.), any consumer who suffers damage as a result of an unlawful act or practice may bring an action to recover actual damages.  (Civ.Code, § 1780, subd. (a)(1).)   CEH was not a consumer of the subject products and it did not and could not litigate the damage claims of individual consumers under the Consumers Legal Remedies Act. Similarly, CEH did not and could not litigate the tort claims of the individual plaintiffs herein.   Their claims for damages for fraudulent concealment and products liability were beyond the scope of the San Francisco action and are not barred by the judgment therein.¹²

4. Impact of FDCA on the Urbach plaintiffs' claims.

 The remaining issue is the effect of the federal Food, Drug and Cosmetic Act on those claims which are not barred by res judicata-violation of Consumers Legal Remedies Act (Civ.Code, § 1750 et seq.), fraud by concealment, and products liability.¹³ ,¹⁴

a. Overview.

In 1980, the federal Food and Drug Administration (FDA) found “the color additive lead acetate to be safe for use in cosmetics that color the hair on the scalp.”  (45 Fed.Reg. 72112 at 72116.)   The FDA approved the use of lead acetate in hair dyes, subject to the labeling requirement “Wash thoroughly if the product comes into contact with the skin.”  (21 C.F.R. § 73.2396(d) (1998).) ¹⁵

In their complaint, the Urbach plaintiffs acknowledge the FDA's approval of lead acetate, but argue another FDA regulation requires additional warnings.   The Urbach plaintiffs contend a study by Dr. Howard W. Mielke and others has called into question the safety of hair dyes containing lead acetate, and therefore 21 Code of Federal Regulations section 740.10 applies.¹⁶  In light of this new scientific data, these plaintiffs contend defendants were required by 21 Code of Federal Regulations section 740.10(b) to give additional warnings on their products.

b. No private right of action under FDCA, directly or indirectly.

The FDCA provides in relevant part:  “(a) Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”  (21 U.S.C. § 337, subd. (a).)  Courts “have generally interpreted this provision to mean that no private right of action exists to redress alleged violations of the FDCA. [Citations.]”  (Summit Technology v. High-Line Medical Instruments (C.D.Cal.1996) 922 F.Supp. 299, 305.)   The “right to enforce the provisions of the FDCA lies exclusively within the federal government's domain, by way of either the FDA or the Department of Justice.   [Citations.]”  (Ibid.)

Attempts by private parties to litigate noncompliance with FDCA requirements have been rejected.   In Summit Technology, supra, 922 F.Supp. at page 306, a cause of action for false advertising was deemed an attempt to circumvent the FDCA's denial of a private right of action to enforce violations thereof.   Similarly, a cause of action for unfair competition (Bus. & Prof.Code, § 17200) was dismissed on the ground, inter alia, it was an attempt to state a private cause of action under the FDCA. (Summit Technology, supra, at p. 316.)

In the instant complaint, the Urbach plaintiffs improperly seek to enforce FDCA regulatory requirements by way of state law claims.   The complaint alleges:  “Defendants, and each of them, have violated 21 CFR Section 740.10” by failing to conduct new safety studies in light of new information concerning the health hazard posed by lead acetate.   According to the recent Mielke study, lead acetate presents a substantial threat to consumers and young children, and “this fact has been suppressed and/or concealed by Defendants.”   Further, Defendants “manufactured, distributed, marketed for sale, and/or sold, LEAD PRODUCT to the public, without disclosing ․ that:  LEAD PRODUCT contains lead acetate and that such color additive posed ․ an unreasonable risk of harm to anyone who might use it, including young children and infants who live in the same household where LEAD PRODUCT is used by household members․”

These allegations form the basis of the Urbach plaintiffs' claims alleging violation of the Consumers Legal Remedies Act and fraud by concealment.   Allowing these two causes of action to proceed would require the superior court to intrude into an area of federal regulation within the expertise of the Food and Drug Administration.   Only by evaluating the reliability of the Mielke study can it be ascertained whether the study triggers a duty under the FDCA for defendants to respond.  (21 C.F.R. § 740.10(b).)   The FDA has the statutory responsibility for interpreting the FDCA in the first instance.  (Summit Technology, supra, 922 F.Supp. at p. 306, fn. 4.) Further, the FDA is far better equipped than the superior court to evaluate the scientific evidence on lead acetate.

c. Exceptions for initiative measures and for product liability claims.

 Also pertinent here is the preemption provision of 21 United States Code section 379s, pertaining to labeling or packaging of cosmetics.   This section states in relevant part:  “(a) Except as provided in subsection (b), (d), or (e) of this section, no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this Act, ․ [¶] ․ [¶] (d) Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State. [¶] (e) This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.”   (Italics added.)

 Thus, the sixth cause of action alleging products liability is not barred by the FDCA. (21 U.S.C. § 379s, subd. (d).)  Likewise, a claim under the Toxic Enforcement Act, an initiative measure approved in 1986, is not barred by the FDCA (21 U.S.C. § 379s, subd. (e)), but as discussed, said claim is barred by res judicata.

However, as noted above, the Urbach plaintiffs' claims alleging violation of the Consumers Legal Remedies Act and fraud by concealment are barred on the ground they seek indirectly to enforce FDCA requirements.

DISPOSITION

The alternative writ having served its purpose is discharged.   Let a writ of mandate issue directing respondent superior court to vacate its order denying the motion for judgment on the pleadings as to the first five causes of action and to grant the motion as to those causes of actions.   Each party to bear respective costs in this proceeding.

FOOTNOTES

1.   Health and Safety Code section 25249.6, which requires warnings to individuals of exposure to chemicals known to cause cancer or reproductive toxicity, states:  “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, ․”

2.   Health and Safety Code section 25249.7, subdivision (d), states:  “Actions pursuant to this section may be brought by any person in the public interest if (1) the action is commenced more than sixty days after the person has given notice of the violation which is the subject of the action to the Attorney General and the district attorney and any city attorney in whose jurisdiction the violation is alleged to occur and to the alleged violator, and (2) neither the Attorney General nor any district attorney nor any city attorney or prosecutor has commenced and is diligently prosecuting an action against such violation.”

3.   The Toxic Enforcement Act authorizes injunctive relief, as well as civil penalties of up to $2,500 per day, per violation, for failure to comply with its warning requirements.  (Health & Saf.Code, § 25249.7, subds. (a), (b).)   The Unfair Competition Act also authorizes injunctive relief to prevent unfair, unlawful or fraudulent business acts or practices, as well as restitution of money or property wrongfully obtained.  (State Farm Fire & Casualty Co. v. Superior Court (1996) 45 Cal.App.4th 1093, 1102, 53 Cal.Rptr.2d 229.)

4.   Thus, the finality of the judgment depended upon defendants' compliance with the reformulation provision by a date certain.   There is nothing in the record to indicate the San Francisco judgment did not become final.

5.   The Attorney General, who approved the settlement in the San Francisco action, has filed an amicus curiae brief herein.   Additionally, the California Chamber of Commerce has submitted an amicus brief in support of AII and Combe.

6.   Paragraph 13 defined the Compliance Date as “July 31, 1998 or five months after the Trigger Date, whichever is later.”

7.   In addition to protecting defendants from adverse publicity, the nondisclosure provision presumably was aimed at averting damage claims by individual consumers, and at precluding consumers from attempted intervention in the San Francisco action before the judgment would become final.

8.   The issue of class certification is not before us.

9.   Although defendants raised the issue of the FDCA on their motion for judgment on the pleadings, it does not appear the trial court spoke to that issue.   In any event, the applicability of the FDCA was raised below as well as in this proceeding and the issue is properly before us.

10.   The doctrine of “collateral estoppel is one aspect of the concept of res judicata.   In modern usage, however, the two terms have distinct meanings.   The Restatement Second of Judgments, for example, describes collateral estoppel as ‘issue preclusion’ and res judicata as ‘claim preclusion.’  (Rest.2d Judgments, § 27.)”  (Lucido v. Superior Court (1990) 51 Cal.3d 335, 341, fn. 3, 272 Cal.Rptr. 767, 795 P.2d 1223.)

11.   We express no view as to whether a settlement participated in or approved by a local public prosecutor would compel the same conclusion.

12.   The Attorney General agrees with this analysis.   Its amicus curiae brief states:  “[I]f the original Proposition 65 [Toxic Enforcement Act] action alleged and settled a claim based on a failure to provide a Proposition 65 warning for lead exposure, and remedied the general harm to consumers who purchased the product and were not given the warning, this first action would not be res judicata as to a subsequent action that seeks compensatory damages for purchasers who were actually injured by the product, e.g., were poisoned by the lead in the product.”

13.   To the extent the Urbach plaintiffs' causes of action are barred by res judicata, it is unnecessary to address whether they would also be barred by the FDCA.

14.   We note defendants do not contend the sixth cause of action alleging products liability is barred by the FDCA.

15.   21 Code of Federal Regulations section 73.2396 (1998), pertaining to lead acetate, states in relevant part:  “(c) Uses and restrictions.   The color additive lead acetate may be safely used in cosmetics intended for coloring hair on the scalp only, subject to the following restrictions:  [¶] (1) The amount of the lead acetate in the cosmetic shall be such that the lead content, calculated as Pb, shall not be in excess of 0.6 percent (weight to volume).  [¶] (2) The cosmetic is not to be used for coloring mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. [¶] (d) Labeling requirements.   [¶] (1) The label of the color additive lead acetate shall conform to the requirements of § 170.25 of this chapter, and bear the following statement or equivalent:  [¶] Wash thoroughly if the product comes into contact with the skin.  [¶] (2) The label of the cosmetic containing the color additive lead acetate, in addition to other information required by the act, shall bear the following cautionary statement, conspicuously displayed thereon:  [¶] CAUTION:  Contains lead acetate.   For external use only.   Keep this product out of children's reach.   Do not use on cut or abraded scalp.   If skin irritation develops, discontinue use.   Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp.   Do not get in eyes.   Follow instructions carefully and wash hands thoroughly after each use. [¶] (e) Exemption for certification.   Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.”  (Certain italics added.)

16.   21 Code of Federal Regulations section 740.10 (1998), pertaining to cosmetic product warning statements, provides:  “(a) Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing.   Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel:  [¶] Warning-The safety of this product has not been determined. [¶] (b) An ingredient or product having a history of use in or as a cosmetic may at any time have its safety brought into question by new information that in itself is not conclusive.   The warning required by paragraph (a) of this section is not required for such an ingredient or product if:  [¶] (1) The safety of the ingredient or product had been adequately substantiated prior to development of the new information;  [¶] (2) The new information does not demonstrate a hazard to human health;  and [¶] (3) Adequate studies are being conducted to determine expeditiously the safety of the ingredient or product. [¶] (c) Paragraph (b) of this section does not constitute an exemption to the adulteration provisions of the Act or to any other requirement in the Act or this chapter.”  (Second italics added.)

KLEIN, P.J.

CROSKEY, J., and ALDRICH, J., concur.