This is the tenth blog in a blogs to address The Safe Cosmetics Act H.R. 2359. Links to all of the other blog posts in this series can be found here.
KEY: All Plain Text is directly from H.R. 2359 as it is written, Yellow is from the FDA regulations and green is my commentary.
‘‘SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED COSMETICS.
‘‘(a) NOTIFICATION OF ADULTERATED OR MISBRANDED COSMETICS.—
‘‘(1) IN GENERAL.—A responsible party that has reason to believe that a cosmetic, when introduced into or while in interstate commerce, or while held for sale (regardless of whether such sale is the first sale of such cosmetic) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health effects or death to humans shall notify the Secretary of the identity and location of the cosmetic.
Talk about the wild, wild West of cosmetics. According to this ANY “responsible party” that has ANY “reason to believe that a cosmetic” is adulterated or misbranded by the definitions of this new legislation and has ANY reason to “present a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health effects or death to humans” has the right to turn your into the Secretary. It will be your duty to defend yourself against ANY and ALL inaccurate “probability” that someone has that your product will cause “adverse health effects or death to humans” despite the fact that no cosmetics EVER have!
Right now, if you are not scared yet, you should be terrified of this legislation! The EWG and CFSC will no longer have to just make internet scares and claims to mislead the public. They will be able to make claims against specific products despite the lack of science, health risk or history of damage caused by cosmetics.
‘‘(3) RESPONSIBLE PARTY DEFINED.—For purposes of this subsection, the term ‘responsible party’ means a manufacturer, packager, retailer, or distributor of the cosmetic.
This subsection below or above? If it is above then all the EWG or CFSC has to do is distribute a cosmetic in order to be classified here.
“(b) VOLUNTARY RECALL.—The Secretary may request that any person who distributes a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily—
‘‘(1) recall such cosmetic; and
‘‘(2) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.
All cosmetic companies already have this right.
‘‘(c) ORDER TO CEASE DISTRIBUTION.—
‘‘(1) IN GENERAL.—If the Secretary has reason to believe that—
‘‘(A) the use of, or exposure to, a cosmetic may cause serious adverse health effects or death to humans;
‘‘(B) the cosmetic is misbranded; or
‘‘(C) the cosmetic is manufactured, packaged, or distributed by an unregistered facility; the Secretary shall have the authority to issue an order requiring any person who distributes such cosmetic to immediately cease distribution of such cosmetic.
The big question is who and what gives cause for the Secretary to “believe” this?
‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any person who is subject to an order under paragraph
(1) shall immediately cease distribution of such cosmetic and provide notification as required by such order.
‘‘(3) APPEAL.—
‘‘(A) 24 HOURS.—A person subject to an order under paragraph (1) may appeal such order to the Secretary within 24 hours of the issuance of such order.
This doesn’t even give room for it to be a 24 hour period on a business day. What if this all happens late Friday night and no one checks their email, phone messages or other means of communication until Monday.
And even if it is a weekday you are given 24 hours to defend yourself and your company whether the claim in true or untrue. I’m thinking a few lawyers might be salivating at the inclusion of this segment.
‘‘(B) CONTENTS OF APPEAL.—Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).
‘‘(C) INFORMAL HEARING.—Except as provided in subsection (e), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days (or less as determined by the Secretary) after such an appeal is filed, unless the parties jointly agree to an extension.
‘‘(D) IMPACT ON RECALL.—If an appeal is filed under subparagraph (A), the Secretary may not amend the order to require a recall under subsection (d) until after the conclusion of the hearing under subparagraph (C).
‘‘(4) VACATION OF ORDER.—If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph
(1), the Secretary shall vacate the order.
‘‘(d) ORDER TO RECALL.—
‘‘(1) AMENDMENT.—Except as provided under subsection (e) and subject to subsection (c)(3)(D), if the Secretary determines that a recall of a cosmetic subject to an order under subsection (c) is appropriate, the Secretary shall amend the order to require a recall.
‘‘(2) CONTENTS.—An amended order under paragraph (1) shall—
‘‘(A) specify a timetable in which the recall will occur;
‘‘(B) require periodic reports to the Secretary describing the progress of the recall; and
‘‘(C) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.
In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.
‘‘(3) NONDELEGATION.—An amended order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.
This Secretary is going to need to be superhuman. They can’t even delegate any duties. Anyone have the phone number for Batman? He should apply for the job.
‘‘(4) DETERMINATION.—If the Secretary determines that inadequate grounds exist to support the amendment made to the order under paragraph (1), the Secretary shall remove such amendment from such order.
‘‘(e) EMERGENCY RECALL ORDER.—
‘‘(1) IN GENERAL.—If the Secretary has credible evidence or information that a cosmetic subject to an order under subsection (c) presents an imminent threat of serious adverse health effects or death to humans, the Secretary may issue an order requiring any person who distributes such cosmetic—
‘‘(A) to immediately recall such cosmetic; and
‘‘(B) to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.
This sounds very familiar, similar to the language of the Food Modernization Act. This would require that a manufacturer kept track of every customer and potential customers.
‘‘(2) RECALL AND NOTICE.—Any person who is subject to an emergency recall order under this subsection shall immediately recall such cosmetic and provide notification as required by such order.
‘‘(3) APPEAL.—
‘‘(A) 24 HOURS.—Any person subject to such an order may appeal such order to the Secretary within 24 hours of the issuance of such order.
‘‘(B) CONTENTS OF APPEAL.—Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).
‘‘(C) INFORMAL HEARING.—An informal hearing shall be held as soon as practicable after the appeal is filed under subparagraph
(A), but not later than 5 calendar days after such an appeal is filed, or fewer days (as determined by the Secretary), unless the parties jointly agree to an extension.
‘‘(4) VACATION OF ORDER.—If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph
(1), the Secretary shall vacate the order.
‘‘(5) NONDELEGATION.—An order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.
‘‘(f) NOTICE TO CONSUMERS AND HEALTH OFFICIALS.—The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the cosmetic was, or may have been, distributed and to appropriate State and local health officials.
‘‘(g) SUPPLY CHAIN INFORMATION.—
‘‘(1) IN GENERAL.—In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, the Secretary shall request that the entity named on the label of such cosmetic (as required under section 602(b)(1)) submit all of the following information:
‘‘(A) The name and place of business of the manufacturer, packer, or distributor from which such entity received the cosmetic or ingredients for manufacturing such cosmetic.
This would require a company has the products private labeled to disclose publically who their private label house is.
‘‘(B) The name and place of business of any entity (including any retailer) that was provided with such cosmetic by the entity named on the label.
‘‘(2) COLLECTION OF ADDITIONAL SUPPLY CHAIN INFORMATION.—In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, to the extent necessary to protect the safety of the public, the Secretary may request that any entity (including a supplier of an ingredient, manufacturer, packer, distributor, or retailer) in the supply chain of such cosmetic submit to the Secretary information that is similar to the information described under subparagraphs (A) and (B) of paragraph (1).
Now everyone in the entire chain must review their suppliers – just in case we missed any data any place else.
‘‘(3) MAINTENANCE OF RECORDS.—Any entity in supply chain of a cosmetic (including the entity named on the label of a cosmetic) shall—
‘‘(A) maintain records sufficient to provide the information described in subparagraphs (A) and (B) of paragraph (1); and
‘‘(B) provide such information to the Secretary upon the request of the Secretary.
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this section shall be construed as limiting the authority of the Secretary to issue an order to cease distribution of, or to recall, a cosmetic under any other provision of this Act.
I’m not a lawyer and this section really needs a good lawyer to look over and advise on, but I shared the parts that stand out to me.
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Posted by: Simekerce | February 02, 2012 at 12:49 AM
Can't anyone who thinks there's something wrong with a cosmetic product today already contact the FDA to complain?
Also interesting that the FDA can order any unregistered company to cease and desist manufacturing -- that should say, any "non-exempt unregistered company." That's a minor detail of course, but it does make me wonder about how unregistered companies will be viewed generally. Hmmmm ...
Oh, I'll have to read this over and over to make it all make sense (like you obviously already did ...)
Posted by: Donna Maria Coles Johnson | July 05, 2011 at 08:34 PM