On August 24, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Sunny Wholesale, Inc. (Respondent), of Forest Park, Georgia. ALJ Ex. 6. The Order immediately suspended Respondent's DEA Certificate of Registration, No. 004550SLY, which authorizes it to distribute the list I chemicals ephedrine and pseudoephedrine, on the ground that it was selling “excessive amounts” of these chemicals to convenience stores,
More specifically, the Show Cause Order alleged that in July 2005, DEA Diversion Investigators (DIs) learned that records seized from various north Georgia convenience stores which were “suspected of illegally distributing listed chemical precursors,” had “indicated that [Respondent] had been distributing 60 count bottles of” Max Brand pseudoephedrine, a product which has been repeatedly found at illicit methamphetamine labs “in full case and double case lots.”
In addition to the above, the Show Cause Order alleged that during a July 2001 inspection, DEA DIs audited Respondent's handling of listed chemical products and determined that it had “various overages and shortages, including an unexplained shortage of approximately 10,000 bottles of Max Brand, and (another non-traditional brand)
The Show Cause Order further alleged that following the inspection, DEA DIs conducted verifications of Respondent's customers; the DIs allegedly found that some of the locations were “non-existent,” some were residences, and others included such establishments as “liquor stores, gift shops, a Blimpie restaurant * * * and a magazine store.”
The Show Cause Order also alleged that Respondent would not maintain proper security of listed chemical products at its new proposed location because while its owner, Mr. Shaukat Sayani, had represented that his customers would place their orders “in person” and that Respondent would deliver the products by van, the DIs had previously determined that Respondent did not conduct business in this “manner at [its] Forest Park” location.
On September 13, 2005, Respondent requested a hearing on the allegations of the Order to Show Cause and Immediate Suspension and moved to consolidate the two proceedings. ALJ Ex. 7. While the hearing on the original Show Cause Order had been scheduled to begin on September 20, 2005, Respondent's counsel sought a continuance to obtain additional time to prepare. Accordingly, the ALJ ordered that the original hearing be cancelled. On December 14, 2005, the ALJ conducted a pre-hearing conference and set the hearing for March 21, 2006. ALJ Decision (ALJ) at 2–3.
Thereafter, on February 27, 2006, Respondent's counsel filed an emergency motion for a continuance. The ALJ granted the motion and subsequently rescheduled the hearing to begin on August 15, 2006.
A hearing was held on August 15 through 18, 2006, at which both parties called witnesses to testify and submitted documentary evidence. At the hearing, Respondent also submitted a motion for summary judgment.
On May 4, 2007, the ALJ ordered the parties to file a joint status report regarding Respondent's Forest Park registration. On June 11, 2007, the parties filed the report; the report stated that “it is the position of the agency and Respondent that [it] currently has a pending application for renewal of its currently suspended registration.” Joint Status Report at 2.
On August 17, 2007, the ALJ issued her recommended decision. In her decision, the ALJ concluded that Respondent did not maintain effective controls against diversion because it did not “verify the legitimacy of its customers,” sold “suspiciously high quantities of iodine products to some customers” even though its owner “was repeatedly made aware of iodine's role as a methamphetamine precursor,” had “inadequate inventory procedures [and] poor recordkeeping,” and failed “to report suspicious transactions.”
The ALJ also concluded that Respondent was not in compliance with federal law because it “could not account for large quantities of missing bottles of product,” and “did not keep adequate records” of its sales which “hindered [its] ability to ascertain whether a customer had purchased an amount above the regulated threshold.”
The ALJ did note that Respondent had improved its security and had “conduct[ed] some investigations into some of its customers' business identities.”
The ALJ further rejected Respondent's arguments that the Government was denying it equal protection of the laws under the Due Process Clause of the Fifth Amendment. More specifically, Respondent argued that it was being held “ ‘to a different standard than [the Government's] published rules dictate,’ ”
Finally, the ALJ rejected Respondent's contention that it was entitled to judgment as a matter of law because its sales did not exceed the 1,000 gram monthly threshold (which triggers various reporting and recordkeeping) requirements.
While the ALJ did not make an express finding that Respondent's continued registration is inconsistent with the public interest, such a finding is implicit in her recommended sanction that Respondent's registration at its Forest Park location should be revoked and its pending application for a registration at its Decatur location should be denied. ALJ at 38. Thereafter, both parties filed exceptions to the ALJ's decision.
The Government's exception noted that while it concurred with the ALJ's recommendation, it was “not apparent whether the ALJ actually made a finding that Respondent's continued registration would not be in the public interest.” Gov. Exceptions at 1. The Government thus requested that I “make a finding that Respondent's continued registration and pending application for registration are not in the public interest as that term is used” in the applicable provisions of the Controlled Substances Act.
The Government also took exception to three of the ALJ's factual findings (FOFs 52, 57, 58), pertaining to the testimony of the Government's expert on the expected sale range of listed chemical products at convenience stores and other non-traditional retailers of these products.
Because “Respondent sold in excess of both experts' figures,” the Government declined to “opine” as to
In its exceptions, Respondent also noted that the ALJ had not made a finding as to whether its continued registration would be in the public interest and argued that “no such ruling would be appropriate in this matter.” Resp. Exceptions at 2. More specifically, Respondent contends that it has “complied with every request that was given to it by the DEA, repeatedly requested of DEA what they wanted it to do and was willing to do anything the DEA wanted.”
Respondent also takes exception to the ALJ's finding that it has “inadequate inventory procedures.”
Thereafter, the record was forwarded to me for final agency action. Having considered the record as a whole, as well as the exceptions of both parties, I adopt the ALJ findings of fact except as expressly noted herein. I further conclude that the Government has made out a
Respondent is a corporation which engages in the wholesale distribution of assorted products to gas stations, convenience stores, dollar stores, beauty stores, and other establishments. Tr. 701. Respondent is owned by Mr. Sunny Sayani,
Respondent currently holds DEA Certificate of Registration, # 004550SLY, which authorizes it to distribute the list I chemicals ephedrine and pseudoephedrine out of its Forest Park warehouse. Tr. 245; GX 1. While Respondent's registration expired on February 28, 2005, it filed a renewal application and paid the requisite fee at some point in January 2005. See Joint Status Report at 1–2. Accordingly, Respondent has a registration, albeit one that has been suspended, at its Forest Park location.
Both pseudoephedrine and ephedrine have therapeutic uses and are lawfully marketed as non-prescription (OTC) drug products under the Federal Food, Drug and Cosmetic Act. GX 15, at 3. Pseudoephedrine is approved for marketing as a decongestant; ephedrine (in combination with guaifenesin) is approved for marketing as a bronchodilator.
Methamphetamine is a highly addictive and abused central-nervous system stimulant. GX 15, at 9. Methamphetamine abuse has destroyed numerous lives and families and ravaged communities.
A DEA Special Agent from the Atlanta Field Division testified regarding the rapid growth of illicit manufacturing of methamphetamine during his tenure in Atlanta. Tr. 29. According to the S/A's testimony, over “a short period of time” the number of meth. lab seizures by DEA and local law enforcement had “multiplied by ten times.”
The Special Agent, who had debriefed over 200 individuals involved in the illicit manufacture of methamphetamine, Tr. 39, also testified that convenience stores, gas stations, and other small retailers were the primary source of the ephedrine and pseudoephedrine which was used by “mom-and-pop” meth. labs.
The S/A also testified that in some instances, meth. cooks recruited multiple persons to go to smaller stores and buy the maximum amount of product the store would sell them.
The Government also established that the overwhelming majority of commerce in non-prescription drug products occurs in drug stores, supermarkets, large discount merchandisers and electronic shopping/mail order houses. GX 25. According to the declaration of Jonathan Robbin,
Mr. Robbin has further concluded that sales of non-prescription drugs at convenience stores “account for only 2.2% of the overall sales of all convenience stores that handle the line.”
Respondent called as an expert witness, Dr. Danny N. Bellenger. Dr. Bellenger holds a PhD in Business Administration and is a Professor and Marketing Research Fellow at the Robinson College of Business at Georgia State University. RX 31, at 2. Dr. Bellenger previously served as chairman of the Department of Marketing at Robinson, and was the Dean of the College of Business at Auburn University.
Dr. Bellenger disputed Mr. Robbin's figures for the expected monthly sales range of pseudoephedrine at convenience stores. Dr. Bellenger testified that he did not agree with the conclusions of Mr. Robbin's reports and that reports did not “agree with each other.” Tr. 521. More specifically, Dr. Bellenger noted that one of Mr. Robbin's reports stated that “two in 1,000 * * * convenience store shoppers would be expected to buy Sudafed,” but in another report, Mr. Robbin had stated “that there's 120,000 purchasers or customers [who] come into a convenience store.”
Dr. Bellenger explained that if two out of a 1,000 customers purchased pseudoephedrine and a convenience store has 120,000 customers, at least 240 of these persons would buy the product over the course of a year or “twenty per month for an average convenience store.” Tr. 523. Dr. Bellenger testified that multiplying this number “times the average retail price of * * * Sudafed” gives an “estimate of about $170 * * * based on the numbers that are in the reports.”
Dr. Bellenger subsequently testified that he determined the average price of Sudafed by “looking at the wholesale prices and assuming a markup,” and that he “also looked in Kroger to see what it cost, but [the price] would vary a lot * * * by store.”
Dr. Bellenger also testified that he confirmed his estimate by multiplying the percentage of convenience store shoppers who purchase pseudoephedrine (.0027) times the average annual merchandise sales of convenience stores ($770,000). Dividing this figure by twelve results in a monthly sales figure of $173.25, which is “a similar number” to the sales figure obtained in the first method.
Dr. Bellenger further testified that Mr. Robbin's methodology was based on several assumptions which he contended “are not consistent with reality.”
While the ALJ credited Dr. Bellenger's testimony that the monthly expected sales figure of pseudoephedrine products at convenience stores was $173.25,
Accordingly, I conclude that neither the Government's nor Respondent's evidence reliably establishes the monthly expected sales range.
Dr. Bellenger also testified regarding several other matters. With respect to the size of a retailer's purchases, Dr. Bellenger testified that buying a case quantity may be a legitimate business decision “to invest in more inventory so as to lower [its labor] cost of taking inventory and processing order forms.” Tr. 549. According to Dr. Bellenger:
The simple fact that someone, in * * * their business model, decides to order in large quantities is not necessarily suspicious in and of itself. What would be suspicious to me is if someone repeatedly ordered in large quantities. So I would think that looking for repeated large quantity orders by the same store or a combination of products which go into the production and ordering in large quantities * * * of a group of products which are involved in the manufacture of some illicit substance would be important for determining suspicious orders.
Amplifying this testimony, Dr. Bellenger added that to purchase a case quantity (144 bottles) is “one of two things. It's a conscious business decision where a store owner has decided it's more efficient to order in large quantities, put it in the stockroom, and make fewer orders, and have less labor involved.”
The ALJ also credited Dr. Bellenger's testimony that in reviewing the various exhibits, he noted that while “some of [Respondent's customers] were buying by case lot,” he did not find a pattern of the customers “buying [ten] 144s.” Tr. 571 (cited at ALJ at 25). Respondent's own evidence shows, however, that there were multiple instances in which Respondent sold case quantities that suggest that the sales were for an illicit purpose.
For example, during the year 2004, Respondent sold cases (144 bottles) of Max Brand Pseudo to the Coastal Food Mart of Rockmart, Georgia, on eight occasions: January 21, February 2, March 4, April 19, June 3, July 14, August 2, and September 5.
On re-direct, Dr. Bellenger opined that “it would be highly unlikely in the normal course of business” for an entity like Sunny Wholesale to detect these transactions.
The Coastal Food Mart was not, however, the only store to which Respondent repeatedly sold large quantities of pseudoephedrine. During the same year, it sold a case quantity to Chitra Inc.'s Quick Stop of Rome, Georgia, on eight separate dates: January 4, April 8, June 14, July 5, August 2, August 20, September 14, and October 11.
It sold a case to the R & S Grocery of Columbus on nine dates: January 21, February 2, March 2, April 1, May 5, June 21, July 7, August 30, and September 29.
Moreover, the record shows that there were instances in which Respondent sold to two customers who used the same address. For example, Respondent sold case quantities to the P & K Mini Mart, with an address of 461 Columbia Drive, Carrollton, on January 6, February 10, March 4, April 8, and May 5.
Relatedly, Dr. Bellenger testified that “unusual orders become very challenging if there's a relatively small number of * * * those orders * * * given the large numbers of people [a business is] dealing with.”
I reject Dr. Bellenger's testimony regarding the difficulty of detecting excessive purchases. As noted below, during an earlier meeting with DEA investigators, Mr. Sayani stated that “a typical sale” of listed] chemicals “was two to three boxes,” with each “box contain[ing] twelve bottles of 60-count tablets.”
Moreover, Respondent's records show that many of these customers were not trying to hide the size of their purchases by purchasing smaller quantities on different dates. Rather, they were openly ordering case quantities,
In September 1999, Respondent applied for a DEA registration to handle list I chemicals at its Forest Park warehouse. Tr. 703. Prior to being granted the registration, DEA DIs conducted a pre-registration inspection.
On January 31, 2001, Respondent applied for a registration to handle pseudoephedrine, ephedrine, and phenylpropanolamine, at its Decatur warehouse. GX 2. Accordingly, on March 31, 2001, DEA DIs went to Respondent's Decatur facility to conduct a pre-registration inspection. Tr. 246. During the inspection, the DIs met with Mr. Sayani and provided him with another copy of the
The DI had previously requested that Mr. Sayani provide her with lists of his suppliers, the products he intended to carry, and his proposed customers.
Respondent also listed three other suppliers; the listed chemical products he listed under these suppliers were nationally recognized brands such as Tylenol, Advil, Nyquil, Contac, and Vicks 44.
During the inspection, the DIs reviewed the
Based on Mr. Sayani's list of proposed customers, one of the DIs checked to see if DEA's computer system held information regarding the customers.
Moreover, the DIs' supervisor decided that before sending the report on the Decatur application to DEA Headquarters, the DIs needed to inspect Respondent's practices at its Forest Park warehouse because the location had “never been audited.”
Upon their arrival, the DIs met with Mr. Sayani and asked him to provide them with an inventory and a list of the listed chemical products Respondent distributed.
The DIs then proceeded to conduct an audit of Respondent's handling of list I products for the period January 1, 2001, through the close of business on June 30, 2001. GX 31. The DIs selected eleven non-traditional products to audit; with the assistance of Mr. Sayani, they counted the actual number on hand of each of the selected products. Tr. 264 & 275; GX 30.
To complete the audit, the DIs requested that Mr. Sayani provide them with his purchase invoices and sales invoices.
The audit found that there were shortages with respect to six of the eleven products.
Regarding the audit, Mr. Sayani testified that upon being served with the Show Cause Order, which had alleged that he was short approximately 10,000 bottles of Max Brand and Heads Up, he checked his July 2001 inventory and had 2069 bottles on hand and did not “know where this 10,000 figure came from.” Tr. 715. Mr. Sayani further testified that because 10,000 bottles is a large amount, he “would know where [it] is going.”
The ALJ did not make “precise findings” on the amount of the shortages. ALJ Dec. 30 at n.6. I do.
Notably, Mr. Sayani's testimony that he had 2069 bottles on hand according to his July 2001 inventory is consistent with the total amount of product that he and the DIs physically counted.
Moreover, for each of the audited products, the amount of the shortages (11,296 60-count bottles of Max Brand and Heads Up) was determined based on the discrepancy between the amount of these products which Respondent obtained from his suppliers during the audit period and the sum of the amount it had on hand on June 30 and the amount its sales records showed it had distributed during the audit period. Mr. Sayani's assertion aside, he offered no credible evidence that gives me reason to reject the audit's finding. Accordingly, I adopt as findings, the audit results as listed in GX 31.
As found above, during the visit, the DIs also discussed with Mr. Sayani the size of a normal monthly sale to a single store of non-traditional products.
Following the inspection, several DIs were assigned to conduct customer verifications.
One DI, who was assigned twelve verifications, found that several of the businesses were convenience stores, gas stations, and a liquor store. Tr. 142–45. Moreover, upon visiting the addresses of three of the customers, two of which were listed as businesses (Pamela's Unique Clothing and Reliance Wholesale Supply), and one which was listed as an individual (M.S.), the DI found that they were residences and that there were no signs of businesses. Tr. 142 & 144. The DI further found that the R.S. Corporation was a Blimpie restaurant,
Another DI testified that when she and her partner went looking for Ashley's Boutique, they could neither find the store nor the address that Mr. Sayani had given for it.
Another customer (BDI Inc.) was a Shell gas station whose manager stated that while he had purchased products from Respondent nine months earlier, he no longer did so.
Following the customer verifications, one of the DIs and her supervisor met with Mr. Sayani and his attorney Henry D. Frantz, Esq., to discuss their concerns that some of Respondent's customers were not legitimate.
Upon being informed by the DIs that “some of the customers were suspicious,” Mr. Sayani stated that he had “provided * * * a list of the customers he thought * * * would purchase from him, whether it was list I chemicals or other products that he handled.”
Several weeks thereafter, Respondent's attorney wrote a letter to the DIs reporting that 119 of the customers owned either a convenience store or grocery. RX 8, at 1. Respondent's attorney further reported that 14 of the customers had “never purchased a list I” product and that three of them “have a DEA license.”
Respondent's attorney further wrote that it “had tightened up * * * his business with regard to checking out the customer on all sales pertaining to list I chemicals.”
At the hearing, Mr. Sayani testified that he did not go to a new customer's store to verify whether it was legitimate “because at the time of opening the account, we get enough proof from them that they're legitimate * * * or that they're who they say” they are. Tr. 768. Mr. Sayani acknowledged, however, that anyone who applied for a state or local tax identification number would be issued one.
At the hearing, Mr. Sayani further testified that upon being served with the Show Cause Order, which referred to Max Brand and Heads Up as non-traditional products, he stopped selling the products.
Contrary to Mr. Sayani's testimony, Respondent's “Sales Tracking Report” indicates that it repeatedly sold Max Brand after the first Show Cause Order was served and frequently did so in large quantities. Moreover, there is evidence that it made multiple large sales to several stores.
For example, on November 30, 2004, it sold $504 of Max Brand 2–Way to the Lucky Star of Brookfield, Georgia. RX 12, at 67. This was followed by two December 12, 2004 sales, each totaling $1509.84, to the Dixie Stop of Twion and the Modern Kwik Shop of Summerville,
On both November 29, 2004, and January 3, 2005, it sold $1006.56 of the products to ABJ Ashburn, Inc., of Ashburn.
Moreover, on January 8, 2005, it sold $861.12 of Max Brand pseudoephedrine to Priya Nidhi, Inc., of Calhoun, Georgia.
On February 5, 2005, it made two separate sales of the products (one totaling $504, the other totaling $430.56) to the West Gray BP of Gray, Georgia,
On January 13, February 6, March 1, and April 1, 2005, it sold $430.56 worth of the products to the Texaco 10 Opelika of Phenix City, Alabama; on January 13, it also sold an additional $576 of the products to this store.
The evidence further shows numerous other instances in which Respondent sold large quantities of Max Brand as late as April 2005.
The ALJ specifically found—based on Mr. Sayani's testimony—that “Respondent stopped selling Heads Up and Max Brand products because they were identified as ‘non-traditional’ items by the DEA in the October 2004 Order to Show Cause.” ALJ at 21. To the extent this finding implies that Mr. Sayani stopped selling the products shortly after service of the Order, it is inconsistent with the evidence which shows that for approximately five months after the Order was served, Respondent continued to sell these products. Indeed, Mr. Sayani's testimony begs the question of why, if the products were identified in the Show Cause Order, it took five months to stop selling them.
The Government also produced evidence showing that Respondent had distributed iodine tincture to several of its customers.
Regarding the allegation that Respondent sold excessive quantities of iodine to convenience stores, the Government offered anecdotal evidence in the form of a DI's testimony that she had visited more than 100 convenience stores in both the course of her official duties and as a consumer and had never been able to find tincture of iodine. Tr. 396. But in contrast to the extensive evidence the Government introduced regarding the expected sales range of pseudoephedrine and ephedrine at convenience stores, it produced no such evidence with respect to iodine tincture.
The Government also introduced into evidence several documents indicating that iodine was used in manufacturing methamphetamine. The first of these was a blue notice, which was reprinted in the
The Government also introduced into evidence an “Information Brief” published by the National Drug Intelligence Center entitled:
To counter the Government, Respondent introduced a copy of a Notice of Proposed Rulemaking (NPRM) in which the Agency proposed “the control of chemical mixtures containing greater than 2.2 percent iodine.” DEA,
In discussing the rationale for the proposed rule, the NPRM further explained that because “seven percent iodine tincture and solutions are the predominant iodine-containing chemical mixtures diverted by traffickers * * * these chemical mixtures should be subject to CSA chemical regulatory controls.”
Respondent also called as a witness a sales representative for the company which supplied him with iodine tincture. The sales rep. testified that he had sold Respondent iodine tincture with an iodine concentration of only one to two percent, Tr. 437–38, and there is no evidence refuting this.
Section 304(a) of the Controlled Substances Act provides that a registration to distribute a list I chemical “may be suspended or revoked * * * upon a finding that the registrant * * * has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). Moreover, under section 303(h), “[t]he Attorney General shall register an applicant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest.” 21 U.S.C. 823(h). In making the public interest determination, Congress directed that the following factors be considered:
(1) Maintenance by the applicant of effective controls against diversion of listed chemicals into other than legitimate channels;
(2) Compliance by the applicant with applicable Federal, State, and local law;
(3) Any prior conviction record of the applicant under Federal or State laws relating to controlled substances or to chemicals controlled under Federal or State law;
(4) Any past experience of the applicant in the manufacture and distribution of chemicals; and
(5) Such other factors as are relevant to and consistent with the public health and safety.
“These factors are considered in the disjunctive.”
While I reject the Government's allegations based on Respondent's sales of iodine tincture, I nonetheless conclude that the evidence under factors one, four, and five make out as
Finally, I reject Respondent's argument that revoking his registration would violate its constitutional right to due process because it has not sold listed chemicals “in excess of the quantities authorized in the published rules * * * of the DEA.” Resp. Prop. Findings at 16. I also find unavailing his claim—based on the ALJ's finding that his inventory procedures were inadequate—that it “is once again being asked to comply with something that is not in the DEA rules,” and that this is another violation of its right to due process. Resp. Exceptions at 6. Accordingly, Respondent's Forest Park registration will be revoked; its pending renewal application for its Forest Park facility and its application for a registration at its Decatur facility will also be denied.
Under DEA precedent and regulations, this factor encompasses a variety of considerations and is not limited to whether the registrant maintains adequate physical security of listed chemical products. ALJ at 29–30. A DEA regulation requires the consideration of the adequacy of a registrant's “systems for monitoring the receipt, distribution, and disposition of List I chemicals in its operations.” 21 CFR 1309.71(b)(8). Relatedly, a registrant must exercise a high degree of care in monitoring its customer's purchases.
It is undisputed that Respondent upgraded its physical security by building storage cages, installing video cameras, and assigning a person to distribute the products from the cage. This, however, is only one part of a registrant's obligation to maintain effective controls against diversion.
Here, the record shows that Respondent's procedures for verifying the legitimacy of its listed chemical customers were wholly inadequate to prevent diversion. Moreover, those procedures remain so. While following the meeting in which agency investigators notified Respondent of their concerns regarding the legitimacy of its customers, Respondent's counsel stated that it had “tightened up” its procedures and was requiring that its customers produce a tax identification number and business license, RX 8, at 1–2 2, these documents can be easily obtained by anyone. While Mr. Sayani
Moreover, Respondent generally operated as a “cash and carry” business and only delivered if a customer ordered at least $ 1,000 worth of the items and requested that it do so. Thus, a customer could be obtaining listed chemical products from multiple sources and Respondent would have no knowledge of this.
As the results of the customer verifications demonstrate, Respondent was indifferent to its obligation to determine whether a potential list I customer had a legitimate need for the products. Moreover, Mr. Sayani's testimony indicates that Respondent did not change its practices. Indeed, Respondent's practices are fundamentally inconsistent with its obligations as a registrant, and are a prescription for wide-spread diversion.
Buttressing this finding is the evidence pertaining to the audit. As found above, the audit, which covered a six-month period, found that Respondent had massive shortages of several listed chemical products including 7640 sixty-count bottles of Head Up, 3656 sixty-count bottles of Max Brand, and 284 sixty-count bottles of Mini 2-Way Action.
Based on the ALJ's finding that its “lack of an inventory system, alone, provides persuasive weight against Respondent's continued registration,” ALJ at 30 n.6, Respondent argues that “there is no requirement under any of the DEA rules to have an inventory system, and [that it] is * * * being asked to comply with something that is not in the DEA rules.” Resp. Exceptions at 6. Respondent contends that it is “being held to * * * unpublished DEA guidelines,” and that this is “a violation of due process * * * and equal protection guarantees.”
Respondent is correct that there is no regulation which explicitly requires that it maintain an inventory system. However, in enacting section 303(h), Congress made plain that in determining the public interest, the Attorney General was to consider the applicant's (and in a revocation/suspension proceeding, the registrant's) “maintenance * * * of effective controls against diversion of listed chemicals into other than legitimate channels.” 21 U.S.C. 823(h).
Moreover, in 1995, DEA promulgated 21 CFR 1309.71(a), which directed that “[a]ll applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of List I chemicals.” This regulation, which remains in effect, further explained that “[i]n evaluating the effectiveness of security controls and procedures, the Administrator shall consider * * * [t]he adequacy of the registrant's or applicant's systems for monitoring the receipt, distribution, and disposition of List I chemicals in its operations.” 21 CFR 1309.71(b)(8).
Federal law further requires that a registrant report “any regulated transaction involving an extraordinary quantity of a listed chemical,” 21 U.S.C. 830(b)(1)(A), and a “regulated transaction” is based on “the quantitative threshold or the cumulative amount for multiple transactions within a calendar month.” 21 CFR 1310.04(f). Federal law also requires a distributor to report to this Agency “any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person.” 21 U.S.C. 830(b)(1)(C). Accordingly, to satisfy 21 CFR 1309.71(b)(8), a registrant's recordkeeping must be sufficient so as to enable it to comply with its reporting obligations under Federal law.
Here, Respondent has no satisfactory explanation as to the disposition of approximately 11,580 sixty-count bottles or 695,000 dosage units of listed chemical products. Whether the shortages are due to poor recordkeeping, theft, or some other reason, the magnitude of these shortages provides a further reason to conclude that Respondent does not maintain effective controls against diversion and that its continued registration would be “inconsistent with the public interest.” 21 U.S.C. 823(h).
Under this factor, the ALJ further concluded that Respondent made “excessive sales of both list one chemical products and iodine” that “pose a risk to the public interest.” ALJ at 32. While the ALJ found the testimony of Respondent's expert “more persuasive” than the Government's evidence on the expected sales level of list I chemical products, as she further explained, even the Respondent's expert witness “concurred that some of the [sales of] Respondent's List I chemical products * * * were in excess of what would be expected.” Id. at 33. While I adopt the ALJ's conclusions with respect to list I chemicals, I reject them with respect to iodine.
With respect to its distributions of iodine, the ALJ found that “Respondent has knowingly distributed large amounts of 2% iodine, another methamphetamine precursor.” ALJ at 32. In support of her conclusion, the ALJ relied on the testimony of Respondent's expert that there were “five instances where the quantity [of iodine] purchased might be suspiciously high,” Tr. 571, as well as on Mr. Sayani's testimony that he was aware that one of his customers was purchasing hundreds of bottles but that he thought the customer was distributing to other small retailers.
The Government's own evidence establishes, however, that the 2% iodine product which Respondent sold “is not regulated by law,” GX 36B at 2, and the NPRM which announced the Agency's intent to regulated iodine tinctures containing more than 2.2 percent iodine noted that 2% iodine tincture products “are sold at a wide variety of retail outlets and have household application as antiseptic and antimicrobial products.” 71 FR 46146. The same NPRM also explained that the “frequent diversion” of two percent iodine tincture at clandestine laboratories “has not [been] documented.”
Furthermore, DEA's regulations provide that two conditions must be met for a chemical mixture to be exempted from regulation. 21 CFR 1310.13(a). First, “[t]he mixture [must be] formulated in such a way that it cannot be easily used in the illicit production of a controlled substance.”
Here, there is no evidence that Respondent sold these products with knowledge that they would be diverted for use in the illicit manufacture of methamphetamine, and in any event, the Government's allegation that Respondent was selling excessive amounts of iodine tincture is not supported by substantial evidence. The Government's evidence is limited to the testimony of a diversion investigator that she had visited 100 convenience stores and had never found iodine tincture. Yet the Agency's NPRM noted that these products, which have several legitimate uses, are sold at “a wide variety of retail outlets.” 71 FR at 46146.
More importantly, even assuming that the investigator was specifically looking for iodine tincture at the convenience stores she visited, the testimony amounts to nothing more than anecdotal evidence. As such, it does not conclusively establish the extent to which these products are sold at convenience stores and the statistical improbability that Respondent's sales of these products were to meet legitimate demand. Indeed, the evidence stands in contrast to the quantum of the evidence the Government introduced regarding the expected sales levels of list I chemical products at convenience stores.
On the other hand, Respondent's sales of list I chemical products clearly were excessive and support a finding that its continued registration is inconsistent with the public interest. Even assuming that the monthly expected sales figure of $173 for pseudoephedrine given by Respondent's expert is accurate, and that some stores might make a legitimate business decision to purchase a case quantity to reduce their costs, the evidence shows that Respondent repeatedly sold case quantities to multiple customers including the Coastal Food Mart, Chitra Inc.'s Quick Stop, the Phillips 66 Mart, the R & S Grocery, and the Stop In.
The evidence also shows that Respondent sold case quantities to two customers which gave the same address. For example, between January 6 and August 1, 2004, Respondent sold a total of eleven cases to the P & K Mini Mart and the Quick Stop/Tushar/BP, both of which used the same address. Moreover, between January 6 and September 5, 2004, it sold a total of fifteen cases to the DJ Food Mart and BJ Food Market #1, which gave their respective addresses as 15582 HWY 27 and 15582 HWY 27 North in Trion, Georgia.
With respect to the Coastal Food Mart, which purchased eight cases between January 21 and September 5, 2004, even Respondent's expert acknowledged that this store's purchases were many times the expected norm. Tr. 619–20. And as found above, several of Respondent's customers purchased even larger amounts of list I chemical products than did the Coastal Food Mart. As Respondent's expert allowed with respect to those customers who were repeatedly purchasing large quantities, “maybe there's some nefarious practice involved here” and the customers are “doing something that * * * they shouldn't be doing.”
Respondent raises two arguments in response to the allegations that it sold excessive quantities of list I chemical products. First, it argues that given the nature and size of its business, it would be “almost impossible to find” the excessive sales. Resp. Prop. Findings at 15.
Second, it argues that is “has not sold any restricted item in excess of the quantities authorized in the published rules and regulations * * * which show the threshold quantities of restricted items the wholesalers * * * are allowed to sell without * * * putting their DEA license at risk.”
As for the argument that it would be nearly impossible to detect excessive purchases, Respondent's expert acknowledged that a computer program could be written to detect such purchases. Tr. 648. Nor would it require more than minimal effort to call up a customer's account to determine the frequency and amounts of its purchases before selling additional amounts of the products to it.
Also unavailing is Respondent's contention that because it did not sell more than the threshold quantities, its registration cannot be revoked. Contrary to Respondent's understanding, selling under threshold amounts does not relieve a registrant from its obligation to taking necessary measures “to determine the ultimate disposition of [its] products.”
Congress's imposition of recordkeeping and reporting requirements for regulated transactions does not mean that one can engage in below-threshold transactions without any further obligation to determine whether the products are likely to be diverted. Indeed, DEA has found that products which have been distributed to non-traditional retailers in sub-threshold transactions are routinely diverted. Contrary to Respondent's view, the threshold provisions pertaining to regulated transactions do not create a safe harbor which allows a registrant to sell list I chemicals without any further duty to investigate how the products are being used.
Finally, there is no merit to Respondent's related contention that it has been denied fair “notice as to what specific action would be violative of [DEA's] rules and regulations.” Resp. Prop. Findings at 18. Contrary to
In section 304(a), Congress made clear that a registration is subject to revocation where a registrant “has committed such acts as would render his registration * * * inconsistent with the public interest as determined under” under section 303. 21 U.S.C. 824(a)(4). And in section 303(h), Congress clearly provided that one of the criteria for determining the public interest is whether a registrant maintains “effective controls against diversion of listed chemicals into other than legitimate channels.”
Moreover, in several decisions which pre-dated nearly all of the listed chemical distributions discussed above, this Agency made clear that selling in quantities that greatly exceed legitimate demand for these products supports a finding of diversion and that such conduct can be the basis for the revocation of a registration.
The
Respondent's argument rings hollow for another reason. In the first Show Cause Order, Respondent was put on notice that “Max Brand products have been found on numerous occasions in situations related to the illicit manufacture of methamphetamine,” Show Cause Order I, at 3; that the monthly expected sales range of pseudoephedrine products at convenience stores in Georgia “averaged between $15 and $60,”
Accordingly, while Respondent was authorized to distribute list I chemicals for approximately six years, its experience is characterized by its frequent disregard of its obligation to protect against the diversion of these products. This conclusion provides an additional basis, which is sufficient by itself, to find that Respondent's continued registration is “inconsistent with the public interest.” 21 U.S.C. 823(h).
As found above, the illicit manufacture and abuse of methamphetamine have had pernicious effects on families and communities throughout the nation.
While listed chemical products containing both ephedrine and pseudoephedrine have legitimate medical uses, DEA orders have established that convenience stores, gas-stations, and other small retailers, constitute the non-traditional retail market for legitimate consumers of products containing these chemicals.
The record here likewise establishes a substantial nexus between the sale of non-traditional list I chemicals products and the diversion of these products into the illicit manufacture of
The record establishes that Respondent's list I customer base was comprised primarily of the same type of establishments. More specifically, Respondent's list I customers included gas stations, convenience stores, dollar stores, liquor stores, beauty stores, gift shops, and some customers (such as those located at private residences) whose business was not even clear. As the ALJ observed “[s]ome of these businesses did not even appear to be tangentially related to the legitimate sale of pseudoephedrine and ephedrine products.” ALJ at 34. As the ALJ further noted, notwithstanding the substantial risk of diversion present when distributing to these establishments, as well as the testimony that non-traditional retailers were the primary supply source for illicit meth. cooks, Respondent offered no evidence that it “would cease dealing with” these establishments.
Moreover, while Respondent disputed the amount of monthly sales of pseudoephedrine at convenience stores to meet legitimate demand, it did not challenge the Government's evidence that sales of non-prescription drugs account for only a small percentage of the total sales of convenience stores that handle the products. Nor did it offer any evidence to refute the Government's evidence that only a small number (approximately two in one thousand) of convenience store customers purchase a pseudoephedrine product. And even using the monthly expected sales figures put forth by its expert, as found above, Respondent repeatedly sold to multiple non-traditional retailers quantities of list I chemical products that greatly exceeded legitimate demand for these products.
Having concluded that the Government made out its
The ALJ nonetheless concluded that Respondent “does demonstrate a willingness to comply with DEA directions” because it did not handle list I chemical products at its Decatur location while its application was pending and at its Forest Park location after that registration was suspended. ALJ at 34–35. The ALJ also reasoned that Respondent “stopped selling non-traditional listed chemical products in 2004, after the DEA served its first Order to Show Cause.”
Both the handling of a list I chemical product at an unregistered location and the distribution of a list I product out of a location with a suspended registration would, however, constitute felony offenses under Federal law.
As found above, Respondent continued selling non-traditional products—and made numerous large quantity transactions—well into April 2005, approximately five to six months after service of the first Show Cause Order. Indeed, Mr. Sayani's testimony regarding when Respondent stopped selling the products is clearly refuted by the documentary evidence. The weight of the evidence thus does not support the ALJ's conclusion that Respondent is willing to comply with DEA's direction.
In any event, notwithstanding her finding, the ALJ concluded that Respondent's “cooperation is dwarfed by the significant risk of diversion posed to the public by * * * Respondent's continued sales of listed chemical products to [non-traditional retailers] without adequate sales records or customer verification.” ALJ at 35. While Respondent contends that the ALJ “ignore[d] the substantial remedial actions that [it] had taken to correct [the] problems of which” it was notified, Resp. Exceptions at 6, the ALJ considered them and properly concluded that they only partially addressed the problems identified by the Agency.
In short, Respondent offered no evidence of its willingness to change its practices for determining whether its customers are legitimate. It offered no evidence that it has in place systems to accurately account for the products it handles and to properly identify those customers who are purchasing excessive quantities.
Likewise, it has offered no credible evidence that it is willing to change its practices to limit its sales of these products. Its claim that it stopped selling the products shortly after service of the first Show Cause Order, is contradicted by the documentary evidence. Moreover, its argument that the thresholds establish the “quantities of restricted items the wholesalers * * * are allowed to sell without * * * putting their DEA license at risk, [and] are what both the Government and the public are bound to abide by,” Resp. Prop. Findings at 16—a theme which is repeated throughout its brief—makes plain its view that it can continue to sell up to the thresholds with no obligation to limit its distributions to those establishments at which there is only limited consumer demand for these products for their lawful use. Because this view is fundamentally inconsistent with a distributor's obligation under the CSA, I conclude that Respondent's registration “is inconsistent with the public interest.” 21 U.S.C. 823(h).
Respondent does not argue that the statute is unconstitutional. Nor could it, as the Supreme Court has repeatedly upheld the use of post-deprivation process in emergency situations.
Finally, Respondent asserts that “the effect of the DEA's arbitrary actions [in its] case [is] to discriminate against him because he is a legal alien” in violation of his right to equal protection of the laws. Resp. Prop. Findings at 25. Respondent does not, however, contend that the Agency is intentionally discriminating against its owner,
Pursuant to the authority vested in me by 21 U.S.C. 823(h) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I order that DEA Certificate of Registration, 040450SLY, issued to Sunny Wholesale, Inc., 120 Forest Parkway, Forest Park, Georgia, be, and it hereby is, revoked, and that its application to renew this registration be, and it hereby is, denied. I further order that Sunny Wholesale, Inc.'s, application for a DEA Certificate Registration at 2935 N. Decatur Road, Suite C, Decatur, Georgia, be, and it hereby is, denied. These orders are effective November 3, 2008.