SB39 - Cosmetic safety: vaginal suppositories.

Senate Bill No. 39 CHAPTER 208 An act to amend Sections 108980 and 108982 of the Health and Safety Code, relating to public health, and declaring the urgency thereof, to take effect immediately. [ Approved by Governor October 01, 2025. Filed with Secretary of State October 01, 2025. ] LEGISLATIVE COUNSEL'S DIGEST SB 39, Weber Pierson. Cosmetic safety: vaginal suppositories. Existing law, beginning on January 1, 2027, prohibits a person or entity from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product that contains any of several specified intentionally added ingredients, including boric acid, except under specified circumstances. This bill would extend that prohibition to January 1, 2035, for vaginal suppositories containing intentionally added boric acid. The bill would require, beginning on January 1, 2027, any vaginal suppository product containing boric acid to include a product label, as defined, warning consumers that the product should not be used during pregnancy and other specified conditions. The bill would also exempt a vaginal suppository product from the above-mentioned prohibitions if the product becomes regulated by the United States Food and Drug Administration. The bill would make related findings and declarations. This bill would incorporate additional changes to Section 108980 of the Health and Safety Code proposed by AB 60 to be operative only if this bill and AB 60 are enacted and this bill is enacted last. This bill would declare that it is to take effect immediately as an urgency statute. Digest Key Vote: 2/3 Appropriation: NO Fiscal Committee: NO Local Program: NO Bill Text The people of the State of California do enact as follows: SECTION 1. The Legislature finds and declares all of the following: (a) According to published research from Johns Hopkins University, intravaginal boric acid represents one of the few available options for addressing recurrent vaginal yeast and bacterial infections, including infections caused by azole-resistant Candida and nitroimidazole-resistant Trichomoniasis. Intravaginal boric acid is included in multiple national guidelines for addressing infectious vaginitis, including guidelines issued by the American College of Obstetricians and Gynecologists and the federal Centers for Disease Control and Prevention. (b) Research suggests that intravaginal boric acid is well tolerated for use in addressing recurrent vaginal infections. However, little is known about the safety of intravaginal boric acid use during pregnancy, and animal studies show that high levels of oral exposure are associated with increased risk of birth defects. As a result, guidelines issued by the American College of Obstetricians and Gynecologists and health care professional associations in other countries, including Canada and the United Kingdom, recommend against intravaginal boric acid use during pregnancy, or recommend that persons use reliable contraception while using intravaginal boric acid. (c) Existing state law bans, beginning January 1, 2027, the manufacture and sale of any cosmetic product containing specified chemicals as intentionally added ingredients, including boric acid. Because the use of intravaginal boric acid represents one of the few available options for addressing recurrent vaginal infections, additional time for vaginal suppository products containing intentionally added boric acid is warranted to allow these products time to become regulated as a drug under the United States Food and Drug Administration. SEC. 2. Section 108980 of the Health and Safety Code is amended to read: 108980. (a) Commencing January 1, 2025, no person or entity shall manufacture, sell, deliver, hold, or offer for sale in commerce any cosmetic product that contains any of the following intentionally added ingredients: (1) Dibutyl phthalate (CAS no. 84-74-2). (2) Diethylhexyl phthalate (CAS no. 117-81-7). (3) Formaldehyde (CAS no. 50-00-0). (4) Paraformaldehyde (CAS no. 30525-89-4). (5) Methylene glycol (CAS no. 463-57-0). (6) Quaternium-15 (CAS no. 51229-78-8). (7) Mercury (CAS no. 7439-97-6). (8) Isobutylparaben (CAS no. 4247-02-3). (9) Isopropylparaben (CAS no. 4191-73-5). (10) m-Phenylenediamine and its salts (CAS no. 108-45-2). (11) o-Phenylenediamine and its salts (CAS no. 95-54-5). (12) The following per- and polyfluoroalkyl substances (PFAS) and their salts: (A) Perfluorooctane sulfonate (PFOS); heptadecafluorooctane-1-sulfonic acid (CAS no. 1763-23-1). (B) Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate (CAS no. 2795-39-3). (C) Diethanolamine perfluorooctane sulfonate (CAS 70225-14-8). (D) Ammonium perfluorooctane sulfonate; ammonium heptadecafluorooctanesulfonate (CAS 29081-56-9). (E) Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate (CAS 29457-72-5). (F) Perfluorooctanoic acid (PFOA)(CAS no. 335-67-1). (G) Ammonium pentadecafluorooctanoate (CAS no. 3825-26-1). (H) Nonadecafluorodecanoic acid (CAS no. 355-76-2). (I) Ammonium nonadecafluorodecanoate (CAS no. 3108-42-7). (J) Sodium nonadecafluorodecanoate (CAS no. 3830-45-3). (K) Perfluorononanoic acid (PFNA)(CAS no. 375-95-1). (L) Sodium heptadecafluorononanoate (CAS no. 21049-39-8). (M) Ammonium perfluorononanoate (CAS no. 4149-60-4). (b) Except as provided in paragraph (2) of subdivision (e), commencing January 1, 2027, no person or entity shall manufacture, sell, deliver, hold, or offer for sale in commerce any cosmetic product that contains any of the following intentionally added ingredients: (1) Lily aldehyde (CAS no. 80-54-6). (2) Acetaldehyde (CAS no. 75-07-0). (3) Cyclohexylamine (CAS no. 108-91-8). (4) Cyclotetrasiloxane (CAS no. 556-67-2). (5) Phytonadione (CAS no. 84-80-0). (6) Sodium perborate (CAS no. 15120-21-5). (7) Styrene (CAS no. 100-42-5). (8) Trichloroacetic acid (CAS no. 76-03-9). (9) Tricresyl phosphate (CAS no. 1330-78-5). (10) Vinyl acetate (CAS no. 108-05-4). (11) 2-Chloracetamide (CAS no. 79-07-2). (12) Allyl isothiocyanate (CAS no. 57-06-7). (13) Anthraquinone (CAS no. 84-65-1). (14) Malachite green (CAS no. 569-64-2). (15) Oil from the seeds of Laurus nobilis L. (CAS no. 84603-73-6). (16) Pyrogallol (CAS no. 87-66-1). (17) C.I. disperse blue 1 (CAS no. 2475-45-8). (18) Trisodium nitrilotriacetate (CAS no. 5064-31-3). (19) The following boron substances: (A) Perboric acids: (i) Sodium salt (CAS no. 11138-47-9). (ii) Sodium salt, monohydrate (CAS no. 12040-72-1). (iii) Sodium perborate monohydrate (CAS no. 10332-33-9). (B) Boric acid (CAS nos. 10043-35-3 and 11113-50-1). (C) Borates, tetraborates, octaborates, and boric acid salts and esters, including all of the following: (i) Disodium octaborate anhydrous (CAS no. 12008-41-2). (ii) Disodium octaborate tetrahydrate (CAS no. 12280-03-4). (iii) 2-Aminoethanol, monoester with boric acid (CAS no. 10377-81-8). (iv) 2-Hydroxypropyl ammonium dihydrogen orthoborate (CAS no. 68003-13-4). (v) Potassium borate, boric acid potassium salt (CAS no. 12712-38-8). (vi) Trioctyldodecyl borate. (vii) Zinc borate (CAS no. 1332-07-6). (viii) Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt (CAS no. 1330-43-4). (ix) Tetraboron disodium heptaoxide, hydrate (CAS no. 12267-73-1). (x) Orthoboric acid, sodium salt (CAS no. 13840-56-7). (xi) Disodium tetraborate decahydrate; borax decahydrate (CAS no. 1303-96-4). (xii) Disodium tetraborate pentahydrate; borax pentahydrate (CAS no. 12179-04-3). (20) C.I. disperse blue 3 (CAS no. 2475-46-9). (21) Basic green 1 (CAS no. 633-03-4). (22) Basic blue 7 (CAS no. 2390-60-5). (23) 3(or5)-((4-(benzylmethylamino)phenyl)azo)-1,2 -(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts (CAS nos. 89959-98-8 and 12221-69-1). (24) Basic violet 4 (CAS no. 2390-59-2). (25) Basic blue 3 (CAS no. 33203-82-6). (26) Basic blue 9 (CAS no. 61-73-4). (c) If a cosmetic product made through manufacturing processes intended to comply with this chapter contains a technically unavoidable trace quantity of an ingredient listed in subdivision (a) or (b) and that trace quantity stems from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging, that trace quantity shall not cause the cosmetic product to be in violation of this section. (d) For purposes of this section, “ingredient” has the same meaning as defined in Section 111791.5. (e) (1) Commencing January 1, 2027, a person or entity that manufactures, sells, delivers, holds, or offers for sale in commerce a vaginal suppository product containing intentionally added boric acid (CAS nos. 10043-35-3 and 11113-50-1) shall include on the product label the following statement: “WARNING: IT IS RECOMMENDED TO CONSULT WITH A DOCTOR BEFORE USE, particularly if you have sensitivity in your lower pelvis or abdomen, a sexually transmitted disease (STD), pelvic inflammatory disease (PID), vaginal bleeding, sores, ulcerations, nausea, fever, or chills. Do not use on broken or irritated skin. Stop use and contact a doctor if symptoms persist or worsen, or if you experience irritation, burning, bleeding, or cramping. NOT FOR ORAL CONSUMPTION. FOR VAGINAL USE ONLY. DO NOT USE IF PREGNANT, TRYING TO CONCEIVE, OR NURSING. IF YOU BECOME PREGNANT WHILE USING THIS PRODUCT, DISCONTINUE USE IMMEDIATELY. If swallowed, get medical help or contact Poison Control Center immediately. Some boric acid suppository products may break down a condom—ensure product has completely dissolved before having sex.” (2) Commencing January 1, 2035, no person or entity shall manufacture, sell, deliver, hold, or offer for sale in commerce a vaginal suppository product that contains intentionally added boric acid (CAS nos. 10043-35-3 and 11113-50-1). (3) Paragraphs (1) and (2) shall not apply to a vaginal suppository product containing intentionally added boric acid (CAS nos. 10043-35-3 and 11113-50-1) if the product becomes regulated as a drug by the United States Food and Drug Administration. SEC. 2.5. Section 108980 of the Health and Safety Code is amended to read: 108980. (a) Commencing January 1, 2025, a person or entity shall not manufacture, sell, deliver, hold, or offer for sale in commerce any cosmetic product that contains any of the following intentionally added ingredients: (1) Dibutyl phthalate (CAS no. 84-74-2). (2) Diethylhexyl phthalate (CAS no. 117-81-7). (3) Formaldehyde (CAS no. 50-00-0). (4) Paraformaldehyde (CAS no. 30525-89-4). (5) Methylene glycol (CAS no. 463-57-0). (6) Quaternium-15 (CAS no. 51229-78-8). (7) Mercury (CAS no. 7439-97-6). (8) Isobutylparaben (CAS no. 4247-02-3). (9) Isopropylparaben (CAS no. 4191-73-5). (10) m-Phenylenediamine and its salts (CAS no. 108-45-2). (11) o-Phenylenediamine and its salts (CAS no. 95-54-5). (12) The following per- and polyfluoroalkyl substances (PFAS) and their salts: (A) Perfluorooctane sulfonate (PFOS); heptadecafluorooctane-1-sulfonic acid (CAS no. 1763-23-1). (B) Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate (CAS no. 2795-39-3). (C) Diethanolamine perfluorooctane sulfonate (CAS 70225-14-8). (D) Ammonium perfluorooctane sulfonate; ammonium heptadecafluorooctanesulfonate (CAS 29081-56-9). (E) Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate (CAS 29457-72-5). (F) Perfluorooctanoic acid (PFOA)(CAS no. 335-67-1). (G) Ammonium pentadecafluorooctanoate (CAS no. 3825-26-1). (H) Nonadecafluorodecanoic acid (CAS no. 355-76-2). (I) Ammonium nonadecafluorodecanoate (CAS no. 3108-42-7). (J) Sodium nonadecafluorodecanoate (CAS no. 3830-45-3). (K) Perfluorononanoic acid (PFNA)(CAS no. 375-95-1). (L) Sodium heptadecafluorononanoate (CAS no. 21049-39-8). (M) Ammonium perfluorononanoate (CAS no. 4149-60-4). (b) Except as provided in paragraph (2) of subdivision (f), commencing January 1, 2027, no person or entity shall manufacture, sell, deliver, hold, or offer for sale in commerce any cosmetic product that contains any of the following intentionally added ingredients: (1) Lily aldehyde (CAS no. 80-54-6). (2) Acetaldehyde (CAS no. 75-07-0). (3) Cyclohexylamine (CAS no. 108-91-8). (4) Cyclotetrasiloxane (CAS no. 556-67-2). (5) Phytonadione (CAS no. 84-80-0). (6) Sodium perborate (CAS no. 15120-21-5). (7) Styrene (CAS no. 100-42-5). (8) Trichloroacetic acid (CAS no. 76-03-9). (9) Tricresyl phosphate (CAS no. 1330-78-5). (10) Vinyl acetate (CAS no. 108-05-4). (11) 2-Chloracetamide (CAS no. 79-07-2). (12) Allyl isothiocyanate (CAS no. 57-06-7). (13) Anthraquinone (CAS no. 84-65-1). (14) Malachite green (CAS no. 569-64-2). (15) Oil from the seeds of Laurus nobilis L. (CAS no. 84603-73-6). (16) Pyrogallol (CAS no. 87-66-1). (17) C.I. disperse blue 1 (CAS no. 2475-45-8). (18) Trisodium nitrilotriacetate (CAS no. 5064-31-3). (19) The following boron substances: (A) Perboric acids: (i) Sodium salt (CAS no. 11138-47-9). (ii) Sodium salt, monohydrate (CAS no. 12040-72-1). (iii) Sodium perborate monohydrate (CAS no. 10332-33-9). (B) Boric acid (CAS nos. 10043-35-3 and 11113-50-1). (C) Borates, tetraborates, octaborates, and boric acid salts and esters, including all of the following: (i) Disodium octaborate anhydrous (CAS no. 12008-41-2). (ii) Disodium octaborate tetrahydrate (CAS no. 12280-03-4). (iii) 2-Aminoethanol, monoester with boric acid (CAS no. 10377-81-8). (iv) 2-Hydroxypropyl ammonium dihydrogen orthoborate (CAS no. 68003-13-4). (v) Potassium borate, boric acid potassium salt (CAS no. 12712-38-8). (vi) Trioctyldodecyl borate. (vii) Zinc borate (CAS no. 1332-07-6). (viii) Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt (CAS no. 1330-43-4). (ix) Tetraboron disodium heptaoxide, hydrate (CAS no. 12267-73-1). (x) Orthoboric acid, sodium salt (CAS no. 13840-56-7). (xi) Disodium tetraborate decahydrate; borax decahydrate (CAS no. 1303-96-4). (xii) Disodium tetraborate pentahydrate; borax pentahydrate (CAS no. 12179-04-3). (20) C.I. disperse blue 3 (CAS no. 2475-46-9). (21) Basic green 1 (CAS no. 633-03-4). (22) Basic blue 7 (CAS no. 2390-60-5). (23) 3(or5)-((4-(benzylmethylamino)phenyl)azo)-1,2 -(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts (CAS nos. 89959-98-8 and 12221-69-1). (24) Basic violet 4 (CAS no. 2390-59-2). (25) Basic blue 3 (CAS no. 33203-82-6). (26) Basic blue 9 (CAS no. 61-73-4). (27) Musk ambrette (CAS no. 83-66-9). (28) Musk tibetene (CAS no.145-39-1). (29) Musk moskene (CAS no. 116-66-5). (30) Musk xylene (CAS no. 81-15-2). (c) (1) Commencing January 1, 2027, a person or entity shall not manufacture, sell, deliver, hold, or offer for sale in commerce a cosmetic product that contains more than 1.4 percent in fine fragrance products, 0.56 percent in eau de toilette, 0 percent in oral products, and 0.042 percent in all other products of musk ketone (CAS no. 81-14-1). (2) “Oral products” means a cosmetic product that is intended to be applied on teeth or the mucous membranes of the oral cavity. (d) If a cosmetic product made through manufactur [Text truncated for display. Full text available on Congress.gov.]